[Federal Register Volume 85, Number 198 (Tuesday, October 13, 2020)]
[Rules and Regulations]
[Pages 64377-64383]
[FR Doc No: 2020-22608]

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DEPARTMENT OF COMMERCE

Bureau of Industry and Security

15 CFR Part 705

[Docket No.<PHONE_NUMBER>]
RIN 0694-AI26

Procedures To Grant Relief From the Quantitative Limitation
Applicable to Certain Steel Articles for Brazil for Parties With
Preexisting Contracts That Meet Specified Criteria

AGENCY: Bureau of Industry and Security, U.S. Department of Commerce.

ACTION: Temporary final rule.

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SUMMARY: This temporary final rule establishes procedures to grant
relief from the quantitative limitation applicable to certain steel
articles for Brazil for parties with preexisting contracts that meet
specified criteria as authorized by the President as part of the action
he took to adjust imports under Section 232 of the Trade Expansion Act
of 1962, as amended (``section 232'').

DATES: Effective date: This temporary final rule is effective October
13, 2020, through December 31, 2020.

    See SUPPLEMENTARY INFORMATION section for information on submitting
certifications for relief from the quantitative limitation for Brazil
for steel articles.

ADDRESSES: All certifications for relief from the quantitative
limitation for Brazil for steel articles on this temporary final rule
must be submitted through the email<EMAIL_ADDRESS>
FOR FURTHER INFORMATION CONTACT: For questions regarding this temporary
final rule, contact Erika Maynard at<PHONE_NUMBER> or via email
<EMAIL_ADDRESS>or to fd8e89989891cfcecfd098858dbd9f948ed399929ed39a928b.

SUPPLEMENTARY INFORMATION:

Background

    On August 28, 2020, President Trump issued Proclamation 10064 (85
FR 54877), Adjusting Imports of Steel Into the United States, which
lowered one of the section 232 quantitative limitations applicable to
Brazil for the remainder of 2020 and added a new basis for relief from
those lowered quantitative limitations. The President determined that
the modification to the quantitative limitations applicable to certain
steel products was necessary to preserve the effectiveness of the
alternative means to address the threatened impairment of national
security posed by steel article imports which were previously agreed to
with Brazil. This temporary final rule implements the President's
directive to the Secretary of Commerce (Secretary) to grant relief from
the modified quantitative limitations in a limited aggregate amount
under specific circumstances related to the fulfillment of existing
contracts.

Background on Quantitative Limitations Applicable to Brazil

    On January 11, 2018, the Secretary transmitted to President Trump a
report on his investigation into the effect of imports of steel mill
articles (steel articles) on the national security of the United States
under section 232 of the Trade Expansion Act of 1962, as amended (19
U.S.C. 1862). The Secretary found and advised President Trump that
steel articles were being imported into the United States in such
quantities and under such circumstances as to threaten to impair the
national security of the United States.
    In Proclamation 9705 of March 8, 2018 (Adjusting Imports of Steel
Into the United States) (83 FR 11625), President Trump concurred in the
Secretary's finding that certain steel articles were being imported
into the United States in such quantities and under such circumstances
as to threaten to impair the national security of the United States,
and decided to adjust the imports of these steel articles by imposing a
25 percent ad valorem tariff on such articles imported from most
countries.
    In Proclamation 9705, President Trump further stated that any
country with which the United States has a security relationship is
welcome to discuss with the United States alternative ways to address
the threatened impairment of the national security caused by imports
from that country. The President noted that, should the United States
and any such country arrive at a satisfactory alternative means to
address the threat to the national security such that he determines
that imports from that country no longer threaten to impair the
national security, the President may remove or modify the restriction
on steel article imports from that country.

Alternative Means To Address the Threatened Impairment to U.S. National
Security Posed by Steel Articles Imported From Brazil

    In Proclamation 9759 of May 31, 2018 (Adjusting Imports of Steel
Into the United States) (85 FR 25857), President Trump noted that the
United States had agreed on measures with Brazil that would provide
effective, long-term alternative means to address Brazil's contribution
to the threatened impairment to our national security. These included
quantitative limitations that restrict the volume of steel articles
imported into the United States from Brazil. In light of these agreed-
upon measures, President Trump determined that steel article imports
from Brazil would no longer threaten to impair the national security
and decided to exclude Brazil from the tariff proclaimed in
Proclamation 9705, as amended.

Monitoring Implementation of Quantitative Limitations

    In Proclamation 9759, President Trump also noted that the United
States would monitor the implementation and effectiveness of the
quantitative limitations applicable to steel article imports from
Brazil, and directed the Secretary to inform him of any circumstance
that in the Secretary's opinion might indicate that an adjustment of
the quantitative limitation is necessary.
    The Secretary has advised President Trump that there have been
significant changes in the United States steel market since the
President decided to exclude Brazil, on a long-term basis, from the
tariff proclaimed in Proclamation 9705, as amended. The United States
steel market has contracted in 2020. After increasing in 2018 and 2019,
steel shipments by domestic producers through June of this year were
approximately 15 percent lower than shipments for the same time period
in 2019, with shipments in April and May of this year more than 30
percent lower than the shipments in the same months in 2019. The
Secretary has further advised President Trump that domestic producers'
adjusted year-to-date capacity utilization rate through August 15, 2020
is below 70 percent and that the rate has been near or below 60 percent
since the second week of April. Brazil is the second largest source of
steel imports to the United States and the largest source of imports of
semi-finished steel products. Moreover, while imports from most
countries have declined this year in a manner commensurate with this
contraction, imports from Brazil have decreased only slightly.

Actions Taken To Address Significant Changes in the United States Steel
Market

    In light of these significantly changed market conditions,
President Trump determined in Proclamation 10064 that absent
modifications, the alternative measures applicable to Brazilian steel
imports would be ineffective in eliminating the threat to the national
security posed by imports of such articles in the current environment.
The United States and Brazil have held consultations regarding Brazil's
steel exports to the United States in light of the changed market
conditions. As a result of these discussions, the United States will
lower, for the remainder of 2020, one of the quantitative limitations
set forth in Proclamation 9759 applicable to steel articles imported
from Brazil.
    In President Trump's judgment, this modification will preserve the
effectiveness of the alternative means to address the threatened
impairment to U.S. national security by further restraining steel
article exports to the United States from Brazil during the current
period of market contraction. In light of these modifications,
President Trump has determined that steel article imports from Brazil
will not threaten to impair the national security and thus has decided
to continue to exclude Brazil from the tariff proclaimed in
Proclamation 9705, as amended. The United States and Brazil will hold
further consultations in December 2020 to discuss the state of the
steel trade

between the two countries in light of then-prevailing market
conditions.

Ensuring That Lowered Quantitative Limitations for Brazil Do Not Delay
or Disrupt Specific Production Activities in the United States Already
Contracted for Delivery

    President Trump in Proclamation 10064 noted that he has been
informed that a reduction in the quantitative limitation set forth in
Proclamation 9759 applicable to certain steel article imports from
Brazil may delay or disrupt specific production activities in the
United States for which imports of the steel articles covered by the
quantitative limitations have already been contracted for delivery in
the fourth quarter of this year. In light of these circumstances, and
after considering the impact on the economy and the national security
objectives of section 232, President Trump in Proclamation 10064
determined to direct the Secretary to provide relief from the modified
quantitative limitations in certain limited circumstances specified in
more detail below and in paragraph (j) of this rule. This relief is in
addition to the relief from the quantitative limitations that the
Secretary is already authorized to provide pursuant to clause 1 of
Proclamation 9777 of August 29, 2018 (Adjusting Imports of Steel Into
the United States) (83 FR 45025). However, exclusion requests submitted
under paragraph (j) involve different criteria and procedures than
those submitted under existing paragraph (c) and determined pursuant to
the criteria and procedures described in existing paragraphs (a)-(i).
In addition, the Secretary may not, prior to January 1, 2021, grant
relief under paragraph (c) for steel articles for which relief is
granted under paragraph (j).
    Proclamation 10064 sets forth several directives that are being
implemented in this rule. Clause 1 of Proclamation 10064 specifies that
the quantitative limitation applicable to imports of steel articles
classified under subheading 9903.80.57 of subchapter III of chapter 99
of the HTSUS from Brazil are being lowered for the remainder of
calendar year 2020, and specifies that the new quantitative limitation
is described in the Annex to the proclamation. For calendar year 2021
and for subsequent years, the annual aggregate limit for steel articles
classified under this subheading from Brazil reverts to the annual
aggregate limit for Brazil set forth in the Annex to Proclamation 9759,
unless that limit is further modified or terminated by President Trump.
    Under clause 2 of Proclamation 10064, President Trump directed that
the Secretary shall, on an expedited basis, grant relief from the
modified quantitative limitation now applicable to subheading
9903.80.57 of subchapter III of chapter 99 of the HTSUS for Brazil for
any steel article where:
    (i) The party requesting relief entered into a contract or other
written agreement for the production and shipment of such steel article
before August 28, 2020;
    (ii) such agreement specifies the quantity of such steel article
that is to be produced and shipped to the United States prior to
December 31, 2020;
    (iii) such steel article is to be used in production activities in
the United States and such steel article cannot be procured from
another supplier to meet the delivery schedule and specifications
contained in such agreement; and
    (iv) lack of relief from the quantitative limitation on such steel
article would significantly disrupt the production activity in the
United States for which the steel article specified in such agreement
is intended.
    Also under clauses 2 and 5, President Trump specified that the
volume of imports for which the Secretary grants relief under this
clause shall not exceed 60,000,000 kilograms in the aggregate, and
under clauses 1 and 5 that any steel article for which relief is
granted must be entered for consumption or withdrawn from warehouse for
consumption on or before December 31, 2020. Also under clause 5,
President Trump further provided that the Secretary may not, prior to
January 1, 2021, grant further relief for such an article through the
preexisting exclusion request process (set out in paragraphs (a)-(i) of
this supplement) applicable to items not available in the United States
in sufficient or reasonably available quantity or of satisfactory
quality or based on specific national security considerations, as
provided for by clause 1 of Proclamation 9777.
    Under clause 3 of Proclamation 10064, President Trump directed that
the Secretary shall grant relief under clause 2 of this proclamation
only upon receipt of a sworn statement signed by the chief executive
officer and the chief legal officer of the party requesting relief,
attesting that:
    (i) The steel article for which relief is sought and the associated
contract or other written agreement meet the criteria for relief set
forth in clause 2(i) through (iv) of Proclamation 10064;
    (ii) the party requesting relief will accurately report to U.S.
Customs and Border Protection (CBP), in the manner that CBP prescribes,
the quantity of steel articles entered for consumption, or withdrawn
from warehouse for consumption, pursuant to any grant of relief; and
    (iii) the quantity of steel articles entered pursuant to a grant of
relief will not exceed the quantity for which the Secretary has granted
relief.
    Clause 3 of Proclamation 10064 also specified that the Secretary
shall notify CBP of any grant of relief made pursuant to Proclamation
10064. Clause 3 further provided that the Secretary shall revoke any
grant of relief under clause 2 of the proclamation if the Secretary
determines at any time after such grant that the criteria for relief
have not been met and may, if the Secretary deems it appropriate,
notify the Attorney General of the facts that led to such revocation.
    Under clause 4 of Proclamation 10064, President Trump directed that
as soon as practicable, the Secretary shall issue procedures for the
requests for relief described in clauses 2 and 3 of the proclamation,
which BIS is doing on behalf of the Secretary with the publication of
this temporary final rule. Lastly, clause 4 specified that CBP shall
implement relief provided under clause 2 of this proclamation as soon
as practicable.
    Under clause 5 of Proclamation 10064, until the modified
quantitative limitation provided under subheading 9903.80.57 of
subchapter III of chapter 99 of the HTSUS from Brazil has been reached,
CBP will count steel articles granted relief under clause 2 of
Proclamation 10064 toward that modified quantitative limitation when
the steel article is entered for consumption or withdrawn from
warehouse for consumption. (Clause 5 also provides that steel articles
for which relief is granted pursuant to clause 2 of Proclamation 10064
shall be subject to the duty treatment provided in subheading
9903.80.62 of subchapter III of chapter 99 of the HTSUS for Brazil, as
established by the Annex to Proclamation 10064).

Changes Made in This Temporary Final Rule

    In Supplement No. 1 to Part 705--Requirements for Submissions
Requesting Exclusions from the Remedies Instituted in Presidential
Proclamation 9705 of March 8, 2018 Adjusting Imports of Steel Articles
into the United States, under new paragraph (j) (Certification for
requesting relief from quantitative limitation for Brazil), this
temporary final rule makes the following changes:
    In Note to paragraph (c)(2), this temporary final rule adds one
sentence to the end of this note to provide a cross

reference to new paragraph (j) which is added by this rule. The Note to
paragraph (c)(2) provides guidance to directly affected individuals or
organizations located in the United States seeking exclusions from
quantitative limitations imposed on certain countries. The new sentence
that this rule adds to the note specifies that directly affected
individuals or organizations located in the United States and importing
steel articles from Brazil, a country subject to quantitative
limitations, should first review new paragraph (j) prior to submitting
any exclusion requests.
    This temporary final rule adds new paragraph (j) to describe the
requirements to request relief from the quantitative limitations
applicable to steel article imports from Brazil under the new process
created by clause 2 of Proclamation 10064. The introductory text of
paragraph (j) provides background on the quantitative limitations for
steel articles for Brazil. This introductory text references
Proclamation 9759 on May 31, 2018 and the most recent Proclamation
10064 of August 28, 2020. The introductory text explains that paragraph
(j) provides a process for relief separate from the section 232
exclusions process as required by Proclamation 10064. Under this
process a party may request relief from the quantitative limitation for
certain steel articles from Brazil, which will be approved by the
Department of Commerce (the ``Department'') under stated criteria.
    Paragraph (j) describes the requirements for a party to obtain this
relief, how the Department reviews these requests for relief, the
administration and use of granted requests of relief, and when
revocation of grants of relief may occur. These procedures are all
contained in paragraph (j), which unless extended on or before December
31, 2020, will be removed from the regulations on January 1, 2021. This
process of requesting grants for relief from the quantitative
limitations for Brazil is a separate process from the 232 exclusions
process described elsewhere in supplement no. 1 to part 705.
    New paragraph (j) consists of five paragraphs: (j)(1) (Sworn
statement required to grant relief); (j)(2) (Where to submit requests
for grants of relief?); (j)(3) (Disposition of requests for grants of
relief); (j)(4) (Administration and use of granted requests of relief);
and (j)(5) (Revocation of grants of relief).
    New paragraph (j)(1) specifies that pursuant to clause 3 of
Proclamation 10064, the Secretary will grant relief from the lowered
quantitative limitation for steel articles under subheading 9903.80.57
of subchapter III of chapter 99 of the HTSUS for Brazil only upon
receipt of a sworn statement signed by the chief executive officer and
the chief legal officer of the party requesting relief. The sworn
statement made under new paragraph (j)(1) must attest to the criteria
specified in paragraphs (j)(1)(i) to (iii). These criteria are required
in order to determine whether the steel article for which relief is
sought and the associated contract or other written agreement meet the
criteria for relief set forth in clause 2(i) through (iv) of
Proclamation 10064.
    The party requesting relief must certify under paragraph
(j)(1)(i)(A) that they entered into a contract or other written
agreement for the production and shipment of such steel article before
August 28, 2020. The party requesting relief must also include in the
certification a description of the steel article by HTS classification
and Chapter 99 quota category HTS classification. The certification
must also specify under paragraph (j)(1)(i)(B) that the associated
contract or other written agreement states the quantity of such steel
article that is to be produced and shipped to the United States prior
to December 31, 2020. The party requesting relief must certify under
paragraph (j)(1)(i)(C) that such steel article is to be used in
production activities in the United States. This includes certifying
that such steel article cannot be procured from another supplier to
meet the delivery schedule and specifications contained in such
agreement. Lastly, under the certification requirement under paragraph
(j)(1)(i)(D), the party requesting relief must certify that lack of
relief from the quantitative limitation on such steel article would
significantly disrupt the production activity in the United States for
which the steel article specified in such agreement is intended.
    Requesters are required to comply with the certification
requirement under paragraph (j)(1)(ii) in order to ensure that if
approved, the relief provided can be properly administered and enforced
by CBP. Specifically, the party requesting relief must accurately
report to CBP, in the manner that CBP prescribes, the quantity of steel
articles entered for consumption, or withdrawn from warehouse for
consumption, pursuant to any grant of relief. The last requirement of
the certification under paragraph (j)(1)(iii) is to acknowledge that
the requester will not, in entering steel articles pursuant to any
grant of relief, exceed the quantity for which the Secretary grants
relief.
    Under new paragraph (j)(2), this temporary final rule specifies
where to submit requests for grants of relief. This paragraph specifies
that all requests for grants of relief pursuant to paragraph (j) must
be in electronic form and submitted by email to<EMAIL_ADDRESS>This paragraph specifies that in order to submit a
request for a grant of relief under paragraph (j), the request must be
submitted as an attachment to the email sent to<EMAIL_ADDRESS>Paragraph (j)(2) specifies the only information
required to be submitted for these requests is the sworn statement
under paragraph (j)(1).
    New paragraph (j)(3) describes how the Department will dispose of
requests for grants of relief. Paragraph (j)(3) specifies that the
Department will grant requests for relief that meet the criteria
specified in paragraphs (j)(1) and (2) until such time as the maximum
quantity under this relief program is met. Paragraph (j)(3) specifies
that pursuant to Proclamation 10064, the volume of imports for which
the Secretary grants relief under this paragraph shall not exceed
60,000,000 kilograms in the aggregate. The Department will use a
``first submitted, first approved'' process until such time as the
maximum aggregate limit has been approved and will not accept
submissions after this limit is reached.
    This rule also adds a Note to paragraph (j)(3) to provide guidance
on when the Department will deny a requested grant for relief. This
note specifies that denials will occur if the sworn statement does not
meet the requirements specified in paragraphs (j)(1) and (2). It also
specifies that requests for relief will be denied to the extent
granting the request would result in the aggregate amount of imports
for which relief is granted under paragraph (j) exceeding 60,000,000
kilograms. This note also clarifies that once the aggregate amount of
approved grants for relief reaches 60,000,000 kilograms, the Department
will post a statement on the BIS website under www.bis.doc.gov/232-steel-Brazil to alert requesters that the aggregate limit has been
reached, so that they are informed that they may no longer submit
requests for grants of relief. This statement will save time for
requesters, as well as the Department.
    This temporary final rule adds new paragraph (j)(4) to specify how
granted requests for relief will be administered and the validity
periods for these granted requests for relief. Any relief granted under
paragraph (j) will only be valid if the subject steel article is
entered for consumption, or withdrawn from warehouse for consumption,
on or before December 31, 2020. Paragraph

(j)(4) also specifies that further relief may not be granted for such
article by the Secretary under clause 1 of Proclamation 9777.
    This temporary final rule adds new paragraph (j)(5) to specify when
the Secretary may revoke grants of relief made pursuant to paragraph
(j). Paragraph (j)(5) specifies that the Secretary will revoke any such
grant of relief if the Secretary determines at any time after relief is
granted that the criteria for relief have not been met. Paragraph (j)
also specifies that if the Secretary deems it appropriate, he may
notify the Attorney General of the facts that led to such revocation.

Rulemaking Requirements

    1. Executive Orders 13563 and 12866 direct agencies to assess all
costs and benefits of available regulatory alternatives and, if
regulation is necessary, to select regulatory approaches that maximize
net benefits (including potential economic, environmental, public
health and safety effects, distributive impacts, and equity). Executive
Order 13563 emphasizes the importance of quantifying both costs and
benefits, of reducing costs, of harmonizing rules, and of promoting
flexibility. This rule has been determined to be a ``significant
regulatory action,'' although not economically significant, under
section 3(f) of Executive Order 12866. Pursuant to clause 4 of
Proclamation 10064 of August 28, 2020, this rule is exempt from
Executive Order 13771 (85 FR 54877, September 2, 2020).
    2. The Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq.)
(PRA) provides that an agency generally cannot conduct or sponsor a
collection of information, and no person is required to respond to nor
be subject to a penalty for failure to comply with a collection of
information, unless that collection has obtained Office of Management
and Budget (OMB) approval and displays a currently valid OMB Control
Number.
    This temporary final regulation involves one collection currently
approved by OMB with the following control number: Procedures for
Submitting Requests for Expedited Relief from Quantitative Limits--
Existing Contract: Section 232 National Security Investigations of
Steel Imports (OMB control number 0694-0140).
    BIS is making a change to this collection for OMB control number
0694-0140 to account for the certification in the form of a sworn
statement that needs to be made and submitted to the Department by
requesters via email to<EMAIL_ADDRESS>under Supplement No. 1
to 15 CFR part 705, paragraphs (j)(1) and (2), when requesting relief
from the quantitative limitation applicable to Brazil for certain steel
articles. Any comments regarding the collection of information
associated with this rule, including suggestions for reducing the
burden, may be sent to Jasmeet K. Seehra, Office of Management and
Budget (OMB), by email to<EMAIL_ADDRESS>or online at
https://www.reginfo.gov/public/do/PRAMain.
    3. This rule does not contain policies with Federalism implications
as that term is defined in Executive Order 13132.
    4. The provisions of the Administrative Procedure Act (5 U.S.C.
553) requiring notice of proposed rulemaking, the opportunity for
public comment, and a delay in effective date are inapplicable because
this regulation involves a military or foreign affairs function of the
United States. (See 5 U.S.C. 553(a)(1)). The reduction in the
quantitative limitation for certain steel articles from Brazil is
needed to protect U.S. national security interests in light of recent
deterioration in the U.S. steel industry that was being further harmed
by steel imports from Brazil, as described further below. This needed
measure to protect U.S. national security could also result in adverse
impacts on certain parties in the United States that import steel
articles from Brazil, so this rule creates a process to allow those
parties to request relief that meet specified criteria. Creating this
process to allow parties to request relief is needed to ensure that the
required actions needed to protect U.S. national security can be taken
without doing unintended harm to other parts of the U.S. economy and
national security.
    As explained in the report submitted by the Secretary to the
President on January 11, 2018, steel is being imported into the United
States in such quantities or under such circumstances as to threaten to
impair the national security of the United States and therefore the
President has implemented these remedial adjustments of imports (as
described in in Proclamation 9705 of March 8, 2018, as amended) to
protect U.S. national security interests.
    In Proclamation 9759, President Trump directed the Secretary to
monitor implementation of quantitative limitations applicable to steel
article imports from Brazil and inform him of any circumstance that in
the Secretary's opinion might indicate that an adjustment of the
quantitative limitation is necessary. The Secretary has advised
President Trump that there have been significant changes in the United
States steel market since the time President Trump decided to exclude,
on a long-term basis, Brazil from the tariff proclaimed in Proclamation
9705.
    The United States steel market has contracted in 2020. After
increasing in 2018 and 2019, steel shipments by domestic producers
through June of this year are approximately 15 percent lower than
shipments for the same time period in 2019, with shipments in April and
May of this year more than 30 percent lower than the shipments in the
same months in 2019. The Secretary has further advised President Trump
that domestic producers' adjusted year-to-date capacity utilization
rate through August 15, 2020 is below 70 percent and that the current
rate has been near or below 60 percent since the second week of April.
Brazil is also the second largest source of steel imports to the United
States and the largest source of imports of semi-finished steel
products. Moreover, imports from most countries have declined this year
in a manner commensurate with this contraction, whereas imports from
Brazil have decreased only slightly.
    In light of these significantly changed market conditions,
President Trump determined in Proclamation 10064 that the alternative
measures regarding Brazilian steel imports, without any modifications,
would be ineffective in eliminating the threat to the national security
posed by imports of such articles in the current environment. The
United States and Brazil have held consultations regarding Brazil's
steel exports to the United States. As a result of these discussions,
the United States will lower, for the remainder of 2020, one of the
quantitative limitations set forth in Proclamation 9759 applicable to
steel articles imported from Brazil. In President Trump's judgment,
this modification will preserve the effectiveness of the alternative
means to address the threatened impairment to U.S. national security by
further restraining steel article exports to the United States from
Brazil during this period of market contraction. In light of this
modification, President Trump has determined that steel article imports
from Brazil will not threaten to impair the national security and thus
has decided to continue to exclude Brazil from the tariff proclaimed in
Proclamation 9705, as amended.
    President Trump in Proclamation 10064 noted that he has been
informed that a reduction in this quantitative limitation set forth in
Proclamation 9759 applicable to steel article imports from Brazil may
delay or disrupt specific production activities in the

United States for which imports of steel articles covered by the
quantitative limitation have already been contracted for delivery in
the fourth quarter of this year. In light of these circumstances, and
after considering the impact on the economy and the national security
objectives of section 232, President Trump directed the Secretary in
Proclamation 10064 to provide relief from the modified quantitative
limitations in certain limited circumstances specified in paragraph (j)
of this rule.
    The implementation of the President's directive includes the
creation of a process by which domestic parties can submit a
certification requesting relief from this modified quantitative
limitation for Brazil. Establishing these procedures in this temporary
final rule are needed to ensure that the reduction in this quantitative
limitation for Brazil can occur as needed to protect U.S. national
security interests while not causing unintended economic harm for those
affected parties in the U.S. with existing contracts that meet the
specified criteria in this rule.
    In addition, the Department finds that there is good cause under 5
U.S.C. 553(b)(B) to waive the provisions of the Administrative
Procedure Act requiring prior notice and the opportunity for public
comment and under 5 U.S.C. 553(d)(1) and (d)(3) to waive the delay in
effective date because this rule is a substantive rule which grants or
recognizes an exemption and such delays would be either impracticable
or contrary to the public interest.
    Under clause 4 of Proclamation 10064, President Trump directed that
as soon as practicable, the Secretary shall issue procedures for the
requests for relief described in clauses 2 and 3 of this proclamation,
which BIS is doing on behalf of the Secretary with the publication of
this temporary final rule. Clause 4 also specified that CBP shall
implement relief provided under clause 2 of this proclamation as soon
as practicable, which is also contingent on the publication of this
temporary final rule. If this rule was delayed for public comment,
those impacted parties that are intended to benefit from this relief
would not be allowed to benefit from this exemption and may not be able
to import steel articles from Brazil when above the reduced
quantitative limitations.
    The provisions of new paragraph (j) are of a temporary nature. As
directed by President Trump, any steel article for which relief is
granted under clause 2 of Proclamation 10064 must be entered for
consumption, or withdrawn from warehouse for consumption, on or before
December 31, 2020. Because of the immediate need for these provisions
and the short term during which these provisions will be effective
(i.e., from October 13, 2020 through December 31, 2020), it would be
impractical to allow for public comments or a delay in effective date
because by the time the changes became effective the public would have
very little time to benefit from these changes.
    Because a notice of proposed rulemaking and an opportunity for
prior public comment are not required for this rule by 5 U.S.C. 553, or
by any other law, the analytical requirements of the Regulatory
Flexibility Act, 5 U.S.C. 601 et seq., are not applicable. Accordingly,
no regulatory flexibility analysis is required and none has been
prepared.

List of Subjects in 15 CFR Part 705

    Administrative practice and procedure, Business and industry,
Classified information, Confidential business information, Imports,
Investigations, National security.

    For the reasons set forth in the preamble, part 705 of subchapter A
of 15 CFR chapter VII is amended as follows:

PART 705--[AMENDED]

0
1. The authority citation for part 705 continues to read as follows:

    Authority: Section 232 of the Trade Expansion Act of 1962, as
amended (19 U.S.C. 1862) and Reorg. Plan No. 3 of 1979 (44 FR 69273,
December 3, 1979).

0
2. Supplement No. 1 to part 705 is amended:
0
a. By revising the heading;
0
b. By adding one sentence to the end of Note to Paragraph (c)(2); and
0
c. By adding paragraph (j).
    The additions and revision read as follows:

Supplement No. 1 to Part 705--Requirements for Submissions Requesting
Exclusions From the Remedies Instituted in Presidential Proclamations
Adjusting Imports of Steel Articles Into the United States

* * * * *
    (c) * * *
    (2) * * *

    Note to paragraph (c)(2): * * * Parties intending to request an
exclusion from quantitative limitations applicable to imports of
items classified under subheading 9903.80.57 of subchapter III of
chapter 99 of the HTSUS for Brazil should consult paragraph (j) of
this supplement prior to submitting an exclusion request.

* * * * *
    (j) Certification for requesting relief from quantitative
limitation for Brazil. Brazil is a country subject to quantitative
limitations for steel articles. Pursuant to Proclamation 10064 of
August 28, 2020, the United States will lower, for the remainder of
2020, one of the quantitative limitations set forth in Proclamation
9759 of May 31, 2018 (Adjusting Imports of Steel Into the United
States) applicable to certain steel articles imported from Brazil in
order to protect U.S. national security interests. President Trump in
Proclamation 10064 noted that he has been informed that a reduction in
this quantitative limitation set forth in Proclamation 9759 applicable
to steel article imports from Brazil may delay or disrupt specific
production activities in the United States for which imports of steel
articles covered by this quantitative limitation have already been
contracted for delivery in the fourth quarter of 2020. In light of
these circumstances, and after considering the impact on the economy
and the national security objectives of section 232 of the Trade
Expansion Act of 1962, as amended, President Trump in Proclamation
10064 directed the Secretary to provide relief from this modified
quantitative limitation in certain limited circumstances that are
specified in Proclamation 10064 and repeated in this paragraph (j).
This authority is in addition to the relief from the quantitative
limitations that the Secretary is already authorized to provide
pursuant to clause 1 of Proclamation 9777 of August 29, 2018 (Adjusting
Imports of Steel Into the United States), and involves different
exclusion criteria and procedures. This paragraph (j) describes what
must be done to obtain this relief, how the U.S. Department of Commerce
reviews these requests for relief, the administration and use of
granted requests of relief, and when revocation of grants of relief may
occur.
    (1) Sworn statement required to grant relief. The Secretary will
grant relief from the modified quantitative limitation applicable to
imports of steel articles classified under subheading 9903.80.57 of
subchapter III of chapter 99 of the HTSUS from Brazil only upon receipt
of a sworn statement signed by the chief executive officer and the
chief legal officer of the party requesting relief, attesting to the
following criteria:
    (i) The steel article for which relief is sought, (insert
description here of the steel article by HTS classification and Chapter
99 quota category HTS classification), and the associated contract or
other written agreement meet the criteria for relief set forth in
clause 2(i) through (iv) of Proclamation 10064, described here under
paragraphs

(j)(1)(i)(A) through (D) of this supplement:
    (A) The party requesting relief entered into a contract or other
written agreement for the production and shipment of such steel article
before August 28, 2020;
    (B) Such agreement specifies the quantity of such steel article
that is to be produced and shipped to the United States prior to
December 31, 2020;
    (C) Such steel article is to be used in production activities in
the United States and such steel article cannot be procured from
another supplier to meet the delivery schedule and specifications
contained in such agreement; and
    (D) Lack of relief from the quantitative limitation on such steel
article would significantly disrupt the production activity in the
United States for which the steel article specified in such agreement
is intended;
    (ii) The party requesting relief will accurately report to U.S.
Customs and Border Protection (CBP), in the manner that CBP prescribes,
the quantity of steel articles entered for consumption, or withdrawn
from warehouse for consumption, pursuant to any grant of relief; and
    (iii) The quantity of steel articles entered pursuant to a grant of
relief will not exceed the quantity for which the Secretary has granted
relief.
    (2) Where to submit requests for grants of relief? All exclusion
requests for grants of relief pursuant to this paragraph (j) must be in
electronic form and submitted to BIS by email<EMAIL_ADDRESS>In order to submit a request for a grant of relief,
you must submit your request for a grant of relief as an attachment to
the email sent to<EMAIL_ADDRESS>The only documentation
required for a request for a grant of relief is the sworn statement
required under paragraph (j)(1) of this supplement. There are no
objection, rebuttal, or surrebuttal submissions or review periods, and
no provisions of the exclusion request process specified in this
supplement apply except those provided in this paragraph (j).
    (3) Disposition of requests for grants of relief. The U.S.
Department of Commerce will grant requests for relief that meet the
criteria specified in paragraphs (j)(1) and (2) of this supplement
until such time as the maximum quantity under this relief program is
met, and will post granted requests publicly on the BIS website as
described below. In Proclamation 10064 under clause 2, President Trump
specified that the volume of imports for which the Secretary grants
relief under this clause shall not exceed 60,000,000 kilograms in the
aggregate and this paragraph (j)(3) imposes this same limitation. The
Department will use a ``first submitted, first approved'' process until
such time as the maximum aggregate limit has been approved and will not
accept submissions after this limit is reached. The Secretary will
notify CBP of any grant of relief made pursuant to this proclamation.

    Note to paragraph (j)(3): Denials will occur if the sworn
statement does not meet all of the requirements specified in
paragraphs (j)(1) and (2) of this supplement, or will be denied to
the extent the amount of imports for which the Secretary has granted
relief under this paragraph (j)(3) would exceed 60,000,000 kilograms
in the aggregate. Once the aggregate amount of approved grants for
relief reaches 60,000,000 kilograms, the U.S. Department of Commerce
will post a statement on the BIS website under www.bis.doc.gov/232-steel-Brazil to alert other requesters that the aggregate limit has
been reached, and no more requests will be approved.

    (4) Administration and use of granted requests of relief. Any
relief granted under paragraph (j)(3) of this supplement will only be
valid if the subject steel article is entered for consumption, or
withdrawn from warehouse for consumption, on or before December 31,
2020. Where a party has received relief under the provisions of this
paragraph (j), they are not eligible for further relief under clause 1
of Proclamation 9777 prior to January 1, 2021, for the same steel
article pursuant to an exclusion request submitted under paragraph (c)
of this supplement.
    (5) Revocation of grants of relief. The Secretary of Commerce will
revoke any grant of relief under paragraph (j)(3) of this supplement if
the Secretary determines at any time after such grant that the criteria
for relief to which the party must attest under paragraphs (j)(1)(i)
through (iii) of this supplement have not been met and may, if the
Secretary deems it appropriate, notify the Attorney General of the
facts that led to such revocation.

Matthew S. Borman,
Deputy Assistant Secretary for Export Administration.
[FR Doc. 2020-22608 Filed 10-8-20; 11:15 am]
BILLING CODE 3510-33-P


Comment Info: =================

General Comment:A dose-response study of OROS methylphenidate in children with attention-deficit/hyperactivity disorder.


[Federal Register Volume 88, Number 228 (Wednesday, November 29, 2023)]
[Notices]
[Pages 83406-83407]
[FR Doc No: 2023-26253]

=======================================================================
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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket Nos. FDA-2021-E-0792, FDA-2021-E-0793, and FDA-2021-E-0803]

Determination of Regulatory Review Period for Purposes of Patent
Extension; Olinvyk

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA or the Agency) has
determined the regulatory review period for Olinvyk and is publishing
this notice of that determination as required by law. FDA has made the
determination because of the submission of applications to the Director
of the U.S. Patent and Trademark Office (USPTO), Department of
Commerce, for the extension of a patent which claims that human drug
product.

DATES: Anyone with knowledge that any of the dates as published (see
SUPPLEMENTARY INFORMATION) are incorrect may submit either electronic
or written comments and ask for a redetermination January 29, 2024.
Furthermore, any interested person may petition FDA for a determination
regarding whether the applicant for extension acted with due diligence
during the regulatory review period by May 28, 2024. See ``Petitions''
in the SUPPLEMENTARY INFORMATION section for more information.

ADDRESSES: You may submit comments as follows. Please note that late,
untimely filed comments will not be considered. The https://www.regulations.gov electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of January 29, 2024. Comments
received by mail/hand delivery/courier (for written/paper submissions)
will be considered timely if they are received on or before that date.

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://www.regulations.gov
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note that if you include your
name, contact information, or other information that identifies you in
the body of your comments, that information will be posted on https://www.regulations.gov.
     If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand Delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket Nos.
FDA-2021-E-0792, FDA-2021-E-0793, and FDA-2021-E-0803 for
``Determination of Regulatory Review Period for Purposes of Patent
Extension; OLINVYK.'' Received comments, those filed in a timely manner
(see ADDRESSES), will be placed in the docket and, except for those
submitted as ``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m.
and 4 p.m., Monday through Friday,<PHONE_NUMBER>.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with Sec.  10.20 (21 CFR 10.20) and
other applicable disclosure law. For more information about FDA's
posting of comments to public dockets, see 80 FR 56469, September 18,
2015, or access the information at: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852,<PHONE_NUMBER>.

FOR FURTHER INFORMATION CONTACT: Beverly Friedman, Office of Regulatory
Policy, Food and Drug Administration, 10903 New Hampshire Ave., Bldg.
51, Rm. 6250, Silver Spring, MD 20993,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    The Drug Price Competition and Patent Term Restoration Act of 1984
(Pub. L. 98-417) and the Generic Animal Drug and Patent Term
Restoration Act (Pub. L. 100-670) generally provide that a patent may
be extended for a period of up to 5 years so long as the patented item
(human drug product, animal drug product, medical device, food
additive, or color additive) was subject to regulatory review by FDA
before the item was marketed. Under these acts, a product's regulatory
review period forms the basis for determining the amount of extension
an applicant may receive.
    A regulatory review period consists of two periods of time: a
testing phase and an approval phase. For human drug products, the
testing phase begins when the exemption to permit the clinical
investigations of the drug becomes effective and runs until the
approval phase begins. The approval phase starts with the initial
submission of an application to market the human drug product and
continues until FDA grants permission to market the drug product.
Although only a portion of a regulatory review period may count toward
the actual amount of extension that the Director of USPTO may award
(for example, half the testing phase must be subtracted as well as any
time that may have occurred before the patent was issued), FDA's
determination of the length of a regulatory review period for a human
drug product will include all of the testing phase and approval phase
as specified in 35 U.S.C. 156(g)(1)(B).
    FDA has approved for marketing the human drug product, Olinvyk
(oliceridine fumarate) indicated for the management of acute pain
severe enough to require an intravenous opioid analgesic and for whom
alternative treatments are inadequate. Subsequent to this approval, the
USPTO received patent term restoration applications for Olinvyk (U.S.
Patent Nos. 8,835,488; 9,309,234; 9,642,842) from Trevena, Inc., and
the USPTO requested FDA's assistance in determining the patents'
eligibility for patent term restoration. In a letter dated August 24,
2022, FDA advised the USPTO that this human drug product had undergone
a regulatory review period and that the approval of Olinvyk represented
the first permitted commercial marketing or use of the product.
Thereafter, the USPTO requested that FDA determine the product's
regulatory review period.

II. Determination of Regulatory Review Period

    FDA has determined that the applicable regulatory review period for
Olinvyk is 3,206 days. Of this time, 2,112 days occurred during the
testing phase of the regulatory review period, while 1,094 days
occurred during the approval phase. These periods of time were derived
from the following dates:
    1. The date an exemption under section 505(i) of the Federal Food,
Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 355(i)) became effective:
January 22, 2012. The applicant claims January 24, 2012, as the date
the investigational new drug application (IND) became effective.
However, FDA records indicate that the IND effective date was January
22, 2012, which was 30 days after FDA receipt of the IND.
    2. The date the application was initially submitted with respect to
the human drug product under section 505 of the FD&C Act: November 2,
2017. FDA has verified the applicant's claim that the new drug
application (NDA) for Olinvyk (NDA 210730) was initially submitted on
November 2, 2017.
    3. The date the application was approved or the effective date of
approval for a drug product recommended for control under the
Controlled Substances Act: October 30, 2020. FDA has verified the
applicant's claim that NDA 210730 was approved on August 7, 2020, and
the date of issuance of the interim final rule controlling the drug
under section 201(j) of the Controlled Substances Act was October 30,
2020.
    This determination of the regulatory review period establishes the
maximum potential length of a patent extension. However, the USPTO
applies several statutory limitations in its calculations of the actual
period for patent extension. In its applications for patent extension,
this applicant seeks 951 days of patent term extension.

III. Petitions

    Anyone with knowledge that any of the dates as published are
incorrect may submit either electronic or written comments and, under
21 CFR 60.24, ask for a redetermination (see DATES). Furthermore, as
specified in Sec.  60.30 (21 CFR 60.30), any interested person may
petition FDA for a determination regarding whether the applicant for
extension acted with due diligence during the regulatory review period.
To meet its burden, the petition must comply with all the requirements
of Sec.  60.30, including but not limited to: must be timely (see
DATES), must be filed in accordance with Sec.  10.20, must contain
sufficient facts to merit an FDA investigation, and must certify that a
true and complete copy of the petition has been served upon the patent
applicant. (See H. Rept. 857, part 1, 98th Cong., 2d sess., pp. 41-42,
1984.) Petitions should be in the format specified in 21 CFR 10.30.
    Submit petitions electronically to https://www.regulations.gov at
Docket No. FDA-2013-S-0610. Submit written petitions (two copies are
required) to the Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

    Dated: November 24, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-26253 Filed 11-28-23; 8:45 am]
BILLING CODE 4164-01-P


April 20, 2004 EPA Docket Center Environmental Protection Agency Office of Environmental Information Docket oei. docket@ epa. gov Mail Code 2822T 1200 Pennsylvania Ave NW Washington DC 20460 Office of Information and Regulatory Affairs Office of Management and Budget ( OMB) Attention: Desk Officer for EPA 725 17th Street NW Washington DC 20503 RE: Docket ID Number ORD 2003 0011 EPA ICR Number 2126.01 EPA Response to Comments from the Phthalate Esters Panel as presented in Document ID Number ORD 2003 0011 0021 The EPA has reviewed the comments of the Phthalate Esters Panel ( Panel), referenced in the document ID above, regarding EPA's Information Collection Request ( ICR) for the " Longitudinal Study of Young Children's Exposures in Their Homes to Selected Pesticides, Phthalates, Brominated Flame Retardants, and Perfluorinated Chemicals ( A Children's Environmental Exposure Research Study   CHEERS)." The Panel's comments focus on three points:

1) The Panel believes that the quantity, routes, and pathways of phthalate exposure are characterized by existing information such that the additional work of this study is not needed. 2) Existing information derived from CDC biomonitoring data demonstrates that phthalate exposures to the general population are well below levels that could be anticipated to pose health concerns, and therefore that no further regulation is needed. 3) The study design is inappropriate for phthalates.

The EPA has made a substantial effort to design a study that will provide both high quality and high quantity data that will have practical utility for improving our understanding of children's exposures to chemicals in their homes, for developing exposure assessment methodologies for non persistent chemicals, and for reducing the uncertainty of risk assessments for children. The study has been designed with the goal of collecting a large amount of data of practical utility to the Agency with lowest possible burden on the study participants. We do not believe that the comments submitted by the Panel adequately support their request that OMB should not approve the proposed collection unless phthalates are dropped from the study or unless the study design is changed. On the contrary, we believe that review of the data that they 2 cite and the issues they raise further support the need for additional research on phthalate exposures of very young children ( under three years of age), as proposed for this study.

The EPA disagrees with the Panel's assertion that the quantity, routes, and pathways of phthalate exposure are characterized by existing information and are sufficient. The Panel cites the work of Clark et al. to demonstrate the quantity of available data, the apportionment of routes, and estimates of exposure for different age groups. However, as discussed in detail below, the probabilistic analysis by Clark et al. was used to assess the exposure from environmental sources only; exposures from consumer product sources were not included in the estimates. Clark et al. also noted inadequacies in the food, indoor air, and house dust data used in the exposure estimates. The proposed study will address inadequacies in the model estimates by collecting measurement data in the participant's home. These data will be used by the EPA to make aggregate exposure estimates, which will be related to measurements of the phthalate metabolites in urine samples collected from the study participants.

The Panel believes that because existing information derived from CDC biomonitoring data demonstrates that phthalate exposures to the general population are well below levels that could be anticipated to pose health concerns, and therefore that no further regulation is needed. There are three points that should be raised with regard to this comment: ( 1) This study is not designed to collect data that will be used directly to regulate phthalates; this is not one of the objectives. ( 2) It should be recognized that there is a high level of uncertainty associated with the Brock et al. data that the Panel cites to support low levels of exposure for children under six years of age. For the 19 children in the Brock et al. study, the concentrations of monobutyl phthalate ranged from 4.1 to 2540 mg/ mL. For one child, the two urine samples were highly variable ( 14.4 and 2540 mg/ mL). Such a high level of uncertainty in the urine metabolite measurements reduces the confidence in comparisons to EPA reference doses. Collection of additional data is warranted. ( 3) Currently risk assessments are performed for individual chemicals. However, in the past several years, cumulative risk assessment, aggregate exposure assessment, and research on chemical mixtures has taken on increased importance. Assessing cumulative risk through complex exposures is one of the Agency's high priorities. One of the primary objectives of this study is to evaluate methodologies for estimating aggregate exposures for very young children. The design of this study will address a number of Agency needs. It is imperative that the EPA move forward in developing methodologies that will improve the risk assessment process and reduce uncertainty of risk assessments for young children.

The Panel's third point, that the study design is not appropriate for phthalates is incorrect. The study design was developed to study current use pesticides that are registered for indoor use. These are primarily the pyrethrins and synthetic pyrethroids, which are non persistent chemicals. In its decision to include phthalates in this study, the EPA considered the fact that the phthalates were also non persistent chemicals. The collection protocols for pesticides are applicable to the phthalates. The pyrethroid pesticides and the phthalates are metabolized and eliminated from the body at similar rates. Therefore the urine collection protocol will be appropriate for both classes 3 of chemicals. Other issues raised by the Panel regarding the study design are not considered to be valid within the context of the objectives for this study. Those issues are discussed below.

The following is a more detailed discussion of the specific points raised by the Panel.

Panel Comment: EPA states that the reasons for this study " are to better identify the exposure factors, routes, and pathways of exposure for these chemicals, thus improving the Agency's ability to regulate these chemicals, conduct meaningful risk assessments, and develop future studies ." 69 Fed. Reg. at 10034 35 ( emphasis added). In its previous comments ( pp. 3 7), the Panel discussed the large quantity of data already available for phthalates   an amount paralleled by few other chemicals   and the many risk assessments already performed on these chemicals. The conclusion from those data and risk assessments is that phthalate exposures pose very low health concerns and therefore that no further regulation is needed. EPA Response: The purpose of this study is not to conduct a regulatory risk assessment for phthalates or to develop data specifically for new regulation as implied by the Panel. The Office of Research and Development's ( ORD) mission is to provide the science behind EPA's decisions to protect health and the natural environment. This study is consistent with ORD's mission in that it will improve the tools and data for conducting exposure assessments for very young children. As stated in the Abstract of the Supporting Statement, " The study will help the Agency reduce uncertainty in exposure and risk assessments for children by providing data on exposure factors and validated tools for estimating children's exposure to contaminants, as well as providing much needed measurement data for model refinement." Therefore, although the Panel states "  that no further regulation is needed " ( for phthalates), additional research by the EPA that will generate data that will reduce uncertainty in exposure assessments is warranted. As stated in Section 2( b) of the Supporting Statement, one of the primary objectives of this study is to " validate the systematic approach for evaluating aggregate exposure described in the Draft Protocol." However, the Agency is now being asked to go beyond evaluating risks from aggregate exposures ( i. e., exposure to a single chemical by all routes and pathways) to evaluating cumulative risks from exposures to multiple pollutants and stressors over time. In addressing cumulative risks, we must move beyond quantifying exposures and risk to one chemical at a time at a relatively high level to understanding exposures to the mixtures of chemicals that are occurring at low levels in our environment. Because phthalates are commonly environmental contaminants, we feel that it is important to develop the tools and data for including phthalates in cumulative risks assessments. In addition, EPA uses epidemiological studies as well as risk assessments to evaluate health risks posed by environmental contaminants. The study will provide information on the most important factors associated with exposures to phthalates. These results can then be used to develop simple methods and questionnaires for assessing exposures in future epidemiological studies The EPA does not dispute that there is a large quantity of data available for phthalates. However, it is an error to imply that the quantity of data for a chemical is directly correlated to our understanding of exposures to the chemical. As discussed below, the systematic approach that will be used in this study will provide important data on routes and pathways of exposure for both residential use pesticides and phthalates. 4 Panel Comment: EPA states that existing data are insufficient " to show how young children's exposure to phthalates changes as a result of the age and developmental stages" or to characterize " metabolite levels for children younger than 6 years of age" ( Supporting Statement, p. 7). However, as discussed in the Panel's previous comments, existing data are sufficient to show that phthalate exposures vary little with age and would in all cases be well below health concern levels. For example, the CDC data provide the following exposures to dibutyl phthalate ( DBP), in micrograms per kilogram per day ( ug/ kg/ day):

DBP Exposure Levels, ug/ kg/ day Age Group Mean 95th percentile 6 11 0.90 3.71 12 19 0.52 2.05 20+ 0.80 3.86 In other words, mean exposure in each age group was less than 1 ug/ kg/ day, and the 95th percentile in each group was less than 4 ug/ kg/ day. In contrast, the EPA reference dose for DBP is 100 ug/ kg/ day   far above the exposures for any age group. 4 The no observed adverse effect level ( NOAEL) for DBP used by the National Toxicological Program Center for Evaluation for Risks to Human Reproduction is 50 milligrams per kilogram per day ( mg/ kg/ day), or 50,000 ug/ kg/ day   five orders of magnitude above the exposures of any age group. There are some variations among the values for each age group, but those variations are dwarfed by the magnitude of levels which would pose any health concern. As EPA points out, the CDC data do not cover children below 6 years of age. However, a study by Brock et al. ( 2002) does provide a median value of 2.6 ug/ kg/ day in 19 infants of approximately one year old. This value is higher than the values from the CDC data, which is not surprising since infants eat, drink and breathe more in comparison to their body weight than older children. However, in comparison to the EPA reference dose and the NTP CERHR NOAEL, the value is near the CDC values. Detailing the precise variations in closely grouped levels is unnecessary when all those levels are far before levels of concern. There is no reason to believe that children at any age or developmental stage would have exposures significantly different from those observed in the CDC and Brock studies. Even if one assumes that the Brock infants were for some reason all at the low end of the exposure spectrum, and that " real" exposures for children less than 6 years old are 10 times higher than seen in the Brock study ( 26 ug/ kg/ day), such values yet would be well below the EPA reference dose of 100 ug/ kg/ day and far below the NOAEL of 50,000 ug/ kg/ day. EPA Response: The EPA disagrees with the Panels assertion that there are sufficient data " to show how young children's exposure to phthalates changes as a result of the age and developmental stages" or to characterize " metabolite levels for children younger than 6 years of age." The data presented in the table are for children over age 6. It is not scientifically sound to extrapolate data from children older than 6 years to younger children for whom the factors impacting exposure may be substantially different. The EPA Risk Assessment Forum ( RAF), in its report, Guidance on Selecting the Appropriate Age Groups for Assessing Childhood Exposures to Environmental Contaminants, discusses the substantial developmental changes that 5 occur over the period from birth to 21 years of age and the potential impact on children's exposures. The EPA has followed the RAF guidance by designing the study so that measurements are made at times consistent with the RAF age bins of 1 3 months, 3 6 months, 6 12 months, 1 2 years, and 2 3 years, the periods of substantial changes in development and activities that may impact exposure. Exposures of children in this age group to chemicals in their homes are not well characterized. The EPA is not aware of longitudinal studies that have taken a systematic approach to performing aggregate exposure estimates for children in this age group to a suite of phthalates or that collected data that could be used to assess temporal variability in exposures. Although the Panel states that " There is no reason to believe that children at any age or developmental stage would have exposures significantly different from those observed in the CDC and Brock studies," the Panel fails to provide data to support that assumption. This study would provide the needed data. The Panel suggests that, although CDC does not collect data for children under 6 years of age, the median value of 2.6 µ g/ kg/ day in 19 infants of approximately one year old in the Brock et al. study should be sufficient to demonstrate that the levels of exposure are far below levels of concern. We do not believe that the Brock et al. study data are sufficient because of the limited number of samples collected and the very high variability in the urine measurements. The samples collected in the Brock et al. study consisted of two urine samples from 12 children and a single urine sample from seven children. The mean urinary metabolite level for monbutylphthalate ( MBP) was 117.4 ng/ mL. But the standard deviation of the measurement for the 31 samples was 287.6 ng/ mL, more than twice the mean, reflecting high variability in the MBP concentrations among the children. The range of MBP urine concentrations was from 4.1 to 2540 ng/ mL in the 31 samples. Of greater concern was the variability in the urine concentrations for the same children with two urine samples. Although there were cases where the urine MBP concentrations were reasonably similar, child 7 had measurements of 14.4 and 2540 ng/ mL, child 15 had measurements of 68.8 and 234 ng/ mL, and child 19 had measurements of 34.7 and 154 ng/ mL. Brock et al. concluded that " The large variation between samples from the same child at different times suggests that two spot urine samples alone probably do not adequately describe phthalate exposure for any individual child. Multiple urine samples from each individual child may be required to fully assess the exposure to phthalates." The EPA believes that the Panel has failed to adequately evaluate the available data and has drawn conclusions that are not supported by the data in the Brock et al. study. Contrary to the opinion of the Panel, the results of the Brock et al. study show that it is essential that we collect more data in order to be able to understand children's exposures to phthalates, the exposure levels, and the factors that effect those exposures. The design of EPA's proposed study will address the problem that Brock et al. has identified by collecting multiple urine samples ( six during each data collection event) at multiple times during the two year longitudinal study. Furthermore, because of the very high variability in the urinary concentrations in the Brock study, we do not believe any statement can be made about the levels of young children's exposure to phthalates. Because of this uncertainty, we should not attempt to relate exposure levels to EPA reference levels until more data are available.

Panel Comment: While it may be of academic interest to detail the slight variations in phthalate exposures among children, it is not of practical interest   with all exposures well below health 6 effect levels of concern, there is no need for agency intervention. Therefore, inclusion of phthalates in the proposed study would have no practical utility. EPA Response: As discussed above, the Brock et al. data show large variations in phthalate exposures, not " slight" variations. This study is not being performed out of academic interest to detail slight variations in phthalate exposures among children. Nor is this study being performed in response to a " need for Agency intervention." The study is intended to collect data that will serve as the scientific basis for EPA's exposure and risk assessment methodologies. There is a need to improve the risk assessment methodologies and to reduce uncertainty in risk assessments. This study will provide data for a suite of phthalates accumulated over sources, over time, and in concert with many other chemical contaminants. Results of the study are expected to have broad application to the risk assessment methodologies for non persistent chemicals. This study will provide data that will address the Agency's needs for improved methods for assessing both aggregate and cumulative exposures and risks. These data will be available to the Panel so that they can also improve their risk assessments.

Panel Comment: The Study Design Does Not Acknowledge the Non Persistence of Phthalates. The proposed study was designed and peer reviewed with respect to persistent chemicals. Phthalates are not persistent. EPA has acknowledged this by changing the title of the study, but it has not otherwise addressed the important ramifications of this distinction for the appropriateness of the study design with respect to phthalates. Phthalates are quickly metabolized and eliminated from the body, so that accurate measurement of phthalate exposures during a longitudinal study would require many urinary samples. Chapin et al. ( 2004) discuss the issue as follows: Phthalates . . . are cleared from the body with relative speed ( several days to a few weeks) and do not bioaccumulate significantly ( Tanaka et al. 1978). From the public health and environmental perspectives, this is incontrovertibly good, although it means that actually determining which levels of which compounds are adverse requires repeated biological sampling and analysis. More recent data indicates that metabolism is even faster. Anderson et al. ( 2001) found in human volunteer studies that urinary recovery of ingested phthalates was complete in 24 hours. A well designed longitudinal exposure study of phthalates would take human metabolism into account and plan for numerous samples. EPA's study design, however, involves only 5 or 6 visits over a 2 year period. Phthalate values for each visit will represent phthalate exposure over the day or two immediately preceding the sample visit, which may or may not be representative of phthalate exposures over the course of the two years. 6 It therefore is questionable whether the exposure factors from the study design will be applicable to phthalates   especially given the questions discussed below concerning potential bias in the sampling and lack of validated questionnaires. EPA Response: The Panel either has not adequately reviewed the study design or does not understand the study design. The study was designed and peer reviewed to address study objectives related to current use pesticides, which are non persistent chemicals. The pesticides that will be measured in the study include chlorpyrifos and diazinon, which although discontinued for indoor use may still be on homeowners shelves and available for use, and the current use pesticides including the pyrethrins and the synthetic pyrethroids. These pesticides are non persistent. The EPA recognizes that phthalates are non persistent. The original title of the study included the term " and Persistent Pollutants" because we proposed to measure 7 brominated flame retardants in the study ( See Study Design, Section 2.1, Objectives). The title was changed to state exactly what chemicals were being measured in the study. The study design is appropriate to address objectives related to phthalate exposures because it was originally developed to address objectives related to exposures to non persistent pesticides. The decision by the EPA to add phthalates recognized that both classes of chemicals were nonpersistent The Panel's criticism of the EPA study design with respect to the timing of the collection of urine samples is in error. EPA researchers are knowledgeable about phthalate metabolism. At the time that phthalates were considered for inclusion in the study, available data were reviewed to determine if urine samples collected for measurement of pesticide metabolites could also be used for measurements of phthalate metabolites. This review indicated that the metabolism rates were similar enough for the pyrethroid pesticides and the phthalates that the sample collection protocol in the original study design was acceptable for both classes of chemicals. To address concerns of the Panel, urine samples will be collected both prior to, and following, the pesticide application. Prior to a pesticide application in the home, two urine samples will be collected ( one in the morning and one in the evening) in order to measure the background metabolite concentrations prior to a pesticide application in the home. Within 24 hours or less following a pesticide application in the home, urine sample collection will begin. The urine sample collection will be timed to be coincidental with collection of air samples, diet samples, and other environmental or personal samples in the study home. A series of four urine samples will be collected at approximately 12, 24, 36, and 48 hours after the start of collection of air and diet samples, so that the metabolite concentrations in the urine can be related to aggregate exposures estimated from the measurements of the chemicals in the environmental media. Therefore, for each data collection event, six urine samples will be collected from each child in the study, providing background data and temporal variability. Over the two year period, data collection will be performed six times for each child enrolled into the study as newborns, for a total of 36 urine samples per child during the study. The six urine samples to be collected over three days for each child during each sample collection event are substantially more than Brock et al. or CDC collected. The protocol has been designed to address deficiencies in urine sample collection protocols used in previous studies.

Panel Comment: The study design does not address potential bias due to timing of sampling with pesticide use. The timing for the samples to be analyzed for phthalates is after a pesticide use, but the study design provides no evidence of consideration of whether such timing might bias estimation of exposures to the other substances under study, including phthalates. For example, will pesticide use affect behavioral activity ( different rooms, different parental control over crawling, mouthing behavior) that could affect phthalate exposure? Are phthalates present in the pesticides being used? With respect to the last question, EPA's response is that " EPA is not attempting to identify the source of the phthalates, but the young children's aggregate exposure to them" ( Supporting Statement, p. 9). However, if all samples are taken after pesticide use, and the pesticide contains phthalates, then the resulting aggregate exposure value is going to be artificially exaggerated. EPA's Response: It is true that the timing of sample collection is related to a pesticide application in the residence. This was an essential element of the study design in order for the 8 study to meet the objectives related to measurements of exposure factors, evaluation of the impact of activity and developmental lifestage on exposure, etc. We considered this in the design of the phthalate component of the study. This element of the study design will not bias the estimates of phthalate exposures. Urine samples will be collected both before and following the pesticide application. Therefore, there will be data on the background level of phthalate metabolites in the urine prior to the pesticide application. Even if there are phthalates in the pesticides used by the occupant of the study home, this could not be considered a bias because exposure to phthalates in this consumer product ( the pesticide) should be considered part of the child's total exposure to phthalates in the home. With regard to the impact of a pesticide application on a child's behavior and activities, we will collect time/ activity data during both the pre and post application periods and will be able to evaluate whether the application affected the behavioral activity of the child. We are not attempting to " exaggerate" the exposure to phthalates, but to measure the exposures in real life situations, which include use of everyday consumer products, including pesticides.

Panel Comment: It appears there will not be appropriate questionnaires for phthalates. In its previous comments, the Panel asked whether the environmental questionnaires were appropriately designed to collect exposure information relevant to sources of phthalates. EPA's response is thus: After consultation with many government and non government researchers, the conclusion was reached that there are no validated questionnaires currently being used for exposure assessments to phthalates. However, EPA believes it critically important to use questionnaires that have been evaluated or used by other researchers. This helps in consistency of the analysis and interpretation of the data. Therefore, the questions relating to potential phthalate exposures have been taken from other researchers. ( Supporting Statement, p. 9) This response appears to be an admission that the questionnaires may not be appropriate for phthalates   certainly that they are not validated for phthalates. The EPA concludes that since no validated questionnaires are currently being used for exposure assessments to phthalates, the next best thing is to take questionnaires used in studies for other chemical exposures. This approach seems to be based on expediency and a lack of understanding of exposure to phthalates. Detailed information on use patterns, including brands, and timing in relation to exposure measurements would be needed to place results in a meaningful context. This is not being done in the proposed study. EPA's Response: The EPA's approach for this study is based on the best available information on exposure to phthalates. The Panel's insinuation that the EPA's approach is based on expediency and a lack of understanding is incorrect. The fact that there is not a validated questionnaire for phthalates suggests that information is needed to improve our understanding of exposures to phthalates and the factors that affect these exposures. The EPA reviewed a number of questionnaires that are currently being used, or have recently been used, in studies involving exposure to phthalates. The predictive value of questionnaires being used in current, or very recently completed, studies has not been validated because data analyses are not completed. Other questionnaires used in previous studies could not be validated due to inadequate study design. Knowledgeable researchers in the exposure assessment field are aware that there are few questionnaires available that have been validated to accurately predict exposure to chemicals in the environment. This is particularly true for chemicals with multiple and complex intermittent sources such as phthalates. We have developed a questionnaire that is based on the best 9 available information from academic and government researchers at this time. The fact that the questionnaire is not " validated" does not mean it is not " appropriate" for use in the study. We will be able to evaluate its predictive value from the data collected in this study. The Panel is correct that detailed information on use patterns, including brands and timing in relation to exposure measurements, is not being collected with the questionnaires. Collection of such detailed information would place too heavy of a burden on the participants in this study and was not considered to have practical utility for the study. Although this information may be useful, it is not required to meet the objectives of the study, which include estimating aggregate exposures of children to phthalates, evaluating the relationship between the biomarkers of exposure and the aggregate exposure estimates, and evaluating and apportioning the exposure pathways for selected phthalates. It is not necessary to identify the specific sources or use patterns to meet the objectives of the study. The questions included in Form # 4: Monitoring Period Questionnaire, will provide information of practical utility to address the study objectives, without placing a heavy burden on the participant.

Panel Comment: The study cannot significantly increase our understanding of phthalate exposure pathways. EPA's Supporting Statement ( p. 5) asserts that the data generated by the proposed study will: ° " estimate the aggregate exposures of a cohort of very young children to the selected phthalates in their residential environments," ° " evaluate the relationship between biomarker concentrations and exposure estimates based on measurements of the selected phthalates in environmental media and diet," and ° " evaluate and apportion the exposure pathways for the selected phthalates." However, EPA elsewhere states " EPA is not attempting to identify the source of the phthalates, but the young children's exposure to them" ( Supporting Statement, p. 9). If EPA does not identify the sources of phthalates, it is not clear how it can evaluate the relationship between biomarker concentrations and exposure estimates or evaluate and apportion the exposure pathways. The only answer apparent to the Panel is that EPA will use its measurements of phthalates in air, dust and food to estimate the exposure from each route, and will compare those estimates with the aggregate exposure indicated by the urinary metabolite measurements. As described in the Panel's previous comments ( p. 4), such work has already been accomplished by Clark et al. ( 2003a, b), who conducted a thorough literature search of information on phthalate environmental concentrations and used that information to estimate exposures of various age groups. As designed, EPA's proposed study would not be expected to provide additional significant information about exposure pathways. EPA's Response: The Panel is correct that the EPA will use the measurement data for the various media collected to assess the different routes of exposure to estimate the aggregate exposure for each child during each of the five or six data collection events over the two year study. The data collected to perform these estimates, and the algorithms used for the calculations are described in the Draft Protocol for Measuring Children's Non Occupational Exposure to Pesticides by all Relevant Pathways and shown below. 10 Summary of Data Collection Requirements by Exposure Route Parameter Measurement How Collected Units Inhalation Exposure Eime/ ma = Came x Tme/ ma x IRma Came Air concentration in me Measured with active sorbent collection µ g/ m3 Tme/ ma Time spent in each me/ ma Time activity diary, questionnaire h/ d IRma Inhalation rate Estimated from size, age, and activity data collected with diaries and questionnaires using reference values m3/ h Dermal Exposure  Macroactivity Approach Edme/ ma = Csurf x TCme/ ma x ADme/ ma Csurf Surface loading ( total or transferrable) in each me Measured by wipe, press, or roller methods µ g/ cm2 TCme/ ma Transfer coefficienta Empirically determined for each me/ ma from laboratory experiments or field studies cm2/ h ADme/ ma Activity duration for ma in a specific me Time activity diary, questionnaire h/ d Dermal Exposure  Microactivity Approach Edmi = Csurf x TE x SA x EF Csurf Surface loading ( total or transferable) in me Measured by wipe, press, or roller method µ g/ cm2 TE Transfer efficiencya Empirically determined from laboratory experiments unitless SA Surface area contacted Visual observation or videotape cm2/ event EF Frequency of contact events Visual observation or videotape events/ d Dietary Ingestion Exposure Ef =

CfWf Cf Concentration of pesticide in the food item ( s) Measurement in individual food items or composite duplicate diet samples µ g/ kg Wf Weight of food item consumed Measured in duplicate diet sample kg/ d 11 Indirect Ingestion Exposure  Microactivity Approach Eingmi = Cx x TEx x SAx x EF Csurfx Surface loading ( total or transferable) on object x Measure by a wipe or press method µ g/ cm2 TEx Transfer efficiencya Empirically determined from laboratory experiments unitless SAx Surface area contacted Visual observation or videotape cm2/ event EF Frequency of mouthing events Visual observation or videotape events/ d a This parameter must be calculated using the same surface loading measurement method as used to measure Csurf The Panel suggests that this work has already been done by Clark et al. ( 2003a, b). The work by Clark et al. is a probabilistic modeling analysis; it was not a measurement study for predicting exposures, nor were measurements conducted to verify the analysis. Physical and behavioral characteristics of receptors in various age groups were first specified. Phthalate concentrations were obtained from various databases that consisted of concentrations of six phthalate esters measured in a number of independent research and testing programs/ projects in Europe, the United States, and Japan. According to Clark et al., " The reported concentrations vary widely as a result of several factors including analytical error, sample contamination, and proximity to a variety of past and present sources." The model was used to assess the exposure from environmental sources and to apportion the pathways. Exposures from consumer products were not included in the estimates. Although food was the major route of exposure for all six phthalates, indoor air and dust ingestion were also important routes for infants and toddlers. In their discussion of the exposure assessment results, Clarke et al. made the following observations:   " Estimates of phthalate ester exposure would be improved by obtaining recent measurements of phthalate esters in a variety of foods."   " Ingestion of dust and inhalation of indoor air represent the most important nonfood sources of exposure to phthalate esters. These estimates rely heavily on European data, due to a lack of North American data."   " A link between human exposure and multimedia modeling of phthalate esters has not yet been established. This link has been difficult to estimate, for several reasons, including:

Phthalate ester exposure may arise from industrial or consumer use in addition to environmental sources;

As discussed in Chapter 5, phthalate esters appear to be metabolized as they progress up the food chain ( i. e., they biodilute), making it difficult to estimate concentrations in food from abiotic media;

Some foods that contribute significantly to human exposure are imported from outside the region being modeled. As a result, human exposure estimates will not be substantially improved by measuring phthalate ester concentrations in foods from different regions. Regional differences in exposure are more likely to be due to dietary differences ( i. e., differences 12 in ingestion rates of different foods) than in the concentrations of the phthalate esters)."

The proposed study will collect samples that address some of the issues identified by Clark et al. We will collect duplicate diet samples from the study participants. The measurement results for the actual foods that were eaten during the measurement period will be used in the aggregate exposure estimates. Indoor air samples and house dust samples will be collected during the study, filling a critical data gap identified by Clark et al. Measurements will be performed in residences where consumer products are used, addressing the potentially largest source of exposure, which the Clark et al. model did not include. Based on Clark et al.' s assessment, we believe that the data collected by EPA in this study will provide additional significant information and will address important issues raised by Clark et al. The measurement data collected in this study is important because it will be available to Clark and others for evaluating the probabilistic models used to estimate exposure.