[Federal Register Volume 77, Number 75 (Wednesday, April 18, 2012)]
[Rules and Regulations]
[Pages 23123-23125]
[FR Doc No: 2012-9389]

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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 100

[Docket No. USCG-2012-0168]
RIN 1625-AA08

Special Local Regulation; Smokin The Lake; Gulfport Lake;
Gulfport, MS

AGENCY: Coast Guard, DHS.

ACTION: Temporary final rule.

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SUMMARY: The Coast Guard is establishing a temporary special local
regulation for a portion of Gulfport Lake in Gulfport, MS. This action
is necessary for the safeguard of participants and spectators,
including all crews, vessels, and persons on navigable waters during
the Smokin The Lake high speed boat races on May 5 and 6, 2012. Entry
into, transiting or anchoring in this area is prohibited to all vessels
not registered with the sponsor as participants or not part of the
regatta patrol, unless specifically authorized by the Captain of the
Port (COTP) Mobile or a designated representative.

DATES: This rule is effective and enforceable with actual notice from
10 a.m. until 6 p.m. on May 5, 2012 and May 6, 2012.

ADDRESSES: Documents indicated in this preamble as being available in
the docket are part of docket USCG-2012-0168 and are available online
by going to http://www.regulations.gov, inserting USCG-2012-0168 in the
``Search'' box, and then clicking ``Search.'' They are also available
for inspection or copying at the Docket Management Facility (M-30),
U.S. Department of Transportation, West Building Ground Floor, Room
W12-140, 1200 New Jersey Avenue SE., Washington, DC 20590, between 9
a.m. and 5 p.m., Monday through Friday, except Federal holidays and
U.S. Coast Guard Sector Mobile (spw), Building 102, Brookley Complex,
South Broad Street, Mobile, AL 36615, between 8 a.m. and 3:30 p.m.,
Monday through Friday, except Federal holidays.

FOR FURTHER INFORMATION CONTACT: If you have questions on this
temporary rule, call or email LT Lenell J. Carson, Coast Guard Sector
Mobile, Waterways Division; telephone<PHONE_NUMBER> or email
<EMAIL_ADDRESS>If you have questions on viewing the docket,
call Renee V. Wright, Program Manager, Docket Operations, telephone
202-366-9826.

SUPPLEMENTARY INFORMATION:

Regulatory Information

    The Coast Guard is issuing this temporary final rule without prior
notice and opportunity to comment pursuant to authority under section
4(a) of the Administrative Procedure Act (APA) (5 U.S.C. 553(b)). This
provision authorizes an agency to issue a rule without prior notice and
opportunity to comment when the agency for good cause finds that those
procedures are ``impracticable, unnecessary, or contrary to the public
interest.'' This rule provides proper notice; however, under 5 U.S.C.
553(b)(B), the Coast Guard finds that good cause exists for not
publishing a notice of proposed rulemaking (NPRM) which would provide a
comment period with respect to this rule. The Coast Guard received an
application for a Marine Event Permit on February 27, 2012 confirming
that this year's occurrence of this annual event would take place on
May 5, 2012 and May 6, 2012. After reviewing the details of the event
and the permit application, the Coast Guard determined that a special
local regulation is needed and delaying or foregoing this safety
measure would be contrary to the public interest. Additionally, this
special local regulation is part of a separate rulemaking updating the
current list of annually recurring events under docket number USCG-
2011-0286. That rulemaking published March 1, 2012 in the Federal
Register (77 FR 12456) provided a comment period before becoming a
permanent final rule. No comments were received in that docket related
to this event.
    The special local regulation is needed to safeguard persons and
vessels from safety hazards associated with the Smokin The Lake high
speed boat races.

Basis and Purpose

    On February 27, 2012, Smokin The Lake applied for a Marine Event
Permit to conduct high speed boat races on Gulfport Lake, Gulfport, MS
on May 5, 2012 and May 6, 2012. This event will draw in a large number
of pleasure craft and the high speed boats pose a significant safety
hazard to both vessels and mariners operating in or near the area. The
COTP Mobile is establishing a temporary special local regulation for a
portion of Gulfport Lake, Gulfport, MS to safeguard persons and vessels
during the high speed boat races.
    The COTP anticipates minimal impact on vessel traffic due to this
regulation. However, this special local regulation is deemed necessary
for the safeguard of life and property within the COTP Mobile zone.

Discussion of Rule

    The Coast Guard is establishing a temporary special local
regulation for Gulfport Lake, Gulfport, MS to include all waters
between an eastern boundary represented by positions 30[deg]25'36'' N,
089[deg]03'08'' W to 30[deg]25'26'' N, 089[deg]03'08'' W, and a western
boundary represented by positions 30[deg]25'32'' N, 089[deg]03'59'' W
to 30[deg]25'26'' N, 089[deg]03'59'' W. This temporary rule will
safeguard life and property in this area. Entry into, transiting or
anchoring in this zone is prohibited to all vessels not registered with
the sponsor as participants or not part of the regatta patrol, unless
specifically authorized by the COTP Mobile or a designated
representative. They may be contacted on VHF-FM Channel 16 or through
Coast Guard Sector Mobile at<PHONE_NUMBER>.
    The COTP Mobile or a designated representative will inform the
public through broadcast notice to mariners of changes in the effective
period for the special local regulation. This rule is effective from 10
a.m. until 6 p.m. on May 5, 2012 and May 6, 2012.

Regulatory Analyses

    We developed this rule after considering numerous statutes and
executive orders related to rulemaking. Below we summarize our analyses
based on 13 of these statutes or executive orders.

Regulatory Planning and Review

    This rule is not a significant regulatory action under section 3(f)
of Executive Order 12866, Regulatory Planning and Review, as
supplemented by Executive Order 13563, Improving Regulation and
Regulatory Review, and does not require an assessment of potential
costs and benefits under section 6(a)(3) of Executive Order 12866 or
under section 1 of Executive Order 13563. The Office of Management and
Budget has not reviewed it under those Orders.
    The special local regulation listed in this rule will only restrict
vessel traffic from entering, transiting, or anchoring within Gulfport
Lake, Gulfport, MS. The effect of this regulation will not be
significant for several reasons: (1) This rule will only affect vessel
traffic for a short duration; (2) vessels may request permission from
the COTP to transit through the regulated area; and (3) the impacts on
routine navigation are expected to be minimal. Notifications to the
marine community will be made through broadcast notice to mariners.
These notifications will allow the public to plan operations around the
regulated area.

Small Entities

    Under the Regulatory Flexibility Act (5 U.S.C. 601-612), we have
considered whether this rule would have a significant economic impact
on a substantial number of small entities. The term ``small entities''
comprises small businesses, not-for-profit organizations that are
independently owned and operated and are not dominant in their fields,
and governmental jurisdictions with populations of less than 50,000.
    The Coast Guard certifies under 5 U.S.C. 605(b) that this rule will
not have a significant economic impact on a substantial number of small
entities. This rule will affect the following entities, some of which
may be small entities: The owners or operators of vessels intending to
transit or anchor in affected portions of Gulfport Lake during the high
speed boat races. This special local regulation will not have a
significant economic impact on a substantial number of small entities
for the following reasons. The zone is limited in size, is of short
duration and vessel traffic may request permission from the COTP Mobile
or a designated representative to enter or transit through the
regulated area.

Assistance for Small Entities

    Under section 213(a) of the Small Business Regulatory Enforcement
Fairness Act of 1996 (Pub. L. 104-121), we offer to assist small
entities in understanding the rule so that they can better evaluate its
effects on them and participate in the rulemaking process.
    Small businesses may send comments on the actions of Federal
employees who enforce, or otherwise determine compliance with, Federal
regulations to the Small Business and Agriculture Regulatory
Enforcement Ombudsman and the Regional Small Business Regulatory
Fairness Boards. The Ombudsman evaluates these actions annually and
rates each agency's responsiveness to small business. If you wish to
comment on actions by employees of the Coast Guard, call 1-888-REG-FAIR
(1-888-734-3247). The Coast Guard will not retaliate against small
entities that question or complain about this rule or any policy or
action of the Coast Guard.

Collection of Information

    This calls for no new collection of information under the Paperwork
Reduction Act of 1995 (44 U.S.C. 3501-3520).

Federalism

    A rule has implications for federalism under Executive Order 13132,
Federalism, if it has a substantial direct effect on the States, on the
relationship between the national government and the States, or on the
distribution of power and responsibilities among the various levels of
government. We have analyzed this rule under that Order and determined
that this rule does not have implications for federalism.

Protest Activities

    The Coast Guard respects the First Amendment rights of protesters.
Protesters are asked to contact the person listed in the FOR FURTHER
INFORMATION CONTACT section to coordinate protest activities so that
your message can be received without jeopardizing the safety or
security of people, places or vessels.

Taking of Private Property

    This rule will not affect a taking of private property or otherwise
have taking implications under Executive Order 12630, Governmental
Actions and Interference with Constitutionally Protected Property
Rights.

Civil Justice Reform

    This rule meets applicable standards in sections 3(a) and 3(b)(2)
of Executive Order 12988, Civil Justice Reform, to minimize litigation,
eliminate ambiguity, and reduce burden.

Protection of Children

    We have analyzed this rule under Executive Order 13045, Protection
of Children from Environmental Health Risks and Safety Risks. This rule
is not an economically significant rule and does not create an
environmental risk to health or risk to safety that may
disproportionately affect children.

Indian Tribal Governments

    This rule does not have tribal implications under Executive Order
13175, Consultation and Coordination with Indian Tribal Governments,
because it does not have a substantial direct effect on one or more
Indian tribes, on the relationship between the Federal Government and
Indian tribes, or on the distribution of power and responsibilities
between the Federal Government and Indian tribes.

Energy Effects

    This action is not a ``significant energy action'' under Executive
Order 13211, Actions Concerning Regulations That Significantly Affect
Energy Supply, Distribution, or Use.

Technical Standards

    This rule does not use technical standards. Therefore, we did not

consider the use of voluntary consensus standards.

Environment

    We have analyzed this rule under Department of Homeland Security
Management Directive 023-01 and Commandant Instruction M16475.lD, which
guide the Coast Guard in complying with the National Environmental
Policy Act of 1969 (NEPA) (42 U.S.C. 4321-4370f), and have concluded
this action is one of a category of actions which do not individually
or cumulatively have a significant effect on the human environment.
This rule is categorically excluded, under figure 2-1, paragraph
(34)(h), of the Instruction. This rule involves establishing a special
local regulation, requiring a permit wherein an analysis of the
environmental impact of the regulations was performed. Under figure 2-
1, paragraph (34)(h.), of the Instruction, an environmental analysis
checklist and a categorical exclusion determination are not required
for this rule.

List of Subjects 33 CFR Part 100

    Marine safety, Navigation (water), Reporting and recordkeeping
requirements, Waterways.

    For the reasons discussed in the preamble, the Coast Guard amends
33 CFR Part 100 as follows:

PART 100--SAFETY OF LIFE ON NAVIGABLE WATERS

0
1. The authority citation for part 100 continues to read as follows:

    Authority:  33 U.S.C. 1233.

0
2. Add Sec.  100.35T08-0168 to read as follows:

Sec.  100.35T08-0168  Special Local Regulation; Gulfport Lake;
Gulfport, MS.

    (a) Regulated Area. The following area is a regulated area:
Gulfport Lake, Gulfport, MS to include all waters between an eastern
boundary represented by positions 30[deg]25'36'' N, 089[deg]03'08'' W
to 30[deg]25'26'' N, 089[deg]03'08'' W, and a western boundary
represented by positions 30[deg]25'32'' N, 089[deg]03'59'' W to
30[deg]25'26'' N, 089[deg]03'59'' W.
    (b) Enforcement dates. This rule will be enforced from 10 a.m.
until 6 p.m. on May 5, 2012 and May 6, 2012.
    (c) Special Local Regulations.
    (1) The Coast Guard will patrol the regulated area under the
direction of a designated Coast Guard Patrol Commander. The Patrol
Commander may be contacted on Channel 16 VHF-FM (156.8 MHz) by the call
sign ``PATCOM''.
    (2) All Persons and vessels not registered with the sponsor as
participants or official patrol vessels are considered spectators. The
``official patrol vessels'' consist of any Coast Guard, state, or local
law enforcement and sponsor provided vessels assigned or approved by
the Captain of the Port Mobile to patrol the regulated area.
    (3) Spectator vessels desiring to transit the regulated area may do
so only with prior approval of the Patrol Commander and when so
directed by that officer and will be operated at a minimum safe
navigation speed in a manner which will not endanger participants in
the regulated area or any other vessels.
    (4) No spectator shall anchor, block, loiter, or impede the through
transit of participants or official patrol vessels in the regulated
area during the effective dates and times, unless cleared for entry by
or through an official patrol vessel.
    (5) The patrol commander may forbid and control the movement of all
vessels in the regulated area. When hailed or signaled by an official
patrol vessel, a vessel shall come to an immediate stop and comply with
the directions given. Failure to do so may result in expulsion from the
area, citation for failure to comply, or both.
    (6) Any spectator vessel may anchor outside the regulated area, but
may not anchor in, block, or loiter in a navigable channel. Spectator
vessels may be moored to a waterfront facility within the regulated
area in such a way that they shall not interfere with the progress of
the event. Such mooring must be complete at least 30 minutes prior to
the establishment of the regulated area and vessels must remain moored
through the duration of the event.
    (7) The Patrol Commander may terminate the event or the operation
of any vessel at any time it is deemed necessary for the protection of
life or property.
    (8) The Patrol Commander will terminate enforcement of the special
local regulations at the conclusion of the event.
    (d) Informational Broadcasts. The Captain of the Port or a
designated representative will inform the public through broadcast
notices to mariners of the enforcement period for the regulated area as
well as any changes in the planned schedule.

    Dated: March 27, 2012.
D.J. Rose,
Captain, U.S. Coast Guard, Captain of the Port Mobile.
[FR Doc. 2012-9389 Filed 4-17-12; 8:45 am]
BILLING CODE 9110-04-P


Supporting Statement for an Information Collection Request (ICR) Under the Paperwork Reduction Act (PRA)
  EXECUTIVE SUMMARY
  Identification of the Information Collection  -  Title and Numbers
      Title: Procedures for Requesting a Chemical Risk Evaluation under TSCA (Proposed Rule; RIN 2070-AK90)
        EPA ICR No.: 2781.01
        OMB Control No.: 2070-NEW
        Docket ID No.: EPA-HQ-OPPT-2023-0496
  Abstract
This ICR is related to a requirement contained in a proposed rule to implement provisions outlined in the Frank R. Lautenberg Chemical Safety of the 21[st] Century Act which passed in June 2016 and amended the Toxic Substances Control Act (TSCA). The Environmental Protection Agency (EPA) is proposing to amend the process for conducting risk evaluations under the TSCA to determine whether a chemical substance presents an unreasonable risk of injury to health or the environment under the known, intended, or reasonably foreseen conditions of use, without consideration of costs or non-risk factors, including unreasonable risk to potentially exposed or susceptible subpopulations. EPA has reconsidered the procedural framework rule for conducting such risk evaluations and determined that certain aspects of that framework should be revised to align with applicable court decisions and the statutory text, to reflect the Agency's experience implementing the risk evaluation program following enactment of the 2016 TSCA amendments, and to allow for consideration of scientific advances in the risk evaluation process without need to further amend the Agency's procedural rule. Revisions to this rule also includes changes to the process by which a manufacture may request that EPA conduct a risk evaluation on a chemical for which they manufacture. This proposed rule outlines the criteria and information chemical manufacturers must provide for EPA to consider a chemical substance for risk evaluation. Also included is Agency's process and timing to review the request to determine whether to grant or deny. The information collection activities covered by this ICR are those carried out by a chemical manufacturer in requesting a specific chemical risk evaluation under TSCA be conducted by EPA.

  Summary of Annual Burden and Costs

                                   Activity
                             Number of Respondents
                    Average Annual Responses Per Respondent
                     Average Annual Burden Per Respondent
                       Average Annual Total Labor Burden
                       Average Annual Total Labor Costs
                     Average Annual Total Non-Labor Costs
                          Average Annual Total Costs
Agency Burden
                                                                              -
                                                                              -
                                                                              -
                                                                         5,920
                                                                   $540,259.20
                                                                              -
                                                                   $540,259.20
                           Industry Burden and Cost
CDX Registration
                                                                              3
                                                                              1
                                                                           2.83
                                                                           2.83
                                                                          $268
                                                                              -
                                                                          $268
Rule Familiarization
                                                                              3
                                                                              1
                                                                              3
                                                                              3
                                                                          $284
                                                                              -
                                                                          $284
Submission Package Burden
                                                                              3
                                                                              1
                                                                            160
                                                                            160
                                                                       $15,158
                                                                      $100,000
                                                                      $115,158
All Industry Activities
                                                                              3

                                                                            166
                                                                            166
                                                                       $15,711
                                                                      $100,000
                                                                      $115,711

SUPPORTING STATEMENT

1. Explain the circumstances that make the collection of information necessary. Identify any legal or administrative requirements that necessitate the collection. Attach a copy of the appropriate section of each statute and regulation mandating or authorizing the collection of information.

Under section 6(b)(4)(B) of TSCA (15 U.S.C. §2605(b)(4)), EPA is required to establish, by rule, a process to conduct risk evaluations. Specifically, EPA is directed to use this process to "determine whether a chemical substance presents an unreasonable risk of injury to health or the environment, without consideration of costs or other non-risk factors, including an unreasonable risk to a potentially exposed or susceptible subpopulation identified as relevant to the risk evaluation by the Administrator under the conditions of use." (15 U.S.C. 85 §2605(b)(4)(A). In selecting chemicals for risk evaluation EPA is required to, through the Prioritization process, identify high-priority chemical substances for risk evaluation. Additionally, as described in Section 6(b)(4)(C)(ii) allows manufacturers of a chemical substance to request that their substance be evaluated by the Agency. The statute requires the Agency to develop a form and manner and use the criteria prescribed by the Administrator in the rule promulgated under Section 6(b)(4)(B). As required by the statute the Procedures for Chemical Risk Evaluation Under the Amended Toxic Substances Control Act was finalized June 2017.

The proposed rule amends the process by which the Agency would conduct risk evaluations on chemical substances under TSCA, including but not limited to targeted changes to certain definitions, clarifications regarding the required scope of risk evaluations, considerations related to peer review and the Agency's implementation of the scientific standards, the approach for risk determinations on chemical substances and considerations related to unreasonable risk, the process for revisiting a completed risk evaluation, and the process and requirements for manufacturers making a discretionary request for an Agency-conducted risk evaluation on a particular chemical substance.

The purpose of this revision was first in response to the court ruling on filed petitions from several non-governmental organizations for judicial review of the 2017 final rule, which were consolidated in the U.S. Court of Appeals for the Ninth Circuit under Safer Chemicals, Healthy Families v. USEPA, on August 10, 2017. The Ninth Circuit issued its opinion on November 14, 2019, holding that the EPA unlawfully excluded "legacy uses and associated disposals" from the conditions of use that the agency would consider in any risk evaluation. Specifically with respect to manufacturer requested risk evaluations, at the Agency's request, the Ninth Circuit (1) vacated and remanded the rule provisions applying criminal penalties to the submission of inaccurate or incomplete information to EPA by a manufacturer pursuant to a manufacturer-requested risk evaluation, and (2) remanded without vacatur the rule provisions addressing the information requirements for, and application of the TSCA section 26 scientific standards to, a manufacturer-requested risk evaluation.

Additionally, based on experience in implementing that process to date, EPA is proposing some modifications to increase clarity and to better position the Agency to carry out manufacturer-requested risk evaluations moving forward.

The information collection activities covered by this ICR are necessary in order for EPA to review information provided by chemical manufacturers and determine if the chemical substance is suitable for risk evaluation. Without collecting the information outlined in this proposed rule, there would not be a way for EPA to determine if enough data and information meeting the standards in section 21(h) available to perform a risk evaluation of the given chemical substance within the timeframe outlined in the new legislation.

2. Indicate how, by whom, and for what purpose the information is to be used. Except for a new collection, indicate the actual use the Agency has made of the information received from the current collection.

  EPA. This information collection provides EPA with information necessary to conduct a risk evaluation on a chemical substance and each submission request must comply with all procedures and criteria outlined in this proposed rule. A request meets EPA's criteria if it includes or references all the information necessary for the Agency to conduct a risk evaluation addressing all the circumstances constituting condition(s) of use of the chemical substance within the meaning of TSCA section 33.

  EPA uses this information collection to (1) determine if the criteria has been met for risk evaluation requests and (2) conduct the risk evaluation if the request is granted.

3. Describe whether, and to what extent, the collection of information involves the use of automated, electronic, mechanical, or other technological collection techniques or other forms of information technology, e.g., permitting electronic submission of responses, and the basis for the decision for adopting this means of collection. Also describe any consideration of using information technology to reduce burden.

  EPA makes use of existing technology to simplify the submission process. Respondents submit the initial request package and any supplemental information to the Agency via CDX. This is the same system used for section 5 submissions to EPA. Therefore, respondents may already be familiar with the system and the system has the capabilities to receive and send information claimed as CBI.

4. Describe efforts to identify duplication. Show specifically why any similar information already available cannot be used or modified for use for the purposes described in Item 2 above.

  The EPA's collection pursuant to a manufacturer requested risk evaluation under TSCA Section 6(b)(4)(C)(ii) do not duplicate any other collection. There is no other Federal program that voluntarily allows the information collection activities related to the submission under the proposed rule.

5. If the collection of information impacts small businesses or other small entities, describe the methods used to minimize burden.

 EPA believes that the submission requirements do not unduly burden small businesses. EPA concludes that the final information collection request has no significant impacts on small entities subject to this ICR as firms self-select to report and when doing so less than one percent of the small businesses in the estimated universe of those potentially impacted are expected to have an impact of greater than 3 percent.

6. Describe the consequence to Federal program or policy activities if the collection is not conducted or is conducted less frequently, as well as any technical or legal obstacles to reducing burden.

  Due to the nature of the triggering events that initiate information collection activities included in this ICR, less frequent collection is not feasible. This ICR only applies to voluntary actions by chemical manufacturers. Submission of information thus is on an as-needed, on-occasion basis, as initiated by respondents. EPA cannot control when or how often respondents elect to submit a chemical substance for risk evaluation consideration. Less frequent collection would mean respondents not being required to submit data at all. However, without such data, EPA would not be able to consider chemical substances for risk evaluation at the request of chemical manufacturers as mandated in TSCA.

7. Explain any special circumstances that require the collection to be conducted in a manner:
 requiring respondents to report information to the agency more often than quarterly;
 requiring respondents to prepare a written response to a collection of information in fewer than 30 days after receipt of it;
 requiring respondents to submit more than an original and two copies of any document;
 requiring respondents to retain records, other than health, medical, government contract, grant-in-aid, or tax records, for more than three years;
 in connection with a statistical survey, that is not designed to produce valid and reliable results that can be generalized to the universe of study;
 requiring the use of a statistical data classification that has not been reviewed and approved by OMB;
 that includes a pledge of confidentiality that is not supported by authority established in statute or regulation, that is not supported by disclosure and data security policies that are consistent with the pledge, or which unnecessarily impedes sharing of data with other agencies for compatible confidential use; or
 requiring respondents to submit proprietary trade secrets, or other confidential information unless the agency can demonstrate that it has instituted procedures to protect the information's confidentiality to the extent permitted by law.

  Not applicable.

8. If applicable, provide a copy and identify the date and page number of publication in the Federal Register of the agency's notice, required by 5 CFR 1320.8(d), soliciting comments on the information collection prior to submission to OMB. Summarize public comments received in response to that notice and describe actions taken in response to the comments. Specifically address comments received on cost and hour burden.
Describe efforts to consult with persons outside EPA to obtain their views on the availability of data, frequency of collection, the clarity of instructions and recordkeeping, disclosure, or reporting format (if any), and on the data elements to be recorded, disclosed, or reported.
Consultation with representatives of those from whom information is to be obtained or those who must compile records should occur at least once every 3 years - even if the collection of information activity is the same as in prior periods. There may be circumstances that may preclude consultation in a specific situation. These circumstances should be explained.

  The proposed rulemaking serves as the public notice for this ICR. Interested parties should submit comments referencing Docket ID No. EPA-HQ-OPPT-2023-0496 to the address listed at the end of this document. EPA will address any comments received from OMB or the public concerning the information collection activities contained in the rule, and the agency's response, when developing the final rule.

9. Explain any decision to provide any payment or gift to respondents, other than remuneration of contractors or grantees.

  This collection does not provide any payment or gift to respondents.

10. Describe any assurance of confidentiality provided to respondents and the basis for the assurance in statute, regulation, or agency policy. If the collection requires a systems of records notice (SORN) or privacy impact assessment (PIA), those should be cited and described here.

  Some portions of the information required as part of the risk evaluation request submission may be considered by the submitter to be a trade secret, proprietary, or "confidential business information" (CBI). However, EPA requires the submission of information necessary for carrying out the analysis and determining whether or not the chemical presents unreasonable risk.  EPA cannot draw conclusions or make assumptions concerning toxicological effects and potential risks without examining physicochemical structure, methods of production, byproducts, potential uses, exposure data, etc.

  The Agency's policies allow public involvement while preserving confidentiality.  TSCA section 14(a) prohibits, except in limited circumstances, the disclosure of trade secret information.  TSCA section 14(d) allows disclosure of health and safety studies, including underlying data, unless these studies disclose confidential process or mixture information. Under 40 CFR 720.85 and 720.87(See also 40 CFR part 2), when the specific chemical identity or use data are claimed confidential, the Agency requires the submitter to provide generic descriptions for inclusion in Federal Register notices and the public file.  Additionally, the submitter must provide a "sanitized" copy of all provided information, with any confidential information redacted, for placement in the public docket.  Within the Agency, only personnel with the required clearance may handle CBI.

  Based on its experience, EPA expects that some information provided in requests for risk evaluations notices will be CBI.  EPA has developed a robust system to prevent unauthorized disclosure of CBI.  This system includes procedures for logging material in and out of the Confidential Business Information Center (CBIC) at EPA headquarters and procedures for photocopying and transmitting CBI.  These procedures apply to CBI submitted by manufacturers as well as CBI generated by EPA staff in the course of their review.  Access to CBI is restricted to persons who need the information for their work.  No one is allowed access to CBI without first undergoing instruction on procedures for handling CBI.  Special procedures have been instituted to restrict access to computerized CBI.  These procedures are detailed in the "TSCA CBI Protection Manual," October 2003.  EPA believes these procedures protect confidential information while providing the public with as much information as possible.

  Any information being sent via Central Data Exchange (CDX) is transmitted using secure technologies to protect CBI.  The software encrypts company submissions using a Federal Information Processing Standards (FIPS) compliant encryption module. The encryption module employs a public key algorithm which converts readable text into encrypted text. This public key is downloaded from CDX to the submission software, and the corresponding private key is sent to EPA's New Chemical System (NCS).  The encryption remains while the submission is transmitted via CDX to NCS. The file can be decrypted only with the NCS's private key when it has reached its final destination. The NCS is the only party that possesses the private key, which converts the encrypted text back into readable text.

  The same thing will occur for all correspondence going back to the submitter.  The NCS and submission software are also provided with a set of public and private keys, so that correspondence containing any potential confidential business information will remain encrypted during transmission via CDX and can be opened only by the submitter within the appropriate software.

11. Provide additional justification for any questions of a sensitive nature, such as sexual behavior and attitudes, religious beliefs, and other matters that are commonly considered private. This justification should include the reasons why the agency considers the questions necessary, the specific uses to be made of the information, the explanation to be given to persons from whom the information is requested, and any steps to be taken to obtain their consent.

  The information collection activities do not include questions of a sensitive nature.

12. Provide estimates of the hour burden of the collection of information. The statement should:
 Indicate the number of respondents, frequency of response, annual hour burden, and an explanation of how the burden was estimated. Unless directed to do so, agencies should not conduct special surveys to obtain information on which to base hour burden estimates. Consultation with a sample (fewer than 10) of potential respondents is desirable. If the hour burden on respondents is expected to vary widely because of differences in activity, size, or complexity, show the range of estimated hour burden, and explain the reasons for the variance. Generally, estimates should not include burden hours for customary and usual business practices.
 If this request for approval covers more than one form, provide separate hour burden estimates for each form and aggregate the hour burdens.
 Provide estimates of annualized cost to respondents for the hour burdens for collections of information, identifying and using appropriate wage rate categories. The cost of contracting out or paying outside parties for information collection activities should not be included here. Instead, this cost should be included under `Annual Cost to Federal Government'.

Manufacturer requested risk evaluation requests must include all of the following information:
	(1) Name, mailing address, and contact information of the entity (or entities) submitting the request. If more than one manufacturer submits the request, all individual manufacturers must provide their contact information.
	(2) The chemical identity of the chemical substance that is the subject of the request. At a minimum, this includes: all known names of the chemical substance, including common or trades names, CAS number, and molecular structure of the chemical substance.
	(3) For requests pertaining to a category of chemical substances, an explanation of why the category is appropriate under 15 U.S.C. 2625(c). EPA will determine whether the category is appropriate for risk evaluation as part of reviewing the request in paragraph (e) of this section.
	(4) A description of the circumstances under which the chemical substance is intended, known, or reasonably foreseen to be manufactured, processed, distributed in commerce, used, or disposed of, and all information that supports the requesting manufacturer's identification of the circumstances described in this paragraph (c)(4).
	(5) All information known to or reasonably ascertainable by the requesting manufacturer on the health and environmental hazard(s) of the chemical substance, human and environmental exposure(s), and exposed population(s), including but not limited to:
      (i) The chemical substance's exposure potential, including occupational, general population and consumer exposures, and facility release information;
      (ii) The chemical substance's hazard potential, including all potential environmental and human health hazards;
	(iii) The chemical substance's physical and chemical properties.
      (iv) The chemical substance's fate and transport properties including persistence and bioaccumulation;
      (v) Potentially exposed or susceptible subpopulations which the manufacturer(s) believes to be relevant to the EPA risk evaluation;
      (vi) Whether there is any storage of the chemical substance near significant sources of drinking water, including the storage facility location and the nearby drinking water source(s);
	(vii) The chemical substance's production volume or significant changes in production volume; and
      (viii) Any other information relevant to the hazards, exposures and/or risks of the chemical substance.
	(6) Where information described in paragraph (c)(4) or (5) of this section is unavailable, an explanation as to why, and the rationale for why, in the requester's view, the provided information is nonetheless sufficient to allow EPA to complete a risk evaluation on the chemical substance.
	(7) Copies of all information referenced in paragraph (c)(5) of this section, or citations if the information is readily available from public sources.
	(8) A signed certification that all information contained in the request is accurate and complete, as follows:
	(i) I certify that to the best of my knowledge and belief:
            (A) The company named in this request manufactures the chemical substance identified for risk evaluation.
            (B) All information provided in the request is complete and accurate as of the date of the request.
            (C) I have either identified or am submitting all information in my possession and control, and a description of all other data known to or reasonably ascertainable by me as required under this part. I am aware it is unlawful to knowingly submit incomplete, false and/or misleading information in this request and there are significant criminal penalties for such unlawful conduct, including the possibility of fine and imprisonment.
      (9) Where appropriate, information that will inform EPA's determination as to whether restrictions imposed by one or more States have the potential to have a significant impact on interstate commerce or health or the environment, and that as a consequence the request is entitled to preference pursuant to 15 U.S.C. 2605(b)(4)(E)(iii).

Number of Entities Affected

EPA developed estimates for number of manufacturers who are likely to elect to submit a chemical substance for risk evaluation. Submissions of this nature are still relatively new and EPA has only received few requests from manufacturers for risk evaluations. This rule and ICR assumes 1 chemical manufacture may submit requests to the Agency in any given year which aligns with the assumptions in the current Fees Rule. The total number of entities affected by the recordkeeping and reporting requirements of the rule, therefore, is estimated to be 1 chemical manufacturer per year for a total of 3 respondents over the ICR reporting cycle.

Rule Familiarization Burden

EPA assumes that each manufacturer who elects to submit a chemical substance for risk evaluation consideration is assumed to spend 3 hours becoming familiar with the requirements of the rule and developing an understanding of what actions are necessary to complete the forms and submission package.

CDX Electronic Reporting Burden

Manufacturers requesting a chemical substance be considered by EPA for risk evaluation are required to provide the submission package to the Agency via the CDX electronic system. While several manufacturers may be familiar with the CDX system and are registered users because the same system is used for new chemical submissions to the Agency (e.g., pre-manufacture notice, significant new use notice, low volume exemptions) there is no way to estimate which manufacturers submitting risk evaluation requests are familiar with CDX and which are new to the system. Therefore, EPA assumes submissions under this information collection are performed by new users of CDX which may result in an overestimate of burden.

The CDX electronic reporting burden includes registration to CDX, familiarization with the subscriber agreements, potential use of the help desk, and problem resolution. The burden estimates used in this ICR are based off of estimates in EPA ICR No 2502.02, resulting in a burden of 2.83 hours per respondent.

Submission Package Burden

Chemical manufacturers electing to request EPA consider a chemical substance for risk evaluation must provide a submission package including the following information: contact information of requesting entity(s), full chemical identity information, complete list of reasonably available information consistent with TSCA section 26(h) standards that is relevant to an unreasonable risk determination, addresses all the circumstances that constitute conditions of use, within the meaning of TSCA section 3, and provide a signed certification that all information in the submission is accurate and complete.

While there have been a limited number of submissions to EPA under the previous Risk Evaluation Rule, the Agency has reviewed those activities and considered the additional requirements in the current proposed rule in determining the estimated burden and cost per submission. EPA estimates the cost of having a contractor conduct an in-depth literature review and screen the literature found for relevance costs an average of $100,000 per chemical. In addition to the contractor cost, the manufacturer is expected to spend an average of 160 hours per chemical reviewing the data found during the literature, refining the searches as needed, and preparing the submission package. Therefore, the estimated burden for developing and submitting a risk evaluation request is 160 hours per respondent with an additional direct cost of $100,000 per submission package. Both the number of hours and direct cost per respondent were doubled from the previous Risk Evaluation Rule ICR estimates.

Costs
EPA assumes a direct cost of $100,000 per submission package for work performed by a contractor to assist the manufacturer in preparation activities such as literature reviews. Any fees to be collected as part of the risk evaluation requests will be covered under the fees rule required by TSCA and accompanying ICR. Labor costs are based on fully loaded wage rates. The estimated wage for managerial professional (in the instance of this ICR a toxicologist) is $94.74 per hour. The table below presents the labor rates used to estimate the costs of the labor burdens under the ICR.

Loaded Industry Wage Rates, December 2022
Labor Category
Data Source
Date (mm/yy)
Wage
Fringe Benefit
Total Comp.
Over-head % Total Comp.1
Over-head
Loaded Wages2

(a)
(b)
(c)= (a)+(b)
(d)
(e)=(c)* (d)
(f)=(c)+ (e)
Managerial
BLS ECEC, Private Manufacturing industries, "Mgt, Business, and Financial"[3]
12/22
$54.29
$24.66
$78.95
20%
15.79
$94.74
Note(s):
1 An overhead rate of 20% is used based on assumptions in Handbook on Valuing Changes in Time Use Induced by Regulatory Requirements and Other U.S. EPA Actions (U.S. Environmental Protection Agency (EPA) 2020a).
2 Wage data are rounded to the closest penny; however, unrounded values were used in calculations.
[3] U.S. Bureau of Labor Statistics (BLS) 2023b

  The table below presents the summary of the average annual burden hours and costs per respondent.

Summary of Three Year Average Incremental Burden Hours and Costs for Primary Option
Activity
Number of Respondents
Average Annual Responses Per Respondent
Average Annual Burden Per Respondent
Average Annual Labor Cost Per Respondent
Average Annual Non-Labor Cost Per Respondent
Average Annual Total Labor Burden
Average Annual Total Labor Costs
Average Annual Total Non-Labor Costs
CDX Registration
3
1
2.83
$268
-
2.83
$268
-
Rule Familiarization
3
1
3
$284
-
3
$284
-
Submission Package Burden
3
1
160
$15,158
$100,000
160
$15,158
$100,000
All Activities
3
1
166
$15,711
$100,000
166
$15,711
$100,000

13. Provide an estimate for the total annual cost burden to respondents or recordkeepers resulting from the collection of information. (Do not include the cost of any hour burden already reflected on the burden worksheet).
 The cost estimate should be split into two components: (a) a total capital and start-up cost component (annualized over its expected useful life) and(b) a total operation and maintenance and purchase of services component. The estimates should take into account costs associated with generating, maintaining, and disclosing or providing the information. Include descriptions of methods used to estimate major cost factors including system and technology acquisition, expected useful life of capital equipment, the discount rate(s), and the time period over which costs will be incurred. Capital and start-up costs include, among other items, preparations for collecting information such as purchasing computers and software; monitoring, sampling, drilling and testing equipment; and record storage facilities.
 If cost estimates are expected to vary widely, agencies should present ranges of cost burdens and explain the reasons for the variance. The cost of purchasing or contracting out information collections services should be a part of this cost burden estimate. In developing cost burden estimates, agencies may consult with a sample of respondents (fewer than 10), utilize the 60-day pre-OMB submission public comment process and use existing economic or regulatory impact analysis associated with the rulemaking containing the information collection, as appropriate.
 Generally, estimates should not include purchases of equipment or services, or portions thereof, made: (1) prior to October 1, 1995, (2) to achieve regulatory compliance with requirements not associated with the information collection, (3) for reasons other than to provide information or keep records for the government, or (4) as part of customary and usual business or private practices.

    Not applicable.

14. Provide estimates of annualized cost to the Federal government. Also, provide a description of the method used to estimate cost, which should include quantification of hours, operational expenses (such as equipment, overhead, printing, and support staff), and any other expense that would not have been incurred without this collection of information. Agencies may also aggregate cost estimates from Items 12, 13, and 14 in a single table.

  EPA estimates costs of $1,620,778 to carry out the activities associated with the information collection activities covered by this ICR, the costs for the Agency to review and determine completeness of 3 manufacturer requested risk evaluations. In order to determine the total cost for the Agency, an average number of labor hours per submission package were estimated. The labor rate was assumed to be a fully loaded GS-13, step 5 employee in the Washington D.C. area of $91.26 per hour. This cost includes an average labor time of 5,920 hours per chemical submitted by a manufacturer.
15. Explain the reasons for any program changes or adjustments reported in hour or cost burden.

  This is a new, rule-related information collection. Therefore, the reported burden reflects a program change.

16. For collections whose results will be published, outline the plans for tabulation and publication. Address any complex analytical techniques that will be used. Provide the time schedule for the entire project, including beginning and ending dates of the collection of information, completion of report, publication dates, and other actions.
  Not applicable.

17. If seeking approval to not display the expiration date for OMB approval of the information collection, explain the reasons why display would be inappropriate.

  Not applicable.

18. Explain each exception to the certification statement identified in "Certification for Paperwork Reduction Act Submissions."

  EPA does not request an exception to the certification of this information collection.

SUPPLEMENTAL INFORMATION
   This collection of information is approved by OMB under the Paperwork Reduction Act, 44 U.S.C. 3501 et seq. (OMB Control No. 2070-NEW). Responses to this collection of information are mandatory for certain persons, as specified at 40 CFR 702. An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number. The public reporting and recordkeeping burden for this collection of information is estimated to be approximately 166 hours per response on average. Send comments on the Agency's need for this information, the accuracy of the provided burden estimates and any suggested methods for minimizing respondent burden to the Regulatory Support Division Director, U.S. Environmental Protection Agency (2821T), 1200 Pennsylvania Ave., NW, Washington, D.C. 20460. Include the OMB control number in any correspondence. Do not send the completed form to this address.

  To comment on the Agency's need for this information, the accuracy of the provided burden estimates, and any suggested methods for minimizing respondent burden, including the use of automated collection techniques, EPA has established a public docket for this ICR under Docket ID Number EPA-HQ-OPPT-2023-0496, which is available at http://www.regulations.gov. This site can be used to submit or view public comments, access the index listing of the contents of the public docket, and to access those documents in the public docket that are available electronically. When in the system, select "search," then key in the Docket ID Number identified above.
  You can also provide comments to the Office of Information and Regulatory Affairs, Office of Management and Budget via http://www.reginfo.gov/public/do/PRAMain. Find this particular information collection by selecting ``Currently under Review --  Open for Public Comments'' or by using the search function.

  All comments received by EPA will be included in the docket without change, including any personal information provided, unless the comment includes profanity, threats, information claimed to be Confidential Business Information (CBI), or other information whose disclosure is restricted by statute. Do not submit electronically any information you consider to be CBI or other information whose disclosure is restricted by statute.

LIST OF ATTACHMENTS
  The attachments listed below can be found in the docket for this ICR or by using the hyperlink that is provided in the list below. The docket for this ICR is accessible electronically through http://www.regulations.gov using Docket ID Number: EPA-HQ- OPPT-2023-0496.
 Ref.
 Title (hyperlink)
 1.
 TSCA section 6 (15 U.S.C. 2605)
 2.
 Proposed Rule