[Federal Register Volume 84, Number 227 (Monday, November 25, 2019)]
[Rules and Regulations]
[Pages 64754-64765]
[FR Doc No: 2019-24946]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Parts 9 and 721

[EPA-HQ-OPPT-2018-0627; FRL-10001-30]
RIN 2070-AB27

Significant New Use Rules on Certain Chemical Substances (18-1)

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: EPA is issuing significant new use rules (SNURs) under the
Toxic Substances Control Act (TSCA) for 22 chemical substances which
are the subject of premanufacture notices (PMNs). The chemical
substances are subject to Orders issued by EPA under TSCA. This action
requires persons who intend to manufacture (defined by

statute to include import) or process any of these chemical substances
for an activity that is designated as a significant new use by this
rule to notify EPA at least 90 days before commencing that activity.
Persons may not commence manufacture or processing for the significant
new use until EPA has conducted a review of the notice, made an
appropriate determination on the notice, and has taken such actions as
are required by that determination.

DATES: This rule is effective on January 24, 2020. For purposes of
judicial review, this rule shall be promulgated at 1 p.m. (EST) on
December 9, 2019.

FOR FURTHER INFORMATION CONTACT:
    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:<PHONE_NUMBER>; email address:
<EMAIL_ADDRESS>    For general information contact: The TSCA-Hotline, ABVI-Goodwill,
422 South Clinton Ave., Rochester, NY 14620; telephone number: (202)
554-1404; email address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this action apply to me?

    You may be potentially affected by this action if you manufacture,
process, or use the chemical substances contained in this rule. The
following list of North American Industrial Classification System
(NAICS) codes is not intended to be exhaustive, but rather provides a
guide to help readers determine whether this document applies to them.
Potentially affected entities may include:
     Manufacturers or processors of one or more subject
chemical substances (NAICS codes 325 and 324110), e.g., chemical
manufacturing and petroleum refineries.
    This action may also affect certain entities through pre-existing
import certification and export notification rules under TSCA. Chemical
importers are subject to the TSCA section 13 (15 U.S.C. 2612) import
certification requirements promulgated at 19 CFR 12.118 through 12.127
and 19 CFR 127.28. Chemical importers must certify that the shipment of
the chemical substance complies with all applicable rules and Orders
under TSCA. Importers of chemicals subject to these SNURs must certify
compliance with the SNUR requirements. The EPA policy in support of
import certification appears at 40 CFR part 707, subpart B. In
addition, any persons who export or intend to export a chemical
substance that is the subject of this rule on or after December 26,
2019 are subject to the export notification provisions of TSCA section
12(b) (15 U.S.C. 2611(b)) (see 40 CFR 721.20), and must comply with the
export notification requirements in 40 CFR part 707, subpart D.

B. What action is the agency taking?

    EPA is finalizing these SNURs under TSCA section 5(a)(2) for 22
substances which were the subject of PMNs. These SNURs require persons
who intend to manufacture or process any of these chemical substances
for an activity that is designated as a significant new use to notify
EPA at least 90 days before commencing that activity. EPA is not
finalizing four proposed SNURs at 40 CFR 721.11150, 721.11163,
721.11164, and 721.11165 for the chemical substances P-14-627, P-17-
200, P-17-204, and P-17-205, respectively, because the Agency is
currently reviewing data submitted in support of a request to modify
the underlying TSCA 5(e) Orders that forms the basis for the proposed
SNURs.
    In the Federal Register of October 3, 2018 (83 FR 49903) (FRL-9983-
81), EPA proposed a SNUR for 26 chemical substances in 40 CFR part 721,
subpart E. This comment period closed on November 2, 2018. More
information on the specific chemical substances subject to this final
rule can be found in the Federal Register documents for the direct
final SNUR of October 3, 2018 (83 FR 49806) (FRL-9983-82). This direct
final SNUR was withdrawn on December 4, 2018 (83 FR 62463) (FRL-9986-
74) due to adverse public comments related to SNURs identified in the
document.
    The record for the batch SNUR was established in the docket under
docket ID number EPA-HQ-OPPT-2018-0627. That docket includes
information considered by the Agency in developing the proposed and
final rules, public comments submitted for the rule, and EPA's
responses to public comments received on the proposed rule.

C. What is the agency's authority for taking this action?

    TSCA section 5(a)(2) (15 U.S.C. 2604(a)(2)) authorizes EPA to
determine that a use of a chemical substance is a ``significant new
use.'' EPA must make this determination by rule after considering all
relevant factors, including the four TSCA section 5(a)(2) factors
listed in Unit II.

D. Applicability of General Provisions

    General provisions for SNURs appear in 40 CFR part 721, subpart A.
These provisions describe persons subject to the rule, recordkeeping
requirements, exemptions to reporting requirements, and applicability
of the rule to uses occurring before the effective date of the rule.
Provisions relating to user fees appear at 40 CFR part 700. According
to 40 CFR 721.1(c), persons subject to these SNURs must comply with the
same SNUN requirements and EPA regulatory procedures as submitters of
PMNs under TSCA section 5(a)(1)(A). These requirements include the
information submission requirements of TSCA section 5(b) and 5(d)(1),
the exemptions authorized by TSCA section 5(h)(1), (h)(2), (h)(3), and
(h)(5), and the regulations at 40 CFR part 720. Once EPA receives a
SNUN, EPA must either determine that the use is not likely to present
an unreasonable risk of injury under the conditions of use for the
chemical substance or take such regulatory action as is associated with
an alternative determination before the manufacture or processing for
the significant new use can commence. In the case of a determination
other than not likely to present unreasonable risk, the applicable
review period must also expire before manufacturing or processing for
the new use may commence. If EPA determines that the use is not likely
to present an unreasonable risk, EPA is required under TSCA section
5(g) to make public, and submit for publication in the Federal
Register, a statement of EPA's findings.

II. Significant New Use Determination

    When the Agency issues an Order under TSCA section 5(e), TSCA
section 5(f)(4) requires that the Agency consider whether to promulgate
a SNUR for any use not conforming to the restrictions of the Order or
publish a statement describing the reasons for not initiating the
rulemaking. TSCA section 5(a)(2) states that EPA's determination that a
use of a chemical substance is a significant new use must be made after
consideration of all relevant factors, including:
     The projected volume of manufacturing and processing of a
chemical substance.
     The extent to which a use changes the type or form of
exposure of human beings or the environment to a chemical substance.
     The extent to which a use increases the magnitude and
duration of exposure of human beings or the environment to a chemical
substance.

     The reasonably anticipated manner and methods of
manufacturing, processing, distribution in commerce, and disposal of a
chemical substance.
    In determining what would constitute a significant new use for the
chemical substances that are the subject of these SNURs, EPA considered
relevant information about the toxicity of the chemical substances,
likely human exposures and environmental releases associated with
possible uses, and the four TSCA section 5(a)(2) factors listed in this
unit.

III. Public Comments on Proposed Rule and EPA Responses

    EPA received public comments from three identifying entities on the
proposed rule. The Agency's responses are described in a separate
Response to Public Comments document contained in the public docket for
this rule, EPA-HQ-OPPT-2018-0627. In addition, EPA is not finalizing
the proposed SNURs for the substances described in P-14-627, P-17-200,
P-17-204, and P-17-205 (40 CFR 721.11150, 721.11163, 721.11164, and
721.11165, respectively) because the Agency is currently reviewing data
submitted in support of a request to modify the underlying TSCA 5(e)
Orders that form the basis for the proposed SNURs. EPA will finalize
those proposed SNURs after the data has been reviewed and any changes
to the Orders and/or SNUR have been considered and identified.
    Furthermore, the Response to Comments describes comments and
responses that resulted in changes to the SNURs for P-17-24 and P-17-
25. The regulatory text of the SNURs at 40 CFR 721.11159 and 40 CFR
721.11160 have been revised to include that dust inhalation exposure is
a significant new use and to specify a significant new use as
commercial use when saleable goods or service could introduce the PMN
substances into a consumer setting.

IV. Substances Subject to This Rule

    EPA is establishing significant new use and recordkeeping
requirements for 22 chemical substances in 40 CFR part 721, subpart E.
In Unit IV. of the original direct final rule (83 FR 49806, October 3,
2018), EPA provides the following information for each chemical
substance:
     PMN number.
     Chemical name (generic name, if the specific name is
claimed as CBI).
     Chemical Abstracts Service (CAS) Registry number (if
assigned for non-confidential chemical identities).
     Basis for the TSCA section 5(e) Order.
     Potentially Useful Information. This is information
identified by EPA that would help characterize the potential health
and/or environmental effects of the chemical substance in support of a
request by the PMN submitter to modify the Order, or if a manufacturer
or processor is considering submitting a SNUN for a significant new use
designated by the SNUR.
     CFR citation assigned in the regulatory text section of
this rule.
    The regulatory text section of each rule specifies the activities
designated as significant new uses. Certain new uses, including
exceedance of production volume limits (i.e., limits on manufacture
volume) and other uses designated in this rule, may be claimed as CBI.
Unit VII. discusses a procedure companies may use to ascertain whether
a proposed use constitutes a significant new use.
    These final rules include 22 PMN substances that are subject to
Orders under TSCA section 5(e)(1)(A)(ii)(I) where EPA determined that
activities associated with the PMN substances may present unreasonable
risk to human health or the environment. Those Orders require
protective measures to limit exposures or otherwise mitigate the
potential unreasonable risk. The SNURs identify as significant new uses
any manufacturing, processing, use, distribution in commerce, or
disposal that does not conform to the restrictions imposed by the
underlying Orders, consistent with TSCA section 5(f)(4).

V. Rationale and Objectives of the Rule

A. Rationale

    During review of the PMNs submitted for the chemical substances
that are subject to these SNURs, EPA concluded that regulation was
warranted under TSCA section 5(e), pending the development of
information sufficient to make reasoned evaluations of the health or
environmental effects of the chemical substances. The basis for such
findings is outlined in Unit IV of the October 3, 2018 direct final
rule. Based on these findings, TSCA section 5(e) Orders requiring the
use of appropriate exposure controls were negotiated with the PMN
submitters. As a general matter, EPA believes it is necessary to follow
TSCA section 5(e) Orders with a SNUR that identifies the absence of
those protective measures as Significant New Uses to ensure that all
manufacturers and processors--not just the original submitter--are held
to the same standard.

B. Objectives

    EPA is issuing these SNURs because the Agency wants:
     To identify as significant new uses any manufacturing,
processing, use, distribution in commerce, or disposal that does not
conform to the restrictions imposed by the underlying Orders,
consistent with TSCA section 5(f)(4).
     To receive notice of any person's intent to manufacture or
process a listed chemical substance for the described significant new
use before that activity begins.
     To have an opportunity to review and evaluate data
submitted in a SNUN before the notice submitter begins manufacturing or
processing a listed chemical substance for the described significant
new use.
     To be able to either determine that the prospective
manufacture or processing is not likely to present an unreasonable
risk, or to take necessary regulatory action associated with any other
determination, before the described significant new use of the chemical
substance occurs.
    Issuance of a SNUR for a chemical substance does not signify that
the chemical substance is listed on the TSCA Chemical Substance
Inventory (TSCA Inventory). Guidance on how to determine if a chemical
substance is on the TSCA Inventory is available on the internet at
http://www.epa.gov/opptintr/existingchemicals/pubs/tscainventory/index.html.

VI. Applicability of the Significant New Use Designation

    To establish a significant new use, EPA must determine that the use
is not ongoing. The chemical substances subject to this rule have
undergone premanufacture review. In cases where EPA has not received a
notice of commencement (NOC) and the chemical substance has not been
added to the TSCA Inventory, no person may commence such activities
without first submitting a PMN. Therefore, for chemical substances for
which an NOC has not been submitted, EPA concludes that the designated
significant new uses are not ongoing.
    When chemical substances identified in this rule are added to the
TSCA Inventory, EPA recognizes that, before the rule is effective,
other persons might engage in a use that has been identified as a
significant new use. However, TSCA section 5(e) Orders have been issued
for all the chemical substances, and the PMN submitters are prohibited
by the TSCA section 5(e) Orders from undertaking activities which will
be designated as significant new uses. The

identities of 14 of the 22 chemical substances subject to this rule
have been claimed as confidential. Based on this, the Agency believes
that it is highly unlikely that any of the significant new uses
described in the regulatory text of this rule are ongoing.
    Furthermore, EPA designated October 3, 2018 (the date of public
release of the original direct final and proposed rules) as the cutoff
date for determining whether the new use is ongoing. The objective of
EPA's approach has been to ensure that a person could not defeat a SNUR
by initiating a significant new use before the effective date of the
final rule.
    In the unlikely event that a person began commercial manufacture or
processing of the chemical substances for a significant new use
identified as of October 3, 2018, that person will have to cease any
such activity upon the effective date of the final rule. To resume
their activities, these persons will have to first comply with all
applicable SNUR notification requirements and wait until EPA has
conducted a review of the notice, made an appropriate determination on
the notice, and has taken such actions as are required with that
determination.

VII. Development and Submission of Information

    EPA recognizes that TSCA section 5 does not require developing any
particular new information (e.g., generating test data) before
submission of a SNUN. There is an exception: If a person is required to
submit information for a chemical substance pursuant to a rule, Order
or consent agreement under TSCA section 4 (15 U.S.C. 2603), then TSCA
section 5(b)(1)(A) (15 U.S.C. 2604(b)(1)(A)) requires such information
to be submitted to EPA at the time of submission of the SNUN.
    In the absence of a rule, Order, or consent agreement under TSCA
section 4 covering the chemical substance, persons are required only to
submit information in their possession or control and to describe any
other information known to or reasonably ascertainable (see 40 CFR
720.50). However, upon review of PMNs and SNUNs, the Agency has the
authority to require appropriate testing under 40 CFR part 721, subpart
E. In Unit IV. of the original direct final rule (October 3, 2018; 83
FR 49806), the EPA lists potentially useful information that will be
useful to EPA's evaluation. Companies who are considering submitting a
SNUN are encouraged, but not required, to develop the information on
the substance. EPA strongly encourages persons, before performing any
testing, to consult with the Agency. Furthermore, pursuant to TSCA
section 4(h), which pertains to reduction of testing on vertebrate
animals, EPA encourages consultation with the Agency on the use of
alternative test methods and strategies (also called New Approach
Methodologies, or NAMs), if available, to generate the recommended test
data. EPA encourages dialog with Agency representatives to help
determine how best the submitter can meet both the data needs and the
objective of TSCA section 4(h).
    In some of the TSCA section 5(e) Orders for the chemical substances
regulated under this rule, EPA has established production volume
limits. These limits cannot be exceeded unless the PMN submitter
submits the results of specified tests. The SNURs contain the same
production volume limits as the TSCA section 5(e) Orders. Exceeding
these production limits is defined as a significant new use. Persons
who intend to exceed the production limit must notify the Agency by
submitting a SNUN at least 90 days in advance of commencement of non-
exempt commercial manufacture or processing.
    Any request by EPA for the triggered and pended testing described
in the Orders was made based on EPA's consideration of available
screening-level data, if any, as well as other available information on
appropriate testing for the PMN substances. Further, any such testing
request on the part of EPA that includes testing on vertebrates was
made after consideration of available toxicity information,
computational toxicology and bioinformatics, and high-throughput
screening methods and their prediction models.
    The potentially useful information identified in Unit IV. of the
original direct final rule may not be the only means of addressing the
potential risks of the chemical substance. However, submitting a SNUN
without any test data or other information may increase the likelihood
that EPA will take action under TSCA section 5(e) or 5(f). EPA
recommends that potential SNUN submitters contact EPA early enough so
that they will be able to conduct the appropriate tests.
    SNUN submitters should provide detailed information on the
following:
     Human exposure and environmental release that may result
from the significant new use of the chemical substances.
     Information on risks posed by the chemical substances
compared to risks posed by potential substitutes.

VIII. Procedural Determinations

    By this rule, EPA is establishing certain significant new uses
which have been claimed as CBI subject to Agency confidentiality
regulations at 40 CFR part 2 and 40 CFR part 720, subpart E. Absent a
final determination or other disposition of the confidentiality claim
under 40 CFR part 2 procedures, EPA is required to keep this
information confidential. EPA promulgated a procedure to deal with the
situation where a specific significant new use is CBI, at 40 CFR
721.1725(b)(1).
    Under these procedures a manufacturer or processor may request EPA
to determine whether a proposed use would be a significant new use
under the rule. The manufacturer or processor must show that it has a
bona fide intent to manufacture or process the chemical substance and
must identify the specific use for which it intends to manufacture or
process the chemical substance. If EPA concludes that the person has
shown a bona fide intent to manufacture or process the chemical
substance, EPA will tell the person whether the use identified in the
bona fide submission would be a significant new use under the rule.
Since most of the chemical identities of the chemical substances
subject to these SNURs are also CBI, manufacturers and processors can
combine the bona fide submission under the procedure in 40 CFR
721.1725(b)(1) with that under 40 CFR 721.11 into a single step.
    If EPA determines that the use identified in the bona fide
submission would not be a significant new use, i.e., the use does not
meet the criteria specified in the rule for a significant new use, that
person can manufacture or process the chemical substance so long as the
significant new use trigger is not met. In the case of a production
volume trigger, this means that the aggregate annual production volume
does not exceed that identified in the bona fide submission to EPA.
Because of confidentiality concerns, EPA does not typically disclose
the actual production volume that constitutes the use trigger. Thus, if
the person later intends to exceed that volume, a new bona fide
submission would be necessary to determine whether that higher volume
would be a significant new use.

IX. SNUN Submissions

    According to 40 CFR 721.1(c), persons submitting a SNUN must comply
with the same notification requirements and EPA regulatory procedures
as persons submitting a PMN, including submission of test data on
health and environmental effects as described in 40

CFR 720.50. SNUNs must be submitted on EPA Form No. 7710-25, generated
using e-PMN software, and submitted to the Agency in accordance with
the procedures set forth in 40 CFR 720.40 and 721.25. E-PMN software is
available electronically at http://www.epa.gov/opptintr/newchems.

X. Economic Analysis

    EPA has evaluated the potential costs of establishing SNUN
requirements for potential manufacturers and processors of the chemical
substances subject to this rule. EPA's complete economic analysis is
available in the docket under docket ID number EPA-HQ-OPPT-2018-0627.

XI. Statutory and Executive Order Reviews

    Additional information about these statutes and Executive Orders
can be found at https://www.epa.gov/laws-regulations-and-executive-orders.

A. Executive Order 12866: Regulatory Planning and Review and Executive
Order 13563: Improving Regulations and Regulatory Review

    This action establishes SNURs for several new chemical substances
that were the subject of PMNs and TSCA section 5(e) Orders. The Office
of Management and Budget (OMB) has exempted these types of actions from
review under Executive Orders 12866 (58 FR 51735, October 4, 1993) and
13563 (76 FR 3821, January 21, 2011).

B. Paperwork Reduction Act (PRA)

    According to the PRA (44 U.S.C. 3501 et seq.), an agency may not
conduct or sponsor, and a person is not required to respond to a
collection of information that requires OMB approval under the PRA,
unless it has been approved by OMB and 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, are listed in
40 CFR part 9, and included on the related collection instrument or
form, if applicable. EPA is amending the table in 40 CFR part 9 to list
the OMB approval number for the information collection requirements
contained in this action. This listing of the OMB control numbers and
their subsequent codification in the CFR satisfies the display
requirements of PRA and OMB's implementing regulations at 5 CFR part
1320. This Information Collection Request (ICR) was previously subject
to public notice and comment prior to OMB approval, and given the
technical nature of the table, EPA finds that further notice and
comment to amend it is unnecessary. As a result, EPA finds that there
is ``good cause'' under section 553(b)(3)(B) of the Administrative
Procedure Act (5 U.S.C. 553(b)(3)(B)) to amend this table without
further notice and comment.
    The information collection activities in this action have already
been approved by OMB pursuant to the PRA under OMB control number 2070-
0012 (EPA ICR No. 574). This action does not impose any burden
requiring additional OMB approval. If an entity were to submit a SNUN
to the Agency, the annual burden is estimated to average between 30 and
170 hours per response. This burden estimate includes the time needed
to review instructions, search existing data sources, gather and
maintain the data needed, and complete, review, and submit the required
SNUN.
    Send any comments about the accuracy of the burden estimate, and
any suggested methods for minimizing respondent burden, including using
automated collection techniques, to the Director, Regulatory Support
Division, Office of Mission Support (2822T), Environmental Protection
Agency, 1200 Pennsylvania Ave. NW, Washington, DC 20460-0001. Please
remember to include the OMB control number in any correspondence, but
do not submit any completed forms to this address.

C. Regulatory Flexibility Act (RFA)

    Pursuant to RFA section 605(b) (5 U.S.C. 601 et seq.), the Agency
hereby certifies that promulgation of this SNUR will not have a
significant adverse economic impact on a substantial number of small
entities. The requirement to submit a SNUN applies to any person
(including small or large entities) who intends to engage in any
activity described in the final rule as a ``significant new use.''
Because these uses are ``new,'' based on all information currently
available to EPA, it appears that no small or large entities presently
engage in such activities. A SNUR requires that any person who intends
to engage in such activity in the future must first notify EPA by
submitting a SNUN. EPA's experience to date is that, in response to the
promulgation of SNURs covering over 1,000 chemicals, the Agency
receives only a small number of notices per year. For example, the
number of SNUNs received was seven in Federal fiscal year (FY) 2013, 13
in FY2014, six in FY2015, 10 in FY2016, 14 in FY2017, and 18 in FY2018
and only a fraction of these were from small businesses. In addition,
the Agency currently offers relief to qualifying small businesses by
reducing the SNUN submission fee from $16,000 to $2,800. This lower fee
reduces the total reporting and recordkeeping of cost of submitting a
SNUN to about $10,116 for qualifying small firms. Therefore, the
potential economic impacts of complying with this SNUR are not expected
to be significant or adversely impact a substantial number of small
entities. In a SNUR that published in the Federal Register of June 2,
1997 (62 FR 29684) (FRL-5597-1), the Agency presented its general
determination that final SNURs are not expected to have a significant
economic impact on a substantial number of small entities, which was
provided to the Chief Counsel for Advocacy of the Small Business
Administration.

D. Unfunded Mandates Reform Act (UMRA)

    Based on EPA's experience with proposing and finalizing SNURs,
State, local, and Tribal governments have not been impacted by these
rulemakings, and EPA does not have any reasons to believe that any
State, local, or Tribal government will be impacted by this action. As
such, EPA has determined that this action does not impose any
enforceable duty, contain any unfunded mandate, or otherwise have any
effect on small governments subject to the requirements of UMRA
sections 202, 203, 204, or 205 (2 U.S.C. 1501 et seq.).

E. Executive Order 13132: Federalism

    This action will not have a substantial direct effect 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 (64 FR 43255,
August 10, 1999).

F. Executive Order 13175: Consultation and Coordination With Indian
Tribal Governments

    This action does not have Tribal implications because it is not
expected to have substantial direct effects on Indian Tribes. This
action does not significantly nor uniquely affect the communities of
Indian Tribal governments, nor does it involve or impose any
requirements that affect Indian Tribes. Accordingly, the requirements
of Executive Order 13175 (65 FR 67249, November 9, 2000), do not apply
to this action.

G. Executive Order 13045: Protection of Children From Environmental
Health Risks and Safety Risks

    This action is not subject to Executive Order 13045 (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: Actions Concerning Regulations That
Significantly Affect Energy Supply, Distribution, or Use

    This action is not subject to Executive Order 13211 (66 FR 28355,
May 22, 2001), because this action is not expected to affect energy
supply, distribution, or use and because this action is not a
significant regulatory action under Executive Order 12866.

I. National Technology Transfer and Advancement Act (NTTAA)

    In addition, since this action does not involve any technical
standards, NTTAA section 12(d) (15 U.S.C. 272 note) does not apply to
this action.

J. Executive Order 12898: Federal Actions To Address Environmental
Justice in Minority Populations and Low-Income Populations

    This action does not entail special considerations of environmental
justice related issues as delineated by Executive Order 12898 (59 FR
7629, February 16, 1994).

XII. Congressional Review Act (CRA)

    Pursuant to the CRA (5 U.S.C. 801 et seq.), 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 action is not a ``major rule'' as defined by 5 U.S.C.
804(2).

List of Subjects

40 CFR Part 9

    Environmental protection, Reporting and recordkeeping requirements.

40 CFR Part 721

    Environmental protection, Chemicals, Hazardous substances,
Reporting and recordkeeping requirements.

    Dated: November 7, 2019.
Tala Henry,
Deputy Director, Office of Pollution Prevention and Toxics.
    Therefore, 40 CFR parts 9 and 721 are amended as follows:

PART 9--[AMENDED]

0
1. The authority citation for part 9 continues to read as follows:

    Authority: 7 U.S.C. 135 et seq., 136-136y; 15 U.S.C. 2001, 2003,
2005, 2006, 2601-2671; 21 U.S.C. 331j, 346a, 348; 31 U.S.C. 9701; 33
U.S.C. 1251 et seq., 1311, 1313d, 1314, 1318, 1321, 1326, 1330,
1342, 1344, 1345 (d) and (e), 1361; E.O. 11735, 38 FR 21243, 3 CFR,
1971-1975 Comp. p. 973; 42 U.S.C. 241, 242b, 243, 246, 300f, 300g,
300g-1, 300g-2, 300g-3, 300g-4, 300g-5, 300g-6, 300j-1, 300j-2,
300j-3, 300j-4, 300j-9, 1857 et seq., 6901-6992k, 7401-7671q, 7542,
9601-9657, 11023, 11048.

0
2. In Sec.  9.1, add Sec. Sec.  721.11149, 721.11151 through 721.11162,
and 721.11166 through 721.11172 in numerical order under the
undesignated center heading ``Significant New Uses of Chemical
Substances'' to read as follows:

Sec.  9.1  OMB approvals under the Paperwork Reduction Act.

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          40 CFR citation                      OMB control No.
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                                * * * * *
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               Significant New Uses of Chemical Substances
------------------------------------------------------------------------

                                * * * * *
                  721.11149                            2070-0012
                  721.11151                            2070-0012
                  721.11152                            2070-0012
                  721.11153                            2070-0012
                  721.11154                            2070-0012
                  721.11155                            2070-0012
                  721.11156                            2070-0012
                  721.11157                            2070-0012
                  721.11158                            2070-0012
                  721.11159                            2070-0012
                  721.11160                            2070-0012
                  721.11161                            2070-0012
                  721.11162                            2070-0012
                  721.11166                            2070-0012
                  721.11167                            2070-0012
                  721.11168                            2070-0012
                  721.11169                            2070-0012
                  721.11170                            2070-0012
                  721.11171                            2070-0012
                  721.11172                            2070-0012

                                * * * * *
------------------------------------------------------------------------

* * * * *

PART 721--[AMENDED]

0
3. The authority citation for part 721 continues to read as follows:

    Authority: 15 U.S.C. 2604, 2607, and 2625(c).

0
4. Add Sec. Sec.  721.11149 through 721.11172 to subpart E to read as
follows:

Subpart E--Significant New Uses for Specific Chemical Substances

* * * * *
Sec.
721.11149 Carbon nanomaterial (generic).
721.11150 [Reserved]
721.11151 2-Butanone 1,1,1,3,4,4,4-heptafluoro-3-(trifluoromethyl)-.
721.11152 Propanenitrile, 2,3,3,3 tetrafluoro-2-(trifluoromethyl)-.
721.11153 Polymeric sulfide (generic).
721.11154 Quaternary ammonium salts (generic).
721.11155 Alkyl methacrylates, polymer with olefins (generic).
721.11156 Hexanedioic acid, 1,6-bis(3,5,5-trimethylhexyl) ester.
721.11157 Alkylaminium hydroxide (generic).
721.11158 Polyamine polyacid adducts (generic).
721.11159 Aromatic isocyanate, polymer with alkyloxirane polymer
with oxirane ether with alkyldiol (2:l) and alkyloxirane polymer
with oxirane ether with alkyltriol (3:l) (generic).
721.11160 Aromatic isocyanate polymer with alkyloxirane,
alkyloxirane polymer with oxirane ether with alkanetriol and oxirane
(generic).
721.11161 Oils, hedychium flavescens.
721.11162 Siloxanes and silicones, cetyl Me, di-Me, Me 2-
(triethoxysilyl)ethyl.
721.11163-721.11165 [Reserved]
721.11166 1H-Benz[de] isoquinoline-1,3(2H)-dione-2-(alkyl)-
(alkylamino) (generic).
721.11167 Siloxanes and Silicones, di-Me, hydrogen-terminated,
reaction products with acrylic acid and 2-ethyl-2-[(2-propen-1-
yloxyl)methyl]-1,3-propanediol, polymers with chlorotrimethylsilane-
iso-Pr alc.-sodium silicate reaction products.
721.11168 2-Pentanone, 2,2',2''-[O,O',O''-
(ethenylsilylidyne)trioxime].
721.11169 2-Pentanone, 2,2',2''- [O,O',Oz''-
(methylsilylidyne)trioxime].
721.11170 Naphthalene trisulfonic acid sodium salt (generic).
721.11171 Polymer of aliphatic dicarboxylic acid and
dicycloalkaneamine (generic).
721.11172 Hexanedioic acid, polymer with trifunctional polyol, 1,1'-
methylenebis [isocyanatobenzene], and 2,2'-oxybis[ethanol]
(generic).
* * * * *

Sec.  721.11149  Carbon nanomaterial (generic).

    (a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as carbon
nanomaterial (PMN P-10-366) is subject to reporting under this section
for the significant new uses described in paragraph (a)(2) of this
section. The requirements of this section do not apply to quantities of
the substance after they have been reacted (cured), incorporated or
embedded into a polymer matrix that itself has been completely reacted
(cured), embedded in a permanent solid polymer, metal, glass, or
ceramic form, or completely embedded in an article as defined at 40 CFR
720.3(c).
    (2) The significant new uses are:

    (i) Protection in the workplace. Requirements as specified in Sec.
721.63(a)(1), (a)(2)(i) and (ii), (a)(3) through (5) (respirators must
provide a National Institute for Occupational Safety and Health
certified air purifying, tight-fitting full-face respirator equipped
with N-100, P-100, or R-100 filter with an Assigned Protection Factor
of at least 50), (a)(6) (particulate (including solids or liquid
droplets)), (when determining which persons are reasonable likely to be
exposed as required for Sec.  721.63(a)(1) and (4) engineering control
measures (e.g., enclosure or confinement of the operation, general and
local ventilation) or administrative control measures (e.g., workplace
policies and procedures) shall be considered and implemented to prevent
exposures, where feasible), and (c).
    (ii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec.  721.80(k), (l), (q), and (y)(1) (when the
substance is in liquid resin form). It is a significant new use to
process or use the powder form of the substance outside of the site of
manufacture or processing.
    (iii) Release to water. Requirements as specified in Sec.
721.90(a)(1), (b)(1), and (c)(1).
    (b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph (b).
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) through (e), (i), and (k) are applicable to manufacturers
and processors of this substance.
    (2) Limitations or revocation of certain notification requirements.
The provisions of Sec.  721.185 apply to this section.

Sec.  721.11150  [Reserved]

Sec.  721.11151  2-Butanone 1,1,1,3,4,4,4-heptafluoro-3-
(trifluoromethyl)-.

    (a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as 2-butanone
1,1,1,3,4,4,4-heptafluoro-3-(trifluoromethyl)- (PMN P-15-114, CAS No.
756-12-7) is subject to reporting under this section for the
significant new uses described in paragraph (a)(2) of this section. The
requirements of this section do not apply to quantities of the
substance after they have been reacted (cured).
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in Sec.
721.63(a)(1) through (3) (when determining which persons are reasonable
likely to be exposed as required for Sec.  721.63(a)(1), engineering
control measures (e.g., enclosure or confinement of the operation,
general and local ventilation) or administrative control measures
(e.g., workplace policies and procedures) shall be considered and
implemented to prevent exposures, where feasible), (b)(concentration
set at 1.0%), and (c).
    (ii) Hazard communication. Requirements as specified in Sec.
721.72(a) through (d), (f), (g)(1)(i), (g)(2)(i)(v), (g)(3)(ii)
(harmful to fish), (g)(4)(iii), and (g)(5). It is a significant new use
unless containers of the PMN substance are labeled with the statement:
``contains a dielectric fluid which should not be mixed or used in
conjunction with sulfur hexafluoride (SF6)''. Alternative hazard and
warning statements that meet the criteria of the Globally Harmonized
System and OSHA Hazard Communication Standard may be used.
    (iii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec.  721.80(t). It is a significant new use to use the
substance other than as a dielectric medium for medium and high voltage
power generation/distribution equipment and heat transfer.
    (iv) Release to water. Requirements as specified in Sec.
721.90(a)(4), (b)(4), and (c)(4) where N = 180.
    (b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph (b).
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) through (i) and (k) are applicable to manufacturers and
processors of this substance.
    (2) Limitations or revocation of certain notification requirements.
The provisions of Sec.  721.185 apply to this section.
    (3) Determining whether a specific use is subject to this section.
The provisions of Sec.  721.1725(b)(1) apply to paragraph (a)(2)(iii)
of this section.

Sec.  721.11152  Propanenitrile, 2,3,3,3 tetrafluoro-2-
(trifluoromethyl)-.

    (a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as propanenitrile,
2,3,3,3 tetrafluoro-2-(trifluoromethyl)- (PMN P-15-320, CAS No. 42532-
60-5) is subject to reporting under this section for the significant
new uses described in paragraph (a)(2) of this section. The
requirements of this section do not apply to quantities of the
substance after they have been reacted (cured).
    (2) The significant new uses are:
    (i) Hazard communication. Requirements as specified in Sec.
721.72(a) through (e) (concentration set at 1.0%), (f), and (g)(5). It
is a significant new use unless containers of the PMN substance are
labeled with the statement: ``contains a dielectric fluid which should
not be mixed or used in conjunction with sulfur hexafluoride (SF6)''.
Alternative hazard and warning statements that meet the criteria of the
Globally Harmonized System and OSHA Hazard Communication Standard may
be used.
    (ii) Industrial, commercial, and consumer activities. It is a
significant new use to use the substance other than as a dielectric
medium for medium and high voltage power generation and distribution
equipment.
    (b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph (b).
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) through (c) and (f) through (i) are applicable to
manufacturers and processors of this substance.
    (2) Limitations or revocation of certain notification requirements.
The provisions of Sec.  721.185 apply to this section.

Sec.  721.11153  Polymeric sulfide (generic).

    (a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
polymeric sulfide (PMN P-15-734) is subject to reporting under this
section for the significant new uses described in paragraph (a)(2) of
this section.
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in Sec.
721.63(a)(1), (a)(2)(i), (a)(3), (when determining which persons are
reasonable likely to be exposed as required for Sec.  721.63(a)(1),
engineering control measures (e.g., enclosure or confinement of the
operation, general and local ventilation) or administrative control
measures (e.g., workplace policies and procedures) shall be considered
and implemented to prevent exposures, where feasible), (b)
(concentration set at 1.0%), and (c).
    (ii) Hazard communication. Requirements as specified in Sec.
721.72(a) through (e)(concentration set at 1.0%), (f), (g)(1)(i), (vi),
and (ix) (neurotoxicity), (g)(2)(i), (iii), and (v), (g)(3)(i) and
(ii), and (g)(5). Alternative hazard and warning statements that meet
the criteria of the Globally Harmonized System and OSHA Hazard
Communication Standard may be used.
    (iii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec.  721.80(k) (wastewater heavy metal removal) and
(q). It is a

significant new use to manufacture, process, or use the substance in
any manner that results in inhalation exposure to workers.
    (iv) Release to water. Requirements as specified in Sec.
721.90(a)(4), (b)(4), and (c)(4) where N = 2.
    (b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph (b).
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) through (i) and (k) are applicable to manufacturers and
processors of this substance.
    (2) Limitations or revocation of certain notification requirements.
The provisions of Sec.  721.185 apply to this section.
    (3) Determining whether a specific use is subject to this section.
The provisions of Sec.  721.1725(b)(1) apply to paragraph (a)(2)(iii)
of this section.

Sec.  721.11154  Quaternary ammonium salts (generic).

    (a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substances identified generically as
quaternary ammonium salts (PMNs P-16-356 and P-16-357) are subject to
reporting under this section for the significant new uses described in
paragraph (a)(2) of this section. The requirements of this section do
not apply to quantities of the substances after they have been reacted
(cured).
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified Sec.
721.63(a)(1), (a)(2)(i), (a)(3), (when determining which persons are
reasonably likely to be exposed as required for Sec.  721.63(a)(1),
engineering control measures (e.g., enclosure or confinement of the
operation, general and local ventilation) or administrative control
measures (e.g., workplace policies and procedures) shall be considered
and implemented to prevent exposure where feasible), (b) (concentration
set at 1.0%), and (c).
    (ii) Hazard communication. Requirements as specified in Sec.
721.72(a) through (e) (concentration set at 1.0%), (f), (g)(1)(i) and
(ii) (neurotoxicity), (g)(2)(i), (iii), and (v), (g)(3)(i) and (ii),
and (g)(5). Alternative hazard and warning statements that meet the
criteria of the Globally Harmonized System and OSHA Hazard
Communication Standard may be used.
    (iii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec.  721.80(k). It is a significant new use to
manufacture, process, or use the substances in any manner way that
results in generation of a vapor, mist or aerosol.
    (b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph (b).
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) through (i) are applicable to manufacturers and processors
of these substances.
    (2) Limitations or revocation of certain notification requirements.
The provisions of Sec.  721.185 apply to this section.

Sec.  721.11155  Alkyl methacrylates, polymer with olefins (generic).

    (a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as alkyl
methacrylates, polymer with olefins (PMN P-16-375) is subject to
reporting under this section for the significant new uses described in
paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) Industrial, commercial, and consumer activities. Requirements
as specified in Sec.  721.80(f). It is a significant new use to import
the substance other than according to the confidential molecular weight
parameters specified in the TSCA Order for the substance.
    (ii) [Reserved]
    (b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph (b).
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) through (c) and (i) are applicable to manufacturers,
importers, and processors of this substance.
    (2) Limitations or revocation of certain notification requirements.
The provisions of Sec.  721.185 apply to this section.
    (3) Determining whether a specific use is subject to this section.
The provisions of Sec.  721.1725(b)(1) apply to paragraph (a)(2)(i) of
this section.

Sec.  721.11156  Hexanedioic acid, 1,6-bis(3,5,5-trimethylhexyl) ester.

    (a) Chemical substance and significant new uses subject to
reporting. (1) the chemical substance identified as hexanedioic acid,
1,6-bis(3,5,5-trimethylhexyl) ester (PMN P-16-386, CAS No. 20270-50-2)
is subject to reporting under this section for the significant new uses
described in paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in Sec.
721.63(a)(1) and (3), (when determining which persons are reasonably
likely to be exposed as required for Sec.  721.63(a)(1), engineering
control measures (e.g., enclosure or confinement of the operation,
general and local ventilation shall be considered and implemented to
prevent exposure, where feasible), (a)(6)(v) and (vi) (particulate
(including solids or liquid droplets)), (b) (concentration set at
1.0%), and (c).
    (ii) Hazard communication. Requirements as specified in Sec.
721.72(a) through (e) (concentration set at 1.0%), (f), (g)(1)(iii),
(iv), and (ix), (g)(2)(i), (ii), (iii), and (v), and (g)(5).
Alternative hazard and warning statements that meet the criteria of the
Globally Harmonized System and OSHA Hazard Communication Standard may
be used.
    (iii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec.  721.80(k) (motor oil formulations and gear oil
lubricants) and (p) (1,545,000 kilograms).
    (b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph (b).
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) through (i) are applicable to manufacturers and processors
of this substance.
    (2) Limitations or revocation of certain notification requirements.
The provisions of Sec.  721.185 apply to this section.

Sec.  721.11157  Alkylaminium hydroxide (generic).

    (a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
alkylaminium hydroxide (PMN P-16-396) is subject to reporting under
this section for the significant new uses described in paragraph (a)(2)
of this section.
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in Sec.
721.63(a)(1), (a)(2)(i), (ii), (iii), and (iv), (a)(3) (when
determining which persons are reasonably likely to be exposed as
required for Sec.  721.63(a)(1), engineering control measures (e.g.,
enclosure or confinement of the operation, general and local
ventilation) or administrative control measures (e.g., workplace
policies and procedures) shall be considered and implemented to prevent
exposures, where feasible), (b) (concentration set at 1.0%), and (c).
    (ii) Hazard communication. Requirements as specified in Sec.
721.71(a) through (e) (concentration set at 1.0%), (f), (g)(1)(i),
(ii), (iii), (vi), and (ix), (eye damage), (g)(2)(i), (ii), (iii), and
(v), and (g)(5). Alternative hazard and warning

statements that meet the criteria of the Globally Harmonized System and
OSHA Hazard Communication Standard may be used.
    (iii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec.  721.80(k), (q), (v)(1) and (2), (w)(1) and (2),
(x)(1) and (2), and (y)(1) and (2).
    (b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph (b).
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) through (i) are applicable to manufacturers and processors
of this substance.
    (2) Limitations or revocation of certain notification requirements.
The provisions of Sec.  721.185 apply to this section.
    (3) Determining whether a specific use is subject to this section.
The provisions of Sec.  721.1725(b)(1) apply to paragraph (a)(2)(iii)
of this section.

Sec.  721.11158  Polyamine polyacid adducts (generic).

    (a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substances identified generically as
polyamine polyacid adducts (PMNs P-16-572 and P-16-573) are subject to
reporting under this section for the significant new uses described in
paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) Industrial, commercial, and consumer activities. It is a
significant new to use to manufacture the substances in any manner
other than they are not amine terminated in order to maintain water
solubility levels below 1 part per billion.
    (ii) [Reserved]
    (b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph (b).
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) through (c) and (i) are applicable to manufacturers and
processors of these substances.
    (2) Limitations or revocation of certain notification requirements.
The provisions of Sec.  721.185 apply to this section.

Sec.  721.11159  Aromatic isocyanate, polymer with alkyloxirane polymer
with oxirane ether with alkyldiol (2:l) and alkyloxirane polymer with
oxirane ether with alkyltriol (3:l) (generic).

    (a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
aromatic isocyanate, polymer with alkyloxirane polymer with oxirane
ether with alkyldiol (2:l) and alkyloxirane polymer with oxirane ether
with alkyltriol (3:l) (PMN P-17-24) is subject to reporting under this
section for the significant new uses described in paragraph (a)(2) of
this section. The requirements of this section do not apply to
quantities of the substance after they have been reacted (cured).
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in Sec.
721.63(a)(1), (a)(2)(i) and (iv), (a)(3), (a)(6)(v) and (vi)
(particulate (including solids or liquid droplets)), (when determining
which persons are reasonable likely to be exposed as required for Sec.
721.63(a)(1), engineering control measures (e.g., enclosure or
confinement of the operation, general and local ventilation) or
administrative control measures (e.g., workplace policies and
procedures) shall be considered and implemented to prevent exposures,
where feasible), (b) (concentration set at 0.1%), and (c).
    (ii) Hazard communication. Requirements as specified in Sec.
721.72(a) through (e) (concentration set at 0.1%), (f), (g)(1)(i) and
(ii) (asthma), (g)(2)(i), (ii), (iii), and (v), and (g)(5). Alternative
hazard and warning statements that meet the criteria of the Globally
Harmonized System and OSHA Hazard Communication Standard may be used.
    (iii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec.  721.80(o). It is a significant new use to
manufacture, process, or use the substance in any manner that results
in generation of a vapor, dust, mist or aerosol. It is a significant
new use is manufacture, processing, or use of the PMN substance for
commercial purposes when the sealable goods or service could introduce
the chemical substance into consumer settings.
    (b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph (b).
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) through (i) are applicable to manufacturers and processors
of this substance.
    (2) Limitations or revocation of certain notification requirements.
The provisions of Sec.  721.185 apply to this section.

Sec.  721.11160  Aromatic isocyanate polymer with alkyloxirane,
alkyloxirane polymer with oxirane ether with alkanetriol and oxirane
(generic).

    (a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
aromatic isocyanate polymer with alkyloxirane, alkyloxirane polymer
with oxirane ether with alkanetriol and oxirane (PMN P-17-25) is
subject to reporting under this section for the significant new uses
described in paragraph (a)(2) of this section. The requirements of this
section do not apply to quantities of the substance after they have
been reacted (cured).
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in Sec.
721.63(a)(1), (a)(2)(i) and (iv), (a)(3), (a)(6)(v) and (vi),
(particulate (including solids or liquid droplets)), (when determining
which persons are reasonable likely to be exposed as required for Sec.
721.63(a)(1), engineering control measures (e.g., enclosure or
confinement of the operation, general and local ventilation) or
administrative control measures (e.g., workplace policies and
procedures) shall be considered and implemented to prevent exposures,
where feasible), (b) (concentration set at 0.1%), and (c).
    (ii) Hazard communication. Requirements as specified in Sec.
721.72(a) through (e) (concentration set at 0.1%), (f), (g)(1)(i) and
(ii) (asthma), (g)(2)(i), (ii), (iii), and (v), and (g)(5). Alternative
hazard and warning statements that meet the criteria of the Globally
Harmonized System and OSHA Hazard Communication Standard may be used.
    (iii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec.  721.80(o). It is a significant new use to
manufacture, process, or use the substance in any manner that results
in generation of a vapor, dust, mist or aerosol. It is a significant
new use is manufacture, processing, or use of the PMN substance for
commercial purposes when the sealable goods or service could introduce
the chemical substance into consumer settings.
    (b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph (b).
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) through (i) are applicable to manufacturers and processors
of this substance.
    (2) Limitations or revocation of certain notification requirements.
The provisions of Sec.  721.185 apply to this section.

Sec.  721.11161   Oils, hedychium flavescens.

    (a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as oils, hedychium
flavescens, (PMN P-17-148, CAS No. 1902936-65-5) is subject to
reporting under this section for the significant new uses described in
paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in Sec.
721.63(a)(1), (a)(2)(i), (iii), and (iv), (a)(3), (a)(4) (when
determining which persons are reasonably likely to be exposed as
required for Sec.  721.63(a)(1) and (4), engineering control measures
(e.g., enclosure or confinement of the operation, general and local
ventilation) or administrative control measures (e.g., workplace
policies and procedures) shall be considered and implemented to prevent
exposure, where feasible), (a)(5) (respirators must provide a National
Institute for Occupational Safety and Health (NIOSH) assigned
protection factor of at least 50), (a)(6)(v) and (vi), (b)
(concentration set at 1.0%), and (c).
    (ii) Hazard communication. Requirements as specified in Sec.
721.72(a) through (d), (f), (g)(1)(iv), (vi), (vii), and (ix)
(respiratory sensitization), (g)(2)(i), (ii), (iii), (iv), and (v), and
(g)(5). Alternative hazard and warning statements that meet the
criteria of the Globally Harmonized System and OSHA Hazard
Communication Standard may be used.
    (iii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec.  721.80(f), (k) (odoriferous component of
fragrance compounds) and (s) (70 kilograms). It is a significant new
use to manufacture, process, or use the substance in any manner that
generates a mist or aerosol.
    (b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph (b).
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) through (i) are applicable to manufacturers and processors
of this substance.
    (2) Limitations or revocation of certain notification requirements.
The provisions of Sec.  721.185 apply to this section.

Sec.  721.11162  Siloxanes and silicones, cetyl Me, di-Me, Me 2-
(triethoxysilyl)ethyl.

    (a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as siloxanes and
silicones, cetyl Me, di-Me, Me 2-(triethoxysilyl)ethyl (PMN P-17-174,
CAS No. 1887149-13-4) is subject to reporting under this section for
the significant new uses described in paragraph (a)(2) of this section.
The requirements of this section do not apply to quantities of the
substance after they have been reacted (cured).
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in Sec.
721.63(a)(1), (a)(2)(i), (a)(3) (when determining which persons are
reasonable likely to be exposed as required for Sec.  721.63(a)(1),
engineering control measures (e.g., enclosure or confinement of the
operation, general and local ventilation) or administrative control
measures (e.g., workplace policies and procedures) shall be considered
and implemented to prevent exposures, where feasible), and (c).
    (ii) Hazard communication. Requirements as specified in Sec.
721.72(a) through (e) (concentration set at 1.0%), (f), (g)(1)(i) and
(ix) (neurotoxicity), (g)(2)(i) and (v), and (g)(5). Alternative hazard
and warning statements that meet the criteria of the Globally
Harmonized System and OSHA Hazard Communication Standard may be used.
    (iii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec.  721.80(f) and (q). It is a significant new use to
manufacture or use the substance in any manner that results in
generation of a vapor, mist or aerosol.
    (b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph (b).
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) through (i) are applicable to manufacturers and processors
of this substance.
    (2) Limitations or revocation of certain notification requirements.
The provisions of Sec.  721.185 apply to this section.
    (3) Determining whether a specific use is subject to this section.
The provisions of Sec.  721.1725(b)(1) apply to paragraph (a)(2)(iii)
of this section.

Sec. Sec.  721.11163-721.11165  [Reserved]

Sec.  721.11166  1H-Benz[de] isoquinoline-1,3(2H)-dione-2-(alkyl)-
(alkylamino) (generic).

    (a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as 1H-
benz[de] isoquinoline-1,3(2H)-dione-2-(alkyl)-(alkylamino) (PMN P-17-
251) is subject to reporting under this section for the significant new
uses described in paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in Sec.
721.63(a)(1), (a)(2)(i), (iii), and (iv), (a)(3), (when determining
which persons are reasonably likely to be exposed as required as Sec.
721.63(a)(1) engineering control measures (e.g., enclosure or
confinement of the operation, general and local ventilation shall be
considered and implemented to prevent exposure, where feasible),
(a)(6)(v) and (vi) (particulate (including solids or liquid droplets)),
and (c).
    (ii) Hazard communication. Requirements as specified in Sec.
721.72(a) through (d), (f), (g)(1) (acute toxicity, mutagenicity, eye
irritation), (g)(2)(i), (ii), and (v), and (g)(5). Alternative hazard
and warning statements that meet the criteria of the Globally
Harmonized System and OSHA Hazard Communication Standard may be used.
    (iii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec.  721.80(f). It is a significant new use to import,
process, or use the PMN substance at a concentration greater than 0.4%.
    (b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph (b).
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) through (i) are applicable to manufacturers and processors
of this substance.
    (2) Limitations or revocation of certain notification requirements.
The provisions of Sec.  721.185 apply to this section.

Sec.  721.11167  Siloxanes and Silicones, di-Me, hydrogen-terminated,
reaction products with acrylic acid and 2-ethyl-2-[(2-propen-1-
yloxyl)methyl]-1,3-propanediol, polymers with chlorotrimethylsilane-
iso-Pr alc.-sodium silicate reaction products.

    (a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as siloxanes and
silicones, di-Me, hydrogen-terminated, reaction products with acrylic
acid and 2-ethyl-2-[(2-propen-1-yloxyl)methyl]-1,3-propanediol,
polymers with chlorotrimethylsilane-iso-Pr alc.-sodium silicate
reaction products (PMN P-17-296, CAS No. 2014386-23-1) is subject to
reporting under this section for the significant new uses described in
paragraph (a)(2) of this section. The requirements of this section do
not apply to quantities of the PMN substance after they have been
completely reacted (cured).
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in Sec.
721.63(a)(1), (a)(2)(i) through (iii), (a)(3) through (5) (respirators
must

provide a National Institute for Occupational Safety and Health
assigned protection factor of at least 1,000 and are required for any
process generating a spray, mist, or aerosol), (when determining which
persons are reasonable likely to be exposed as required for Sec.
721.63(a)(1), engineering control measures (e.g., enclosure or
confinement of the operation, general and local ventilation) or
administrative control measures (e.g., workplace policies and
procedures) shall be considered and implemented to prevent exposures,
where feasible), (a)(6)(v) and (vi) (particulate (including solids or
liquid droplets)), (b) (concentration set at 1.0%), and (c).
    (ii) Hazard communication. Requirements as specified in Sec.
721.72(a) through (e) (concentration set at 1.0%), (f), (g)(1)(i),
(sensitization) (iv), (vii), and (ix), (g)(2)(i), (ii), (iii), (iv),
and (v), and (g)(5). Alternative hazard and warning statements that
meet the criteria of the Globally Harmonized System and OSHA Hazard
Communication Standard may be used.
    (iii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec.  721.80(f).
    (b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph (b).
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) through (i) are applicable to manufacturers and processors
of this substance.
    (2) Limitations or revocation of certain notification requirements.
The provisions of Sec.  721.185 apply to this section.

Sec.  721.11168  2-Pentanone, 2,2',2''-[O,O',O''-
(ethenylsilylidyne)trioxime].

    (a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as 2-pentanone,
2,2',2''-[O,O',O''-(ethenylsilylidyne)trioxime] (PMN P-17-308, CAS No.
58190-62-8) is subject to reporting under this section for the
significant new uses described in paragraph (a)(2) of this section. The
requirements of this section do not apply to quantities of the
substance after they have been completely reacted (cured).
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in Sec.
721.63(a)(1), (a)(2)(i), (a)(3) (when determining which persons are
reasonably likely to be exposed as required for Sec.  721.63(a)(1),
engineering control measures (e.g., enclosure or confinement of the
operation, general and local ventilation) or administrative control
measures (e.g., workplace policies and procedures) shall be considered
and implemented to prevent exposure, where feasible), (b)
(concentration set at 1.0%), and (c).
    (ii) Hazard communication. Requirements as specified in Sec.
721.72(a) through (e) (concentration set at 1.0%), (f), (g)(1)(i),
(iii), (iv), (vi), (vii), (viii), and (ix), (g)(2)(i), (iii), and (v),
and (g)(5). Alternative hazard and warning statements that meet the
criteria of the Globally Harmonized System, and OSHA Hazard
Communication Standard may be used.
    (iii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec.  721.80(f) and (q). It is a significant new use to
process or use the substance involving a method that generates a vapor,
mist, or aerosol.
    (b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph (b).
    (1) Recordkeeping. Recordkeeping as specified in Sec.  721.125(a)
through (i) are applicable to manufacturers and processors of this
substance.
    (2) Limitations or revocation of certain notification requirements.
The provisions of Sec.  721.185 apply to this section.
    (3) Determining whether a specific use is subject to this section.
The provisions of Sec.  721.1725(b)(1) apply to paragraph (a)(2)(iii)
of this section.

Sec.  721.11169  2-Pentanone, 2,2',2''- [O,O',O''-
(methylsilylidyne)trioxime].

    (a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as 2-pentanone,
2,2',2''- [O,O',O''-(methylsilylidyne)trioxime] (PMN P-17-309, CAS No.
37859-55-5) is subject to reporting under this section for the
significant new uses described in paragraph (a)(2) of this section. The
requirements of this section do not apply to quantities of the
substance after they have been completely reacted (cured).
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in Sec.
721.63(a)(1), (a)(2)(i), (a)(3) (when determining which persons are
reasonably likely to be exposed as required for Sec.  721.63(a)(1),
engineering control measures (e.g., enclosure or confinement of the
operation, general and local ventilation) or administrative control
measures (e.g., workplace policies and procedures) shall be considered
and implemented to prevent exposure, where feasible), (b)
(concentration set at 1.0%), and (c).
    (ii) Hazard communication. Requirements as specified in Sec.
721.72(a) through (e) (concentration set at 1.0%), (f), (g)(1)(i),
(iii), (iv), (vi), (vii), (viii), and (ix), (g)(2)(i), (iii), and (v),
and (g)(5). Alternative hazard and warning statements that meet the
criteria of the Globally Harmonized System, and OSHA Hazard
Communication Standard may be used.
    (iii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec.  721.80(f) and (q). It is a significant new use to
process or use the substance involving a method that generates a vapor,
mist, or aerosol.
    (b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph (b).
    (1) Recordkeeping. Recordkeeping as specified in Sec.  721.125(a)
through (i) are applicable to manufacturers and processors of this
substance.
    (2) Limitations or revocation of certain notification requirements.
The provisions of Sec.  721.185 apply to this section.
    (3) Determining whether a specific use is subject to this section.
The provisions of Sec.  721.1725(b)(1) apply to paragraph (a)(2)(iii)
of this section.

Sec.  721.11170  Naphthalene trisulfonic acid sodium salt (generic).

    (a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
naphthalene trisulfonic acid sodium salt (PMN P-17-321) is subject to
reporting under this section for the significant new uses described in
paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in Sec.
721.63(a)(1), (a)(2)(i) and (iv), (a)(3) through (5) (respirators must
provide a National Institute for Occupational Safety and Health
assigned protection factor of at least 50), (when determining which
persons are reasonable likely to be exposed as required for Sec.
721.63(a)(1), engineering control measures (e.g., enclosure or
confinement of the operation, general and local ventilation) or
administrative control measures (e.g., workplace policies and
procedures) shall be considered and implemented to prevent exposures,
where feasible), (b) (concentration set at 1.0%), and (c).
    (ii) Hazard communication. Requirements as specified in Sec.
721.72(a) through (e) (concentration set at 1.0%), (f), (g)(1)(i),
(ii), (iv), and (ix), (g)(2)(i) through (v), and (g)(5). Alternative
hazard and warning statements that meet the criteria of the Globally

Harmonized System and OSHA Hazard Communication Standard may be used.
    (iii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec.  721.80(q) and (t). It is a significant new use to
manufacture, process, or use the substance in any manner that generates
a vapor, mist, or aerosol.
    (b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph (b).
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) through (i) are applicable to manufacturers and processors
of this substance.
    (2) Limitations or revocation of certain notification requirements.
The provisions of Sec.  721.185 apply to this section.
    (3) Determining whether a specific use is subject to this section.
The provisions of Sec.  721.1725(b)(1) apply to paragraph (a)(2)(iii)
of this section.

Sec.  721.11171   Polymer of aliphatic dicarboxylic acid and
dicycloalkaneamine (generic).

    (a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as polymer
of aliphatic dicarboxylic acid and dicycloalkaneamine (PMN P-17-327) is
subject to reporting under this section for the significant new uses
described in paragraph (a)(2) of this section. The requirements of this
section do not apply to quantities of the substance after they have
been reacted (cured).
    (2) The significant new uses are:
    (i) Industrial, commercial, and consumer activities. It is a
significant new use to manufacture (includes import) the substance to
have an average molecular weight of greater than 10,000 Daltons.
    (ii) [Reserved]
    (b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph (b).
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) through (c) and (i) are applicable to manufacturers and
processors of this substance.
    (2) Limitations or revocation of certain notification requirements.
The provisions of Sec.  721.185 apply to this section.

Sec.  721.11172  Hexanedioic acid, polymer with trifunctional polyol,
1,1'-methylenebis [isocyanatobenzene], and 2,2'-oxybis[ethanol]
(generic).

    (a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
hexanedioic acid, polymer with trifunctional polyol, 1,1'-methylenebis
[isocyanatobenzene], and 2,2'-oxybis[ethanol] (PMN P-17-330) is subject
to reporting under this section for the significant new uses described
in paragraph (a)(2) of this section. The requirements of this section
do not apply to quantities of the substance after they have been
reacted (cured).
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in Sec.
721.63(a)(1), (a)(2)(i) through (iv), (a)(3) (when determining which
persons are reasonable likely to be exposed as required for Sec.
721.63(a)(1), engineering control measures (e.g., enclosure or
confinement of the operation, general and local ventilation) or
administrative control measures (e.g., workplace policies and
procedures) shall be considered and implemented to prevent exposures,
where feasible), and (c).
    (ii) Hazard communication. Requirements as specified in Sec.
721.72(a) through (d), (f), (g)(1)(i) (eye and respiratory irritation),
(g)(2)(i) through (iii) and (v), and (g)(5). Alternative hazard and
warning statements that meet the criteria of the Globally Harmonized
System and OSHA Hazard Communication Standard may be used.
    (iii) Industrial, commercial, and consumer activities. It is a
significant new use to manufacture, process, or use the substance for
consumer use or for commercial uses that could introduce the substance
into a consumer setting. It is a significant new use to manufacture,
process, or use the substance in any manner that generates a dust,
mist, or aerosol.
    (b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph (b).
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) through (i) are applicable to manufacturers and processors
of this substance.
    (2) Limitations or revocation of certain notification requirements.
The provisions of Sec.  721.185 apply to this section.

[FR Doc. 2019-24946 Filed 11-22-19; 8:45 am]
 BILLING CODE 6560-50-P


Paul Lewis 05/ 27/ 2004 01: 52 PM To: Susie Wilcher/ DC/ USEPA/ US@ EPA cc: Subject: RE: May 7 Voice mail Susie,

Here is the email from Dennis Morgan as you requested. Thanks.

Paul Paul Lewis FIFRA Scientific Advisory Panel United States Environmental Protection Agency 202 564 8381 lewis. paul@ epa. gov  Forwarded by Paul Lewis/ DC/ USEPA/ US on 05/ 27/ 2004 01: 53 PM  Dennis Morgan < dennis_ morgan@ msn. com> 05/ 20/ 2004 11: 44 AM To: Lewis. Paul@ epamail. epa. gov cc: Dorsey. Larry@ epamail. epa. gov Subject: RE: May 7 Voice mail Dear Mr. Lewis;

I apologize for the delay in responding to you, I have been out of the country and could not access my email accounts. As you have seen in the email traffic between Jack Housenger and myself, there is a lack of concurrence on what the panel said and why the said it regarding the use of an uncertainty factor less than 1. I would like you to send the attached email thread to the panel so the panel has a clear understanding of what the Antimicrobial Division thinks they have heard. The panel then will have an opportunity to address that specific area of ambiguity in the written report.

Dennis Morgan Forest Products Research Laboratory LLC Tel: 541 484 9477 Fax: 541 484 5881 Mob: 541 954 6849  Original Message From: Lewis. Paul@ epamail. epa. gov [ mailto: Lewis. Paul@ epamail. epa. gov] Sent: Friday, May 14, 2004 12: 36 PM To: Dennis Morgan; Housenger. Jack@ epamail. epa. gov; Jim Aidala; Kipp Coddington; Lynn Bergeson; Leighton. Timothy@ epamail. epa. gov; Dorsey. Larry@ epamail. epa. gov Subject: RE: May 7 Voice mail Dear Mr. Morgan,

Thank you for your note concerning the FIFRA SAP's deliberations at its May 4 6, 2004 meeting. As you know, the Panel is currently preparing its meeting minutes, summarizing their recommendations at the meeting. If you have additional comments you desire to share with the Panel, please provide them to me and they will be distributed to both the Panel and the public via the EPA, Office of Pesticide Program docket. However, please be advised that it is the Panel's discretion to consider such materials since the FIFRA SAP meeting has ended.

Sincerely,

Paul Lewis Paul Lewis FIFRA Scientific Advisory Panel United States Environmental Protection Agency 202 564 8381 lewis. paul@ epa. gov Larry Dorsey To: Jack Housenger/ DC/ USEPA/ US@ EPA 05/ 14/ 2004 09: 15 cc: Dennis Morgan < dennis_ morgan@ msn. com>, Jim Aidala < jaidala@ lawbc. com>, Kipp AM Coddington < KCoddington@ alston. com>, Lynn Bergeson < lbergeson@ lawbc. com>, Paul Lewis/ DC/ USEPA/ US@ EPA, Timothy Leighton/ DC/ USEPA/ US@ EPA Subject: RE: May 7 Voice mail( Document link: Paul Lewis)

Good Morning. The report will capture what was discussed, decided, and recommended by the panel at the meeting. I would like to stress that this is an independent peer review panel. As part of our process, after a meeting has concluded, individuals can submit additional materials to the panel through the DFO ( Paul Lewis). These materials will distributed to the panel and the public docket. It is at the panels discretion to use materials submitted after a meeting. In some cases, materials have been requested by the panel at a meeting and these materials have been submitted to the panel to be used by the panel in the drafting of the report. These materials are generally for points of clarification for the panel.

I certainly hope that everyone will respect this process and not compromise the independence of the panel members in the drafting of the meeting report.

Jack Housenger To: Dennis Morgan < dennis_ morgan@ msn. com> 05/ 13/ 2004 07: 38 cc: Jim Aidala < jaidala@ lawbc. com>, Kipp Coddington < KCoddington@ alston. com>, Lynn PM Bergeson < lbergeson@ lawbc. com>, Larry Dorsey/ DC/ USEPA/ US@ EPA, Paul Lewis/ DC/ USEPA/ US@ EPA, Timothy Leighton/ DC/ USEPA/ US@ EPA Subject: RE: May 7 Voice mail( Document link: Larry Dorsey)

Denny, I don't think that is necessary they should be writting the final report as clearly as they can Paul and Larry will ensure that they do so Jack E. Housenger, Associate Director Antimicrobials Division Office of Pesticide Programs 703 308 8163 Visit: http:// www. epa. gov/ pesticides/

Dennis Morgan < dennis_ morgan@ ms To: Jack Housenger/ DC/ USEPA/ US@ EPA n. com> cc: Lynn Bergeson < lbergeson@ lawbc. com>, Jim Aidala < jaidala@ lawbc. com>, Kipp Coddington < KCoddington@ alston. com>

05/ 12/ 2004 11: 17 Subject: RE: May 7 Voice mail AM Jack;

I realize that you and your team are busy, and I do appreciate your responses. Would it help if I forwarded this e mail thread to Dr. Menne, Dr. Foulds and Dr. Pleus so they can be aware of the confusion and hopefully address these issues in the written report?

Denny  Original Message From: Housenger. Jack@ epamail. epa. gov [ mailto: Housenger. Jack@ epamail. epa. gov]

Sent: Wednesday, May 12, 2004 4: 36 AM To: Dennis Morgan Cc: Susy Hazen; Jim Aidala; Kipp Coddington; Lynn Bergeson; Jones. Jim@ epamail. epa. gov; Sanders. Frank@ epamail. epa. gov; Chen. Jonathan@ epamail. epa. gov; McMahon. Tim@ epamail. epa. gov; Cook. Norm@ epamail. epa. gov; Leighton. Timothy@ epamail. epa. gov; Dang. Winston@ epamail. epa. gov Subject: Re: May 7 Voice mail Denny, I didn't want you to think I was not going to respond to your email. We were offsite yesterday at an all day retreat. First let me say that I think we were very happy to get the guidance that we got from the SAP and to also to get it in real time. Having said this, what the SAP actually said specifically won't be certain until the final report comes out which is what I was attempting to say in my voice mail to you. Although we have a good idea, I think you said it best in your email that perhaps we heard something different because of our differing involvements. The final report will have recommendations that will be put onto paper and give us clear guidance as well as justifications. We typically take the panel's recommendations and then decide what our position is. As Lynn points out, we are under no legal obligation to accept the recommendations, however, as we talked about earlier, these are the experts that we assembled to give us guidance and we would approach this with that in mind. Until we get their report in writing; however, I don't feel comfortable saying definitively that a certain value with all the uncertainty factors accounted for is where the Agency is going to end up and having you conduct a study based on that level. I'd be happy to discuss this with you further if you'd like to.

Jack E. Housenger, Associate Director Antimicrobials Division Office of Pesticide Programs 703 308 8163 Visit: http:// www. epa. gov/ pesticides/

Dennis Morgan < dennis_ morgan@ ms To: Jack Housenger < housenger. jack@ epamail. epa. gov> n. com> cc: Lynn Bergeson < lbergeson@ lawbc. com>, Susy Hazen < hazen. susan@ epamail. epa. gov>, Jim Aidala 05/ 10/ 2004 11: 45 < jaidala@ lawbc. com>, Kipp Coddington AM < KCoddington@ alston. com>

Subject: May 7 Voice mail Jack;

Thanks for leaving the voice mail on my cell, Friday at 5: 00 p. m. EDT. I was in the air between Baltimore and Denver. Lynn had told me after our March 3 meeting that the EPA was not under any legal requirement to follow the recommendations of the SAP. You and I had already discussed that issue in a previous phone call and I recall you saying that it would be very difficult for the agency not to follow the recommendations the SAP. I would like to remind you that it was your management that called for this SAP to see if they could get a conclusive answer to the dermal sensitization issue regarding our ACC application.

I understand what you believe you heard regarding the uncertainty factor less than one. Perhaps because of my involvement with the development of our presentation I heard something different than you did. I heard that for dermal sensitization the test vehicle has to match the exposure vehicle or there should be use of uncertainty factors from less than one to a value greater than one. Some examples, that I heard the panel mention were LLNA test vehicle or DMSO when the exposure is via water or human sweat then a value less than one should be used by the EPA because DMSO is a strong skin penetrant when compared to water or human sweat. A converse would be if a wood preservative were applied in DMSO and the test vehicle for the LLNA was 1 % L92 then based on the data presented the UF should be at least 2 or greater.

For patch testing, Dr. Menne reported in the meeting that occluded patch testing was a much more severe testing environment than the open exposure expected from treated wood. There are several reports in the literature that support this position. The SAP recommended an UF of 0.1 in this case because of the large body of evidence in the literature that Dr. Menne and Dr. Foulds were aware of that show at least a 10 fold difference in dose between occluded and open testing for the same hapten including hexavalent chromium.

I would submit to you that based on our Jan. 28 meeting and again on Jim Jones comments on Mar. 3, in that the agency is concerned about causing induction in the general population and wants to know about the impact on the sensitive population that the range of endpoints given by the SAP ( 0.3 to 0.09 ug/ cm2) is below the levels that would be protective of the general population for the prevention of induction.

I am concern that the EPA did not like what the heard last week, and is now preparing to ignore the recommendations of the SAP, because the SAP did not agree with the EPA's position prior to the SAP.

Dennis Morgan Forest Products Research Laboratory LLC Tel: 541 484 9477 Fax: 541 484 5881 Mob: 541 954 6849  Message from " Dennis Morgan" < dennis_ morgan@ msn. com> on Fri, 14 May 2004 09: 52: 53  0700  To: < Housenger. Jack@ epamail. epa. gov> cc: "' Jim Aidala'" < jaidala@ lawbc. com>, "' Kipp Coddington'" < KCoddington@ alston. com>, "' Lynn Bergeson'" < lbergeson@ lawbc. com>, < Dorsey. Larry@ epamail. epa. gov>, < Lewis. Paul@ epamail. epa. gov>, < Leighton. Timothy@ epamail. epa. gov> Subject: RE: May 7 Voice mail Jack; I think that your decision not to ask the panel to clarify, what is obviously, a central point in their presentation and a point that you are well aware has a significant impact on the ACC registration is unfortunate. You, clearly have an opportunity here to have a very specific question answered by the leading scientist in this specific discipline, why not take advantage of it? I will be very disappointed, if the agency does not ask for clarification on this issue, then uses the lack of clarity, to support the use of a surface area endpoint, that is below the range the panel suggested.

As you know, ( see Nader's email) that the agency is already deferring the decision on the endpoint for the wipe test until the final written report. Base on the phone calls and emails from you, I believe that the AD has not heard the message for the SAP ( that chrome on the surface of wood is not an issue), and will continue to support, some version of the ADTC value, which was thoroughly dismissed by the panel. Jack, I am sure that the AD has better things to do than try to support an endpoint, that was drafted by staff, who in your own words were not very knowledgeable in the subject matter, that is not supported by the science or the advisory panel EPA brought together to review the endpoint and the methods that were used to generate the endpoint.  Original Message From: Housenger. Jack@ epamail. epa. gov [ mailto: Housenger. Jack@ epamail. epa. gov] Sent: Thursday, May 13, 2004 4: 39 PM To: Dennis Morgan Cc: Jim Aidala; Kipp Coddington; Lynn Bergeson; Dorsey. Larry@ epamail. epa. gov; Lewis. Paul@ epamail. epa. gov; Leighton. Timothy@ epamail. epa. gov Subject: RE: May 7 Voice mail Denny, I don't think that is necessary they should be writting the final report as clearly as they can Paul and Larry will ensure that they do so Jack E. Housenger, Associate Director Antimicrobials Division Office of Pesticide Programs 703 308 8163 Visit: http:// www. epa. gov/ pesticides/

Dennis Morgan < dennis_ morgan@ ms To: Jack Housenger/ DC/ USEPA/ US@ EPA n. com> cc: Lynn Bergeson < lbergeson@ lawbc. com>, Jim Aidala < jaidala@ lawbc. com>, Kipp Coddington 05/ 12/ 2004 11: 17 < KCoddington@ alston. com> AM Subject: RE: May 7 Voice mail Jack; I realize that you and your team are busy, and I do appreciate your responses. Would it help if I forwarded this e mail thread to Dr. Menne, Dr. Foulds and Dr. Pleus so they can be aware of the confusion and hopefully address these issues in the written report?

Denny  Original Message From: Housenger. Jack@ epamail. epa. gov [ mailto: Housenger. Jack@ epamail. epa. gov] Sent: Wednesday, May 12, 2004 4: 36 AM To: Dennis Morgan Cc: Susy Hazen; Jim Aidala; Kipp Coddington; Lynn Bergeson; Jones. Jim@ epamail. epa. gov; Sanders. Frank@ epamail. epa. gov; Chen. Jonathan@ epamail. epa. gov; McMahon. Tim@ epamail. epa. gov; Cook. Norm@ epamail. epa. gov; Leighton. Timothy@ epamail. epa. gov; Dang. Winston@ epamail. epa. gov Subject: Re: May 7 Voice mail Denny, I didn't want you to think I was not going to respond to your email. We were offsite yesterday at an all day retreat. First let me say that I think we were very happy to get the guidance that we got from the SAP and to also to get it in real time. Having said this, what the SAP actually said specifically won't be certain until the final report comes out which is what I was attempting to say in my voice mail to you. Although we have a good idea, I think you said it best in your email that perhaps we heard something different because of our differing involvements. The final report will have recommendations that will be put onto paper and give us clear guidance as well as justifications. We typically take the panel's recommendations and then decide what our position is. As Lynn points out, we are under no legal obligation to accept the recommendations, however, as we talked about earlier, these are the experts that we assembled to give us guidance and we would approach this with that in mind. Until we get their report in writing; however, I don't feel comfortable saying definitively that a certain value with all the uncertainty factors accounted for is where the Agency is going to end up and having you conduct a study based on that level. I'd be happy to discuss this with you further if you'd like to.

Jack E. Housenger, Associate Director Antimicrobials Division Office of Pesticide Programs 703 308 8163 Visit: http:// www. epa. gov/ pesticides/

Dennis Morgan < dennis_ morgan@ ms To: Jack Housenger < housenger. jack@ epamail. epa. gov> n. com> cc: Lynn Bergeson < lbergeson@ lawbc. com>, Susy Hazen < hazen. susan@ epamail. epa. gov>, Jim Aidala 05/ 10/ 2004 11: 45 < jaidala@ lawbc. com>, Kipp Coddington AM < KCoddington@ alston. com> Subject: May 7 Voice mail Jack; Thanks for leaving the voice mail on my cell, Friday at 5: 00 p. m. EDT. I was in the air between Baltimore and Denver. Lynn had told me after our March 3 meeting that the EPA was not under any legal requirement to follow the recommendations of the SAP. You and I had already discussed that issue in a previous phone call and I recall you saying that it would be very difficult for the agency not to follow the recommendations the SAP. I would like to remind you that it was your management that called for this SAP to see if they could get a conclusive answer to the dermal sensitization issue regarding our ACC application. I understand what you believe you heard regarding the uncertainty factor less than one. Perhaps because of my involvement with the development of our presentation I heard something different than you did. I heard that for dermal sensitization the test vehicle has to match the exposure vehicle or there should be use of uncertainty factors from less than one to a value greater than one. Some examples, that I heard the panel mention were LLNA test vehicle or DMSO when the exposure is via water or human sweat then a value less than one should be used by the EPA because DMSO is a strong skin penetrant when compared to water or human sweat. A converse would be if a wood preservative were applied in DMSO and the test vehicle for the LLNA was 1 % L92 then based on the data presented the UF should be at least 2 or greater. For patch testing, Dr. Menne reported in the meeting that occluded patch testing was a much more severe testing environment than the open exposure expected from treated wood. There are several reports in the literature that support this position. The SAP recommended an UF of 0.1 in this case because of the large body of evidence in the literature that Dr. Menne and Dr. Foulds were aware of that show at least a 10 fold difference in dose between occluded and open testing for the same hapten including hexavalent chromium.

I would submit to you that based on our Jan. 28 meeting and again on Jim Jones comments on Mar. 3, in that the agency is concerned about causing induction in the general population and wants to know about the impact on the sensitive population that the range of endpoints given by the SAP ( 0.3 to 0.09 ug/ cm2) is below the levels that would be protective of the general population for the prevention of induction. I am concern that the EPA did not like what the heard last week, and is now preparing to ignore the recommendations of the SAP, because the SAP did not agree with the EPA's position prior to the SAP. Dennis Morgan Forest Products Research Laboratory LLC Tel: 541 484 9477 Fax: 541 484 5881 Mob: 541 954 6849


CA Codes (WATER CODE)

SECTION 13142.5

13142.5.  In addition to any other policies established pursuant to

this division, the policies of the state with respect to water

quality as it relates to the coastal marine environment are that:

   (a) Wastewater discharges shall be treated to protect present and

future beneficial uses, and, where feasible, to restore past

beneficial uses of the receiving waters.  Highest priority shall be

given to improving or eliminating discharges that adversely affect

any of the following:

   (1) Wetlands, estuaries, and other biologically sensitive sites.

   (2) Areas important for water contact sports.

   (3) Areas that produce shellfish for human consumption.

   (4) Ocean areas subject to massive waste discharge.

   Ocean chemistry and mixing processes, marine life conditions,

other present or proposed outfalls in the vicinity, and relevant

aspects of areawide waste treatment management plans and programs,

but not of convenience to the discharger, shall for the purposes of

this section, be considered in determining the effects of such

discharges.  Toxic and hard-to-treat substances should be pretreated

at the source if such substances would be incompatible with effective

and economical treatment in municipal treatment plants.

   (b) For each new or expanded coastal powerplant or other

industrial installation using seawater for cooling, heating, or

industrial processing, the best available site, design, technology,

and mitigation measures feasible shall be used to minimize the intake

and mortality of all forms of marine life.

   (c) Where otherwise permitted, new warmed or cooled water

discharges into coastal wetlands or into areas of special biological

importance, including marine reserves and kelp beds, shall not

significantly alter the overall ecological balance of the receiving

area.

   (d) Independent baseline studies of the existing marine system

should be conducted in the area that could be affected by a new or

expanded industrial facility using seawater in advance of the

carrying out of the development.

   (e) (1) Adequately treated recycled water should, where feasible,

be made available to supplement existing surface and underground

supplies and to assist in meeting future water requirements of the

coastal zone, and consideration, in statewide programs of financial

assistance for water pollution or water quality control, shall be

given to providing optimum water recycling and use of recycled water.

   (2) If recycled water is available for industrial use, any

discharge to waters in the coastal zone, including the San Francisco

Bay, after industrial use, may be authorized if all of the following

conditions are met:

   (A) The discharge will not unreasonably affect beneficial uses.

   (B) The discharge is consistent with applicable water quality

control plans and state policy for water quality control.

   (C) The use of recycled water is consistent with Chapter 7

(commencing with Section 13500).

   (D) The discharge is consistent with all applicable requirements

of Chapter 5.5 (commencing with Section 13370).

   (E) The discharge is to the same general receiving water location

as that to which the wastewater would be discharged if not reused.

   (3) Any requirement imposed pursuant to Section 13263 or 13377

shall be adjusted to reflect a credit for waste present in the

recycled water before reuse.  The credit shall be limited to the

difference between the amount of waste present in the nonrecycled

water supply otherwise available to the industry and the amount of

waste present in the recycled water.

   (4) If the amount of waste in the discharge exceeds prescribed

requirements because the amount of waste in the recycled water is in

excess of that agreed to be furnished by the supplier to the

discharger, no enforcement action shall be taken against the

discharger unless both of the following statements apply:

   (A) The supplier of the recycled water fails to correct the

problem within 30 days after the cause of the problem is identified,

or within any greater period of time agreed to by the appropriate

regional board.

   (B) The discharger continues to receive the recycled water from

the supplier.

   (f) This section shall not apply to industrial discharges into

publicly owned treatment works.