however ``transport'' has been added to the final text. Fate and
transport in environmental media are commonly assessed together, and
this is more consistent with EPA's current practices. EPA has also
added a statement in the rule text regarding the use of best available
science and weight of scientific evidence approaches. As stated
elsewhere in the preamble, EPA is committed to upholding these
statutory requirements.
    An exposure assessment includes some discussion of the size,
nature, and types of individuals or populations exposed to the agent,
as well as discussion of the uncertainties in this information.
Exposure can be measured directly, but when data is unavailable it is
estimated indirectly through consideration of measured concentrations
in the environment, consideration of models of chemical transport and
fate in the environment, and estimates of human intake or environmental
exposure over time. A number of commenters encouraged the use of
probabilistic approaches as they provide better estimates of exposure
when compared to specific ``bright line'' approaches. In response EPA
will strive to utilize probabilistic approaches for exposure
assessments included in a risk evaluation but has not revised the
proposed regulation, consistent with its approach to other provisions,
where EPA has moved many of the specific approaches that appeared in
the proposed rule text into the final preamble. EPA believes that this
level of detail regarding the specific information types used in risk
evaluation is more appropriate for guidance. Commenters had also
suggested that guidance is more appropriate for specific methods and
approaches because it can be amended easily to adopt to changing
science. Codifying specific methods could unnecessarily restrict the
Agency's ability to review all pertinent information.
    Using reasonably available information, exposures will be estimated
(usually quantitatively) for the identified conditions of use. For
human health exposure, the assessment would consider all potentially
exposed or susceptible subpopulation(s) identified in the scope and
utilize any combination, as available, of population-based
epidemiological studies, information related to

geographic location of susceptible subpopulations, models representing
exposures to the population, measurements in human tissues or relevant
environmental or exposure media, and any other relevant, scientifically
valid information or methodology. In an environmental health exposure
assessment the interaction of the chemical substance with any
ecological characteristics identified in the scope will be
characterized and evaluated. As with the hazard assessment, specific
details on the source of information EPA will use have been moved to
this preamble to allow for flexibility in identifying the appropriate
sources of information.
    4. Risk characterization. TSCA requires that a risk evaluation
``integrate and assess available information on hazards and
exposures.'' (15 U.S.C 2605(b)(4)(F)). A risk characterization conveys
the risk assessor's judgment as to the nature and presence or absence
of risks, along with information about how the risk was assessed, where
assumptions and uncertainties still exist, and where policy choices
will need to be made. Risk characterization takes place for both human
health risk assessments and ecological risk assessments. The proposed
text only included the necessity for EPA to describe whether aggregate
or sentinel exposures were considered during the risk evaluation and
the basis for that consideration. The final rule text was amended to
include all of the statutory requirements of the risk evaluation
process, including: Not considering costs or other non-risk factors;
taking into account the likely duration, intensity, frequency, and
number of exposures under the condition(s) of use; and a description of
the weight of scientific evidence for the identified hazards and
exposures. The statute requires a risk evaluation to include all of
these components, so EPA believed it was necessary to codify them all,
rather than to single out just one of the requirements.
    In the risk characterization summary, EPA will further carry out
the obligations under TSCA section 26; for example, by identifying and
assessing uncertainty and variability in each step of the risk
evaluation, discussing considerations of data quality such as the
reliability, relevance and whether the methods utilized were reasonable
and consistent, explaining any assumptions used, and discussing
information generated from independent peer review. 15 U.S.C. 2625(h).
EPA may include a discussion of alternative interpretations, where
these interpretations are plausible, of results generated from the risk
evaluation. EPA amended the regulation text to include the phrase
``where these interpretations are plausible,'' because EPA believes, in
agreement with a commenter, that through the use of best available
science and weight of scientific evidence approaches, it is feasible
that not every risk evaluation will have alternative interpretations.
EPA wants to be clear that alternative interpretations will be
presented in the risk characterization on a case-by-case basis, but may
not be the norm, as requested by another commenter.
    For environmental evaluations specifically, EPA plans to include a
discussion of the nature and magnitude of the effects, the spatial and
temporal patterns of the effects, implications at the species,
population, and community level, and the likelihood of recovery
subsequent to exposure to the chemical substance. A few commenters
suggested that when conducting an ecological risk assessment, it is
important to consider the population level, as this was not included in
the proposed rule. The commenters' suggestion more accurately reflects
EPA's general practices for ecological risk assessments and this change
has been made in the final rule.
    In practice, each component of the risk assessment (e.g., hazard
assessment, dose-response assessment, exposure assessment) has an
individual characterization written to carry forward the key findings,
assumptions, limitations, and uncertainties. The set of these
individual characterizations provide the information basis to write an
integrative risk characterization analysis. The final, overall risk
characterization thus consists of the individual component
characterizations plus an integrative analysis. Each risk evaluation
will quantitatively and/or qualitatively estimate and characterize risk
for the identified populations and ecological characteristics under the
conditions of use.
    EPA has historically used a MOE approach in risk characterization
of TSCA risk assessments. The proposed rule asked the public to comment
on the strengths and weaknesses of the MOE approach. EPA received many
comments with thoughtful reasoning both for and against using this
approach. As discussed by commenters, the benefits of the MOE approach
include the assertion that the approach is more transparent than other
approaches, such as a hazard index or hazard quotient, because the
application of uncertainty factors is transparent, and that the MOE
approach can incorporate data from multiple pathways and endpoints.
Some supporters of the MOE approach did encourage EPA to not prescribe
a single value that would be used for all risk evaluations, but to
select a MOE value that is fit-for-purpose and specifically associated
with the evidence of the evaluation.
    Commenters that were not supportive of this approach expressed
their concern for this ``bright line'' approach, in that it does not
reflect knowledge about what the potential risks are above or below the
`line,' and that it assumes a safe level of exposure below which harm
will not occur. Others commented that the MOE approach is not always
easily communicated to the public. Many commenters suggested
alternatives, including the use of probabilistic approaches, arguing
that they better account for variability and uncertainty. Finally,
others commented that it was not appropriate to call out specific
methods, as this is more appropriate for guidance.
    Agreeing with the consensus from the comments, EPA acknowledges
that MOE is just one of many ways to characterize risk. There will be
risk scenarios where one approach may be better than another, and as
commenters correctly pointed out, the science of risk characterization
is still evolving, particularly for non-cancer hazards. To account for
the number of different approaches and for changing science, EPA will
not codify any specific method in this final rule.
    Finally, EPA will utilize EPA's Information Quality Guidelines in
the risk characterization section of the risk evaluation, as it
provides guidance for presenting risk information (Ref. 5). As
explained in that document, EPA should identify: (1) Each population
addressed by an estimate of applicable risk effects; (2) the expected
risk or central estimate of risk for the potentially exposed or
susceptible subpopulations affected; (3) each appropriate upper-bound
or lower-bound estimate of risk; (4) each significant uncertainty
identified in the process of the assessment of risk effects and the
studies that would assist in resolving the uncertainty; and (5) peer-
reviewed studies known to the Agency that support, are directly
relevant to, or fail to support any estimate of risk effects and the
methodology used to reconcile inconsistencies in the scientific
information.
    5. Peer review. For each risk evaluation conducted on chemicals
identified pursuant to TSCA section 6(b)(4)(A), EPA will conduct a peer
review using the guidance provided in executive branch peer review
directives, including in the Office of Management and Budget Final
Information Quality

Bulletin for Peer Review (OMB Bulletin) (Ref. 18) and in the EPA Peer
Review Handbook (2015) (Ref. 19) or its updates. For those conditions
of use that may receive an early determination of no unreasonable risk,
EPA will ensure that the risk assessments underlying these
determinations are reviewed in a manner consistent with the OMB
Bulletin and the EPA Peer Review Handbook. These documents do provide
some latitude for the type of peer review that EPA can conduct, which
EPA will take advantage of. For example, in determining the appropriate
type of peer review, EPA can consider the complexity of the information
and any prior peer review of underlying information. EPA may also
utilize the SACC in reviewing the science that underlies these
determinations.
    As discussed in the proposed rule, EPA will identify aspects of the
analysis on which peer review will be conducted, and the planned
methodologies, as part of the draft scoping document that will undergo
public comment for each chemical substance that undergoes risk
evaluation. These may include novel models or analyses that warrant an
in-depth peer review. In addition to any targeted peer review of
specific aspects of the analysis, the entire risk assessment will also
undergo peer review, as it is important for peer reviewers to consider
how the various underlying analyses fit together to produce an
integrated risk characterization, which will form the basis of an
unreasonable risk determination. A number of commenters argued for
involvement of the public into the peer review process. To respond to
this, EPA plans to take public comment on the charge questions given to
peer reviewers.
    The peer review will address aspects of the science underlying the
assessment, including, but not limited to hazard assessment, assessment
of dose-response, exposure assessment, and risk characterization.
Consistent with the proposed rule, EPA will not seek review of any
determination as to whether the risks are ``unreasonable,'' which is an
Agency policy determination. EPA did receive public comment requesting
that the risk determination also be subject to peer review; however,
EPA strongly believes that the purpose of peer review is for the
independent review of the science underlying the risk assessment, not
an evaluation of EPA's policy determinations. TSCA expressly reserves
to the Agency the final determination of whether risk posed by a
chemical substance is ``unreasonable.'' 15 U.S.C. 2605(i). EPA
nevertheless will include its risk determination as part of the risk
evaluation that is subject to public review and comment.
    EPA specifically requested public comment on whether there are
circumstances where conducting peer review may not be warranted, (e.g.,
what circumstances may require peer review and if there are others that
may not) and whether the regulatory text should be adjusted to require
EPA to make a case by case determination of whether and to what extent,
consistent with the EPA Peer Review Handbook, peer review is warranted
for the chemical substance undergoing a risk evaluation. The comments
received were generally very supportive of conducting a peer review on
all risk evaluations. There were some comments that encouraged
discretion as to whether peer review had to be conducted on a
particular risk evaluation (e.g., determinations of no unreasonable
risk, or on evaluations were the result was consistent with other
national or international conclusions). Commenters also raised issues
regarding the timing of peer review in the risk evaluation process
(e.g., after public comment), what should and should not be included in
peer review (e.g., the risk determination), and views on what type of
peer review should be conducted (e.g., full panel review). EPA's
responses to specific comments are addressed in the response to comment
document.
    Accordingly, EPA has retained the provision from the proposed rule
requiring peer review on all risk evaluations. Guidance on how peer
review will be conducted will remain consistent with the EPA Peer
Review Handbook. For clarity, EPA did move the peer review provision to
its own section of the rule, as suggested by a commenter. EPA agrees
with comments that peer reviewed evaluations will instill greater
confidence and provide transparency to the process. EPA postulated in
the proposed rule that there may be circumstances that may not
necessitate peer review (e.g., where a chemical substance is found to
not present an unreasonable risk or that findings are similar or the
same as other jurisdictions (states or countries) that have reached
similar conclusions based on the same information). Public comment
presented arguments to why this is not appropriate. Although a
substance may not present an unreasonable risk, the consequence of a
`false negative' could be extremely problematic. For the second
scenario where EPA's results may be similar to another jurisdiction's,
commenters argued that it will also be necessary to peer review the
evaluation. It would be necessary to make certain the best available
science and weight of the scientific evidence approaches were used
properly, as they may not have been required under the process by which
the comparable evaluation was conducted. As such, EPA will require peer
review on all risk evaluations.
    6. Unreasonable risk determination. The final step of a risk
evaluation is for EPA to determine whether the chemical substance,
under the conditions of use, presents an unreasonable risk of injury to
health or the environment. EPA will make individual risk determinations
for all uses identified in the scope. This part of the regulation is
slightly amended from the proposed rule, to clarify that the risk
determination is part of the risk evaluation, as well as to account for
the revised approach to that ensures each condition of use covered by
the risk evaluation receives a risk determination. Due to EPA's
decision to allow for early determinations on one or more conditions of
use, where appropriate, risk determinations may be published in
multiple documents or in a single document containing all risk
determinations for all identified uses. If the determinations are
published in multiple documents, the final determination will be a
composite document of all determinations made. EPA's determinations
will specify whether each condition of use identified for a chemical
substance does or does not present an unreasonable risk of injury to
health or the environment. A determination that a condition of use does
not present an unreasonable risk is considered to be a final EPA
action. If EPA determines that the chemical substance, under one or
more condition of use, does present an unreasonable risk, EPA must
initiate a rulemaking pursuant to TSCA section 6(a) to impose
requirements to the extent necessary so that the substance no longer
presents such risk. 15 U.S.C. 2605(a). Any rule would apply only to the
condition(s) of use that present an unreasonable risk, and those that
do not present an unreasonable risk will not be subject to risk
management. A number of commenters asked EPA to communicate clearly
which uses may go to risk management following the evaluation. EPA will
clarify in the draft and final risk evaluation documents specifically
which condition(s) of use warrant risk management and which do not.
    7. Reassessment of unreasonable risk determination. EPA stated in
the proposed rule that it may reassess determinations of unreasonable
risk. A number of commenters requested clarification on when and how
this

might happen. Following review of the comments, EPA has deleted the
provision as it was unnecessary. Generally, agencies are authorized to
revisit determinations they are charged by statute to make, and nothing
in TSCA prevents EPA from doing that. EPA is also concerned that the
provision could have been read as an effort to limit, expand, or
otherwise alter the statutory authority.
    8. Additional publicly available information. Pursuant to TSCA
section 26(j), and subject to TSCA section 14, the final regulation
specifies that EPA will make available: (1) The draft scope, final
scope, draft risk evaluation, and final risk evaluation; (2) All
notices, determinations, findings, consent agreements, and orders; (3)
Any information required to be provided to the Agency under 15 U.S.C.
2603; (4) A nontechnical summary of the risk evaluation; (5) A list of
the studies, with the results of the studies, considered in carrying
out each risk evaluation; (6) Each determination as to whether the
chemical substance presents an unreasonable risk under one or more
conditions of use, along with an identification of the information,
analysis, and basis used to make the designation; (7) The final peer
review report, including the response to peer review and public
comments received during peer review; and (8) Response to public
comments received on the draft scope and the draft risk evaluation. In
this final rule there are a few slight changes from the proposed
regulation, largely to conform to changes made to other sections of the
rule. The final rule now includes number 6, which has been slightly
amended from the statute to make clear that EPA will be making public
its risk determinations (the statute uses the term ``designations'').
In addition, the final regulation now specifies and that these
determinations will be made for the chemical under the one or more
conditions of use identified in the risk evaluation.

IV. Summary of Request for Specific Public Comment on the Proposed Rule

    In the Proposed Risk Evaluation Rule, EPA requested specific public
input on a number of subjects. These subjects are listed below along
with reference of the particular section where EPA has discussed the
public comment.
    1. Redefining scientific terms. Unit III.D.
    2. Margin of Exposure. Unit III.D.13.
    3. Systematic Review. Unit III.D.12.
    4. Manufacturer requests. Unit II.A.2.
    5. Peer Review. Unit III.G.5.
    6. Reliance on existing guidance and procedures for conducting risk
evaluations. Unit III.G.1.a.
    7. Interagency collaboration. Unit III.H.

V. Cost Analysis

    Industry costs for this rule are limited to activities a
manufacturer must perform in order to meet the requirements outlined in
previous sections. Manufacturers are not required to submit a chemical
substance for risk evaluation, therefore these costs will only be
experienced when a given manufacturer chooses to make a submission to
the Agency. The fully loaded wage rate of a technical professional
(i.e., toxicologist) of $78.40 was used to calculate the cost of labor
burden.

A. Number of Entities Affected

    EPA developed estimates for the number of manufacturers who are
likely to elect to submit a chemical substance for risk evaluation.
Since submissions of this nature have never been collected by the
Agency before, the actual number of expected submittals is relatively
unknown. However, EPA assumes 5 chemical manufacturers may submit
requests to the Agency in any given year. The Agency will not be
required to perform 20 risk evaluations at any given time until 2 years
after rule finalization. Based on this, assuming 25 percent of total
risk evaluations coming from manufacturer submissions was considered a
best estimate with the lack of actual data. The total number of
entities affected by the recordkeeping and reporting requirements of
the rule, therefore, is estimated to be 5 chemical manufacturers per
year.

B. Rule Familiarization Burden

    EPA assumes that each manufacturer who elects to submit a chemical
substance for risk evaluation consideration is assumed to spend one
hour becoming familiar with the requirements of the rule and developing
an understanding of what actions are necessary to complete the forms
and submission package. This is separate from the time it takes to
create the submission package itself.
    The total cost of rule familiarization is estimated to be $392 per
year (5 x 1 x 78.40 = 392).

C. 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 rule 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
rule are based off of estimates in EPA ICR No. 2502.02, resulting in a
burden of 2.83 hours per respondent.
    The total cost of CDX electronic reporting burden is estimated to
be $1,109 per year (5 x 2.83 x 78.40 = 1,109).

D. 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, of
interest to the manufacturer, within the meaning of TSCA section 3,
contain a commitment to provide EPA any referenced information upon
request of the Agency, and provide a signed certification that all
information in the submission is accurate and complete.
    While submissions of this nature have never been required or
requested by EPA in the past, the Agency has performed similar tasks
internally while conducting previous Risk Evaluations. The average
contractor expense and labor time the Agency spends on the types of
activities required to prepared the submission package covered by this
rule were used to develop the burden and cost estimates.
    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 $50,000 per chemical. This includes the cost of using
literature review databases and the contractor labor time involved in
performing the review and screening activities. In addition to the
contractor cost, the

manufacturer is expected to spend an average of 80 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 80 hours per respondent with an additional direct cost of
$50,000 per submission package.
    Total cost for submission package burden is estimated to be
$281,360 per year (5 x 50,000 x 80 x 78.40 = 281,360).

E. Total Cost

    The total annual cost for this rule is estimated to be $282,861 per
year (392 + 1,109 + 281,360 = 282,861) under the assumption EPA
receives 5 manufacturer requests per year. Manufacturers choosing to
submit a chemical substance for risk evaluation may be a small entity.
Due to the low cost ($56,572) of a single submission package, the cost
of the voluntary submission is expected to impact less than 1% of the
small business at greater than 3% of average revenue in the estimated
universe of small businesses.

VI. References

    The following is a listing of the documents that are specifically
referenced in this document. The docket includes these documents and
other information considered by EPA, including documents that are
referenced within the documents that are included in the docket, even
if the referenced document is not physically located in the docket. For
assistance in locating these other documents, please consult the
technical person listed under FOR FURTHER INFORMATION CONTACT.

1. USEPA. Information Collection Request (ICR) for the Proposed
Rule: Procedures for Chemical Risk Evaluation Under TSCA. EPA ICR
No.: 2559.01 and OMB No. 2070--[NEW].
2. EPA. TSCA Work Plan Chemical Assessments: 2014 Update-Final.
Office of Pollution Prevention and Toxics. October 2014. https://www.epa.gov/sites/production/files/2015-01/documents/tsca_work_plan_chemicals_2014_update-final.pdf.
3. EPA. Framework for Metals Risk Assessment of the Office of the
Science Advisor, Risk Assessment Forum. Washington, DC. March 2007.
4. USEPA. Exposure Factors Handbook. EPA/600/R-090/052F. Office of
Research and Development, National Center for Environmental
Assessment. Washington, DC. 2011. https://cfpub.epa.gov/ncea/risk/recordisplay.cfm?deid=236252.
5. Guidelines for Ensuring and Maximizing the Quality, Objectivity,
Utility, and Integrity of Information Disseminated by the
Environmental Protection Agency. EPA/260R-02-008. Washington, DC.
2002. https://www.epa.gov/sites/production/files/2015-08/documents/epa-info-quality-guidelines.pdf.
6. European Centre for Ecotoxicology and Toxicology of Chemicals
(ECETOC). Targeted Risk Assessment User Guide. version 3.1. June
2014. http://www.ecetoc.org/wp-content/uploads/2014/06/Ecetoc_Tra_Standalone_Consumer_Tool_User_Guide_Jun2014.pdf.
7. Toxicology Excellence for Risk Assessment (TERA). Complex
Exposure Tool (ComET) Meeting Materials. 2009. http://www.tera.org/Peer/Exposure/ExposureMeetingMaterials.htm.
8. USEPA. Framework for Human Health Risk Assessment to Inform
Decision Making. EPA/100/R-14/001 Office of the Science Advisor,
Risk Assessment Forum. 2014. https://archive.epa.gov/raf/web/pdf/hhra-framework-final-2014.pdf.
9. National Research Council. Science and Decisions: Advancing Risk
Assessment. The National Academies Press. Washington, DC. 2009.
10. USEPA. Weight of Evidence in ecological risk assessment. Office
of Research and Development. Washington, DC. 2016.
11. Institute of Medicine. Finding What works in Health Care:
Standards for Systematic Reviews. p. 13-34. The National Academies
Press. Washington, DC. 2011.
12. J. Higgins and S. Green. Cochrane Handbook for Systematic
Reviews of Interventions. John Wiley & Sons. 2011.
13. National Research Council. Review of EPA's Integrated Risk
Information System (IRIS) Process. Board on Environmental Studies
and Toxicology. Washington, DC. 2014.
14. Stephens, M.F., Betts, K., Beck, N.B., Cogliano, V., Dickersin,
K., Fitzpatrick S., Freeman, J., Gray, G., Hartung T., McPartland,
J., Rooney A.A., Scherer R.W., Verloo, D., Hoffmann, S. The
Emergence of Systematic Review in Toxicology. Toxicological
Sciences. 152 (1): 10-16. 2016. DOI: https://doi.org/10.1093/toxsci/kfw059.
15. USEPA. Risk Assessment Guidelines. https://www.epa.gov/risk/risk-assessment-guidelines.
16. USEPA. Pesticide Science and Assessing Pesticide Risks. https://www.epa.gov/pesticide-science-and-assessing-pesticide-risks.
17. USEPA. Predictive Models and Tools for Assessing Chemicals under
the Toxic Substances Control Act (TSCA). https://www.epa.gov/tsca-screening-tools.
18. Office of Management and Budget Final Information Quality
Bulletin for Peer Review. Washington, DC. 2004. https://19january2017snapshot.epa.gov/sites/production/files/2015-01/documents/omb_final_info_quality_bulletin_peer_review_2004_1.pdf.
19. USEPA. Peer Review Handbook. 3rd ed. EPA/100/B-06/002. Science
Policy Council. Washington, DC. 2006. https://www.epa.gov/osa/peer-review-handbook-4th-edition-2015.

VII. Statutory and Executive Order Reviews

    Additional information about these statutes and Executive Orders
can be found at http://www2.epa.gov/laws-regulatios/laws-and-executive-orders.

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

    This action is a significant regulatory action that was submitted
to the Office of Management and Budget (OMB) for review under Executive
Orders 12866 (58 FR 51735, October 4, 1993) and 13563 (76 FR 3821,
January 21, 2011), and any changes made in response to OMB
recommendations are documented in the docket. EPA conducted an analysis
of the potential costs associated with this action. This analysis, can
be found in Unit V. This action is not subject to the requirements of
Executive Order 13771, entitled ``Reducing Regulation and Controlling
Regulatory Costs'' (82 FR 9339, February 3, 2017) because this rule
results in no more than de mimimis costs.

B. Paperwork Reduction Act (PRA)

    The information collection activities associated with this rule
have been submitted to OMB for review and approval under the PRA, 44
U.S.C. 3501 et seq. Specifically, EPA has prepared an ICR to estimate
the potential burden and costs associated with the requirements for
submitting a request for an Agency-conducted risk evaluation on a
particular chemical substance. The ICR, which is available in the
docket, has been assigned the EPA ICR number 2559.01. You can find a
copy of the ICR in the docket for this rule (Ref. [Insert reference
#]), and it is briefly summarized here.
    Respondents/Affected Entities: Manufacturers (including importers).
    Respondent's Obligation to Respond: Optional, i.e., needed only if
they are requesting an EPA-conducted risk evaluation for a particular
chemical substance.
    Estimated Number of Respondents: 5.
    Frequency of Response: On occasion.
    Total Estimated Annual Burden: 419.2 hours. Burden is defined in 5
CFR 1320.3(b).
    Total Estimated Annual Cost: $282,861 for burden hours. There are
no O&M costs.
    An agency may not conduct or sponsor, and a person is not required
to respond to a collection of information unless it displays a
currently valid OMB control number. The OMB control numbers for the
EPA's regulations in 40 CFR are listed in 40 CFR part 9.

C. Regulatory Flexibility Act (RFA)

    EPA certifies under section 605(b) of the RFA, 5 U.S.C. 601 et
seq., that this action will not have a significant economic impact on a
substantial number of small entities. Although this rule primarily
addresses internal EPA procedures and activities associated with
conducting risk evaluations for chemical substances as required by
TSCA, EPA is also including the process and content requirements for a
manufacturer (including importer) to request that EPA conduct a risk
evaluation on particular uses of interest of a chemical substance. EPA
has determined that the process and content requirements proposed will
have minimal impact on an entity, regardless of size, because there is
no mandate for them to make such a request, and the information they
must provide should they decide to make such a request, which involves
basic information about the chemical substance and the manufacturer's
reasons for requesting the EPA-conducted risk evaluation on that
chemical substance, should be readily available to the manufacturer.
Estimated potential burden and costs are presented in the ICR (Ref. 1).
    EPA developed estimates for the number of manufacturers likely to
submit a request for a chemical substance to be considered for a risk
evaluation. EPA has never collected submissions of this nature in the
past, so the actual number of expected submissions is unknown. EPA
estimates five manufacturer-requested submissions may be sent to EPA in
any given year. Based on the average number of manufacturers (and small
businesses) per chemical for the ten chemicals initially identified by
EPA for risk evaluation, EPA estimates an average of 35 manufacturers
will be involved with the five manufacturer-requested submissions for
risk evaluations each year. Of the 35 affected manufacturers, 15 are
estimated to be small businesses. Based on the ten chemicals initially
identified by EPA for risk evaluations, there are an average of seven
manufacturers per chemical. Assuming that submission costs are shared
equally within a consortium of seven manufacturers, the one-time
respondent cost of $56,572 per submission would be $8,082 per
manufacturer.
    Based on revenue data from U.S. Census Statistics of US Business
and an estimated cost of $8,082 per manufacturer, EPA estimated the
proportion of small manufacturer firms that could have a cost impact of
less than 1%; between 1% and 3%; and more than 3% of the average
revenues. The proportion of small business firms which may incur a cost
impact of less than 1% of the average revenues is 76% of the small
firms (approximately 11 of the 15 affected small manufacturers). The
proportion of small business firms which may incur a cost impact
between 1% and 3% of the average revenues is 23% of the small firms
(approximately 3 of the 15 affected small manufactures). The proportion
of small business firms which may incur a cost impact greater than 3%
of the average revenues is 1% of the small firms (approximately 1 of
the 15 small manufacturers).
    The decision to request a risk assessment for a chemical is
voluntary and manufacturers may decide not to make such a request. But
if such a request is made, the burden for the needed paperwork still
does not result in a significant economic impact on a substantial
number of small entities.

D. Unfunded Mandates Reform Act (UMRA)

    This Action does not contain any unfunded mandate as described in
UMRA, 2 U.S.C. 1531-1538, and does not significantly or uniquely affect
small governments. The action imposes no enforceable duty on any state,
local or tribal governments or the private sector.

E. Executive Order 13132: Federalism

    This action does not have federalism implications as specified in
Executive Order 13132 (64 FR 43255, August 10, 1999). It will not have
substantial direct effects on the states, on the relationship between
the national government and the states, or on the distribution of power
and responsibilities among the various levels of government.

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

    This action does not have tribal implications as specified in
Executive Order 13175 (65 FR 67249, November 9, 2000). It will not have
substantial direct effects 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. Thus, Executive Order 13175 does not
apply to this action.

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

    The EPA interprets Executive Order 13045 (62 FR 19885, April 23,
1997) as applying only to those regulatory actions that concern
environmental health or safety risks that the EPA has reason to believe
may disproportionately affect children, per the definition of ``covered
regulatory action'' in section 2-201 of the Executive Order. This
action is not subject to Executive Order 13045 because it does not
concern an environmental health risk or safety risk.

H. Executive Order 13211: Actions Concerning Regulations That
Significantly Affect Energy Supply, Distribution, or Use

    This action is not a ``significant energy action'' as defined in
Executive Order 13211 (66 FR 28355, May 22, 2001), because it is not
likely to have a significant adverse effect on the supply, distribution
or use of energy.

I. National Technology Transfer and Advancement Act (NTTAA)

    This action does not involve any technical standards, and is
therefore not subject to considerations under NTTAA section 12(d), 15
U.S.C. 272 note.

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

    This action does not establish an environmental health or safety
standard, and is therefore not subject to environmental justice
considerations under Executive Order 12898 (59 FR 7629, February 16,
1994). This is a procedural rule that will not affect the level of
protection provided to human health or the environment.

K. Congressional Review Act (CRA)

    This action is subject to the CRA, 5 U.S.C. 801 et seq., and EPA
will submit a rule report to the U.S. Senate, and the U.S. House of
Representatives, and the Comptroller General of the United States. This
action is not a ``major rule'' as defined by 5 U.S.C. 804(2).

List of Subjects in 40 CFR Part 702

    Environmental protection, Chemicals, Chemical substances, Hazardous
substances, Health and safety, Risk evaluation.

    Dated: June 22, 2017.
E. Scott Pruitt,
Administrator.

    Therefore, 40 CFR chapter I, subchapter R, is amended as follows:

PART 702--[AMENDED]

0
1. The authority citation for part 702 is revised to read as follows:

     Authority:  15 U.S.C. 2605 and 2619.

0
2. Add subpart B to read as follows:

Subpart B--Procedures for Chemical Substance Risk Evaluations

Sec.
702.31 General provisions.
702.33 Definitions.
702.35 Chemical substances designated for risk evaluation.
702.37 Submission of manufacturer requests for risk evaluations.
702.39 Interagency collaboration.
702.41 Evaluation requirements.
702.43 Risk Characterization.
702.45 Peer review.
702.47 Unreasonable risk determination.
702.49 Risk evaluation timeframes and actions.
702.51 Publically available information.

Sec.  702.31  General provisions.

    (a) Purpose. This subpart establishes the EPA process for
conducting a risk evaluation to determine whether a chemical substance
presents an unreasonable risk of injury to health or the environment as
required under TSCA section 6(b)(4)(B) (15 U.S.C. 2605(b)(4)(B)).
    (b) Scope. These regulations establish the general procedures, key
definitions, and timelines EPA will use in a risk evaluation conducted
pursuant to TSCA section 6(b) (15 U.S.C. 2605(b)).
    (c) Applicability. The requirements of this part apply to all
chemical substance risk evaluations initiated pursuant to TSCA section
6(b) (15 U.S.C. 2605(b)).
    (d) Enforcement. Submission to EPA of inaccurate, incomplete, or
misleading information pursuant to a risk evaluation conducted pursuant
to 15 U.S.C. 2605(b)(4)(B) is a prohibited act under 15 U.S.C. 2614,
subject to penalties under 15 U.S.C. 2615 and Title 18 of the U.S.
Code.

Sec.  702.33  Definitions.

    All definitions in TSCA apply to this subpart. In addition, the
following definitions apply:
    Act means the Toxic Substances Control Act, as amended (15 U.S.C.
2601 et seq.).
    Aggregate exposure means the combined exposures to an individual
from a single chemical substance across multiple routes and across
multiple pathways.
    Best available science means science that is reliable and unbiased.
Use of best available science involves the use of supporting studies
conducted in accordance with sound and objective science practices,
including, when available, peer reviewed science and supporting studies
and data collected by accepted methods or best available methods (if
the reliability of the method and the nature of the decision justifies
use of the data). Additionally, EPA will consider as applicable:
    (1) The extent to which the scientific information, technical
procedures, measures, methods, protocols, methodologies, or models
employed to generate the information are reasonable for and consistent
with the intended use of the information;
    (2) The extent to which the information is relevant for the
Administrator's use in making a decision about a chemical substance or
mixture;
    (3) The degree of clarity and completeness with which the data,
assumptions, methods, quality assurance, and analyses employed to
generate the information are documented;
    (4) The extent to which the variability and uncertainty in the
information, or in the procedures, measures, methods, protocols,
methodologies, or models, are evaluated and characterized; and
    (5) The extent of independent verification or peer review of the
information or of the procedures, measures, methods, protocols,
methodologies or models.
    Conditions of use means the circumstances, as determined by the
Administrator, under which a chemical substance is intended, known, or
reasonably foreseen to be manufactured, processed, distributed in
commerce, used, or disposed of.
    EPA means the U.S. Environmental Protection Agency.
    Pathways means the mode through which one is exposed to a chemical
substance, including but not limited to: Food, water, soil, and air.
    Potentially exposed or susceptible subpopulation means a group of
individuals within the general population identified by the Agency who,
due to either greater susceptibility or greater exposure, may be at
greater risk than the general population of adverse health effects from
exposure to a chemical substance or mixture, such as infants, children,
pregnant women, workers, or the elderly.
    Reasonably available information means information that EPA
possesses or can reasonably generate, obtain, and synthesize for use in
risk evaluations, considering the deadlines specified in TSCA section
6(b)(4)(G) for completing such evaluation. Information that meets the
terms of the preceding sentence is reasonably available information
whether or not the information is confidential business information,
that is protected from public disclosure under TSCA section 14.
    Routes means the particular manner by which a chemical substance
may contact the body, including absorption via ingestion, inhalation,
or dermally (integument).
    Sentinel exposure means the exposure from a single chemical
substance that represents the plausible upper bound of exposure
relative to all other exposures within a broad category of similar or
related exposures.
    Uncertainty means the imperfect knowledge or lack of precise
knowledge of the real world either for specific values of interest or
in the description of the system.
    Variability means the inherent natural variation, diversity, and
heterogeneity across time and/or space or among individuals within a
population.
    Weight of scientific evidence means a systematic review method,
applied in a manner suited to the nature of the evidence or decision,
that uses a pre-established protocol to comprehensively, objectively,
transparently, and consistently, identify and evaluate each stream of
evidence, including strengths, limitations, and relevance of each study
and to integrate evidence as necessary and appropriate based upon
strengths, limitations, and relevance.

Sec.  702.35  Chemical substances designated for risk evaluation.

    (a) Chemical substances undergoing risk evaluation. A risk
evaluation for a chemical substance designated by the Agency as a High-
Priority Substance pursuant to the prioritization process described in
subpart A, identified under 15 U.S.C. 2605(b)(2)(A), or initiated at
the request of a manufacturer or manufacturers under Sec.  702.37, will
be conducted in accordance with this part, except that risk evaluations
that are initiated prior to the effective date of this rule will be
conducted in accordance with this part to the maximum extent
practicable.
    (b) Percentage requirements. The Agency will ensure that, of the
number of chemical substances that undergo risk evaluation under 15
U.S.C. 2605(b)(4)(C)(i), the number of chemical substances undergoing
risk evaluation under 15 U.S.C. 2605(b)(4)(C)(ii) is not less than 25%,
if sufficient requests that comply with 702.37, and not more than 50%.
    (c) Manufacturer requests for work plan chemical substances.
Manufacturer requests for risk evaluations, described in paragraph (a)
of this section, for chemical substances that are drawn from the 2014
update of the TSCA Work Plan for Chemical Assessments will be granted
at the discretion of the Agency. Such evaluations are not subject to
the percentage requirements in paragraph (b) of this section.

Sec.  702.37  Submission of manufacturer requests for risk evaluations.

    (a) General provision. Any request that EPA conduct a risk
evaluation pursuant to this part must comply with all the procedures
and criteria in this section to be eligible to be granted by EPA.
    (b) Method for submission. One or more manufacturers of a chemical
substance may request that EPA conduct a risk evaluation. All requests
submitted to EPA under this subpart must be submitted via the EPA
Central Data Exchange (CDX) found at http://cdx.epa.gov. 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 A request for risk
evaluations of a category of chemical substances must include an
explanation of why the category is appropriate under 15 U.S.C. 2625(c),
and EPA will grant such request only upon determining that the
requested category is appropriate for risk evaluation.
    (3) The manufacturer must identify the circumstances on which they
are requesting that EPA conduct a risk evaluation and include a
rationale for why these circumstances constitute conditions of use
under Sec.  702.33.
    (4) The request must also include a list of all the existing
information that is relevant to whether the chemical substance, under
the circumstances identified by the manufacturer(s), presents an
unreasonable risk of injury to health or the environment. The list must
be accompanied by an explanation as to why such information is adequate
to permit EPA to complete a risk evaluation addressing the
circumstances identified by the manufacturer(s), The request need not
include copies of the information; citations are sufficient, if the
information is publically available. The request must include or
reference all available information on the health and environmental
hazard(s) of the chemical substance, human and environmental
exposure(s), and exposed population(s), as relevant to the
circumstances identified in the request. At a minimum, this must
include all the following, as relevant to the circumstances identified:
    (i) The chemical substance's hazard and exposure potential;
    (ii) The chemical substance's persistence and bioaccumulation;
    (iii) Potentially exposed or susceptible subpopulations which the
manufacturer(s) believes to be relevant to the EPA risk evaluation;
    (iv) 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);
    (v) The chemical substance's production volume or significant
changes in production volume; and
    (vi) Any other information relevant to the potential risks of the
chemical substance under the circumstances identified in the request.
    (5) The request must include a commitment to provide to EPA any
referenced information upon request.
    (6) Scientific information submitted must be consistent with the
scientific standards in 15 U.S.C. 2625(h).
    (7) 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 manufacturers the chemical
substance identified for risk evaluation.
    (B) All information provided in the notice is complete and accurate
as of the date of the request.
    (C) I have either identified or am submitting all information in my
possession, control, and a description of all other data known to or
reasonably ascertainable by me as required for this request 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.
    (ii) [Reserved]
    (c) Optional elements. A manufacturer may provide 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).
    (d) Confidential business information. (1) Persons submitting a
request under this subpart are subject to EPA confidentiality
regulations at 40 CFR part 2, subpart B.
    (2) In submitting a claim of confidentiality, a person must certify
the accuracy of the following statements concerning all information
claimed as confidential:
    (i) I hereby certify to the best of my knowledge and belief that
all information entered on this form is complete and accurate. I
further certify that, pursuant to 15 U.S.C. 2613(c), for all claims for
confidentiality made with this submission, all information submitted to
substantiate such claims is true and correct, and that it is true and
correct that:
    (A) My company has taken reasonable measures to protect the
confidentiality of the information;
    (B) I have determined that the information is not required to be
disclosed or otherwise made available to the public under any other
Federal law;
    (C) I have a reasonable basis to conclude that disclosure of the
information is likely to cause substantial harm to the competitive
position of my company; and
    (D) I have a reasonable basis to believe that the information is
not readily discoverable through reverse engineering.
    (ii) [Reserved]
    (3) Each claim of confidentiality, other than a claim pertaining to
information described in TSCA section 14(c)(2), must be accompanied by
a substantiation in accordance with 15 U.S.C. 2613.
    (4) Manufacturers must supply a structurally descriptive generic
name where specific chemical identity is claimed as CBI.
    (5) Any knowing and willful misrepresentation, under this section,
is subject to criminal penalty pursuant to 18 U.S.C. 1001.
    (e) EPA process for evaluating manufacturer requests--(1) Review
for completeness. Upon receipt of the request, EPA will verify that the
request is facially complete, i.e., that information has been submitted
that appears to be consistent with the requirements in paragraphs (b)
through (d) of this section. EPA will inform the submitting
manufacturer(s) if EPA has determined that the request is incomplete,
and cannot be processed. Facially complete requests will be processed
as described in this subpart.
    (2) Public notification of receipt of request. Within 15 business
days of receipt of a facially complete submission, EPA will notify the
public of receipt of the manufacturer request. This notification will
include any information submitted by the manufacturer that is not CBI,
including the condition(s) of use for which the evaluation is
requested.
    (3) Conditions of use to be evaluated. EPA will assess whether the
circumstances identified in the request constitute condition of use
under

Sec.  702.33, and whether those conditions of use warrant inclusion
within the scope of a risk evaluation for the chemical substance. EPA
will also assess what, if any, additional conditions of use that
warrant inclusion within the scope of a risk evaluation for the
chemical substance. EPA will conduct these assessments and make
proposed determinations based on the same considerations applied in the
same manner as it would for a risk evaluation for a high-priority
substance.
    (4) Public notice and comment. No later than 60 business days of
receiving a request that EPA has determined to be complete under
paragraph (e)(1) of this section, EPA will submit for publication the
receipt of the request in the Federal Register, open a docket for that
request and provide no less than a 45 calendar day public comment
period. The docket will contain the manufacturer request (excluding
information claimed as CBI) and EPA' proposed additions of conditions
of use as described in paragraph (e)(3) of this section, and the basis
for these proposed additions. During the comment period the public may
submit comments and information relevant to the requested risk
evaluation, in particular, commenters are encouraged to identify any
information not included in the request or the proposed determinations
that the commenters believe would be needed to conduct a risk
evaluation, and to provide any other information relevant to EPA's
proposed determinations of the conditions of use, such as information
on other conditions of use of the chemical than those included in the
request or in EPA's proposed determinations
    (5) Supplementation of original request. (i) At any time prior to
the end of the comment period, the requesting manufacturer(s) may
supplement the original request with any new information it receives.
    (ii) At any point prior to the completion of a risk evaluation
pursuant to this section, manufacturer(s) must supplement the original
request with any information that meets the criteria in 15 U.S.C.
2607(e) and this section, or with any other information that has the
potential to change EPA's risk evaluation with respect to the
conditions of use as requested by the manufacturer. Such information
must be submitted consistent with section 8(e) if the information is
subject to that section or otherwise within 30 calendar days of the
manufacturer's obtaining the information.
    (6) EPA's decision. (i) Within 60 days of the end of the comment
period provided in paragraph (e)(4) of this section, EPA will review
the request along with any additional information received during the
comment period to determine whether the request meets the criteria and
requirements of this section.
    (ii) EPA will grant the request if it determines that all of the
following have been met:
    (A) That the circumstances identified in the request constitute
conditions of use that warrant inclusion in a risk evaluation for the
chemical substance;
    (B) That EPA has all of the information needed to conduct such risk
evaluation on the conditions of use that were the subject of the
request; and
    (C) All other criteria and requirements of this section have been
met.
    (iii) At the end of this 60-day period, EPA will notify the
submitting manufacturer(s) of its decision and include the basis for
granting or denying the request. Bases for a denial, include the
manufacturer has not provided sufficient information to complete the
risk evaluation on the condition(s) of use requested, or that the
circumstances identified in the request either do not constitute
conditions of use, or the conditions of use do not warrant inclusion in
a risk evaluation for the chemical substance. This notification will
also identify any additional conditions of use, as determined by the
Administrator, that will be included in this risk evaluation.
    (iv) Within 30 days of receipt of EPA's notification the
requester(s) may withdraw the request.
    (7) Public notice of decision. EPA will make public EPA's decision
to grant or deny the request at the time that EPA notifies the
manufacturer.
    (8) Compliant request. EPA will initiate a risk evaluation for all
requests for non-TSCA Work Plan Chemicals that meet the criteria in
this subpart, until EPA determines that the number of manufacturer-
requested chemical substances undergoing risk evaluation is equal to
25% of the High-Priority Substances identified in subpart A as
undergoing risk evaluation. Once that level has been reached, EPA will
initiate at least one new manufacturer-requested risk evaluation for
each manufacturer-requested risk evaluation completed so long as there
are sufficient requests that meet the criteria of this subpart, as
needed to ensure that the number of manufacturer-requested risk
evaluations is equal to at least 25% of the High-Priority substances
risk evaluation and not more than 50%.
    (9) Preferences. In conformance with Sec.  702.35(c), in evaluating
requests for TSCA Work Plan Chemicals and requests for non-TSCA Work
Plan chemicals in excess of the 25% threshold in Sec.  702.35(b), EPA
will first give preference to requests for risk evaluations on chemical
substances:
    (i) First, for which the Agency determines that restrictions
imposed by one or more States have the potential to have a significant
impact on interstate commerce, health or the environment; and then
    (ii) Second, based on the order in which the requests are received.
    (10) No preferential treatment. Once granted, EPA will initiate the
risk evaluation and thereafter will conduct the risk evaluation
following the procedures in Sec. Sec.  702.39 through 702.51. EPA will
not expedite or otherwise provide special treatment to a risk
evaluation conducted as a result of a manufacturer's request.
    (11) Fees. Manufacturers must pay fees to support risk evaluations
as specified under 15 U.S.C. 2605(b)(4)(E)(ii).

Sec.  702.39  Interagency collaboration.

    During the risk evaluation process, not to preclude any additional,
prior, or subsequent collaboration, EPA will consult with other
relevant Federal agencies.

Sec.  702.41  Evaluation requirements.

    (a) Considerations. (1) Each risk evaluation will include all of
the following components:
    (i) A Scope, including a Conceptual Model and an Analysis Plan;
    (ii) A Hazard Assessment;
    (iii) An Exposure Assessment;
    (iv) A Risk Characterization; and
    (v) A Risk Determination.
    (2) EPA guidance will be used, as applicable where it represents
the best available science appropriate for the particular risk
evaluation.
    (3) Where appropriate, a risk evaluation will be conducted on a
category of chemical substances. EPA will determine whether to conduct
an evaluation on a category of chemical substances, and the composition
of the category based on the considerations listed in 15 U.S.C.
2625(c).
    (4) EPA will document that it has used the best available science
and weight of scientific evidence approaches in the risk evaluation
process.
    (5) EPA will ensure that all supporting analyses and components of
the risk evaluation are suitable for their intended purpose, and well-
tailored to the problems and decision at hand, in order to inform the
development of a technically sound determination as to whether a
chemical substance presents an unreasonable risk of injury to health or
the environment under the

conditions of use within the scope of the risk evaluation, based on the
weight of the scientific evidence.
    (6) The extent to which EPA will refine its evaluations for one or
more condition of use in any risk evaluation will vary as necessary to
determine whether a chemical substance presents an unreasonable risk of
injury to health or the environment.
    (7) To the extent a determination as to the level of risk presented
by a condition of use can be made, for example, using assumptions,
uncertainty factors, and models or screening methodologies, EPA may
determine that no further information or analysis is needed to complete
its risk evaluation of the condition(s) of use.
    (8) In general, EPA intends to determine whether a chemical
substance does or does not present an unreasonable risk under all of
the conditions of use within the scope of the risk evaluations, and
intends to identify the individual conditions of use or categories of
conditions of use that are responsible for such determinations.
    (9) Within the time frame in Sec.  702.43(d), EPA will complete the
risk evaluation of the chemical substance addressing all of the
conditions of use within the scope of the evaluation. However, EPA may
complete its evaluation of the chemical substance under specific
conditions of use or categories of conditions of use at any point
following the issuance of the final scope document, and issue its
determination as to whether the chemical substance under those
conditions of use does or does not present an unreasonable risk to
health or the environment under those conditions of use. EPA will
follow all of the requirements and procedures in this Subpart when it
conducts its evaluation of the chemical substance under any individual
or specific conditions of use.
    (10) EPA will evaluate chemical substances that are metals or metal
compounds in accordance with 15 U.S.C. 2605(b)(2)(E).
    (b) Information and information sources. (1) EPA will base each
risk evaluation on reasonably available information.
    (2) EPA generally expects to initiate a risk evaluation for a
chemical substance when EPA believes that all or most of the
information necessary to perform the risk evaluation is reasonably
available. EPA expects to use its authorities under the Act, and other
information gathering authorities, when necessary to obtain the
information needed to perform a risk evaluation for a chemical
substance before initiating the risk evaluation for such substance. EPA
will use such authorities on a case-by-case basis during the
performance of a risk evaluation to obtain information as needed to
ensure that EPA has adequate, reasonably available information to
perform the evaluation.
    (3) Among other sources of information, the Agency will consider
information and advice provided by the Science Advisory Committee on
Chemicals established pursuant to 15 U.S.C. 2625.
    (4) In conducting risk evaluations, EPA will utilize reasonably
available information including information, models, and screening
methodologies, as appropriate. The approaches used will be determined
by the quality of the information, the deadlines specified in TSCA
section 6(b)(4)(G) for completing the risk evaluation, and the extent
to which the information reduces uncertainty.
    (5) Where appropriate, to the extent practicable, and
scientifically justified, EPA will require the development of
information generated without the use of new testing on vertebrates in
performing risk evaluation.
    (c) Scope of the risk evaluation. The scope of the risk evaluation
will include all the following:
    (1) The condition(s) of use, as determined by the Administrator,
that the EPA plans to consider in the risk evaluation.
    (2) The potentially exposed populations, including any potentially
exposed or susceptible subpopulations as identified as relevant to the
risk evaluation by the Agency under the conditions of use, that EPA
plans to evaluate; the ecological receptors that EPA plans to evaluate;
and the hazards to health and the environment that EPA plans to
evaluate.
    (3) A description of the reasonably available information and
science approaches EPA plans to use in the risk evaluation.
    (4) A conceptual model:
    (i) The scope documents will include a Conceptual Model that
describes actual or predicted relationships between the chemical
substance, the conditions of use within the scope of the evaluation and
human and environmental receptors.
    (ii) The conceptual model will identify human and ecological health
hazards the EPA plans to evaluate for the exposure scenarios EPA plans
to evaluate.
    (iii) Conceptual model development will consider the life cycle of
the chemical substance, including manufacture, processing, distribution
in commerce, storage, use, and disposal, relevant to the conditions of
use within the scope of the evaluation
    (5) An analysis plan:
    (i) The scope documents will include an analysis plan that
identifies the approaches, methods, and/or metrics that EPA plans to
use to assess exposures, effects, and risk, including associated
uncertainty and variability for each risk evaluation. The analysis plan
will also identify the strategy for using information, accepted science
policies, models, and screening methodologies.
    (ii) Hypotheses about the relationships identified in the
conceptual model will be described. The relative strengths of
alternative hypotheses if any will be evaluated to determine the
appropriate risk assessment approaches.
    (6) The Agency's plan for peer review.
    (7) Developing the scope.
    (i) Draft scope. For each risk evaluation to be conducted EPA will
publish a document in the Federal Register that specifies the draft
scope of the risk evaluation the Agency plans to conduct. The document
will address the elements in paragraphs (c)(1) through (6) of this
section.
    (ii) Timeframes. EPA generally expects to publish the draft scope
no later than 3 months from the initiation of the risk evaluation
process for the chemical substance.
    (iii) Public comments. EPA will allow a public comment period of no
less than 45 calendar days during which interested persons may submit
comment on EPA's draft risk evaluation scope. EPA will open a docket to
facilitate receipt of public comments.
    (8) Final scope:
    (i) The Agency will, no later than 6 months after the initiation of
a risk evaluation, publish a document in the Federal Register that
specifies the final scope of the risk evaluation the Agency plans to
conduct. The document shall address the elements in paragraphs (c)(1)
through (6) of this section.
    (ii) For a chemical substance designated as a High-Priority
Substance under subpart A of this part, EPA will not publish the final
scope of the risk evaluation until at least 12 months have elapsed from
the initiation of the prioritization process for the chemical
substance.
    (d) Hazard assessment. (1) The hazard information relevant to the
chemical substance will be evaluated using hazards identified in the
final scope document published pursuant to paragraph (c)(8) of this
section, for the identified exposure scenarios, including any
identified potentially exposed or susceptible subpopulation(s).

    (2) The hazard assessment process will identify the types of
hazards to health or the environment posed by the chemical substance
under the condition(s) of use within the scope of the risk evaluation.
Hazard information related to potential health and environmental
hazards of the chemical substance will be reviewed in a manner
consistent with best available science and weight of scientific
evidence as defined in Sec.  702.33 and all assessment methods will be
documented. This process includes the identification, evaluation, and
synthesis of information to describe the potential health and
environmental hazards of the chemical substance.
    (3) Relevant potential human and environmental hazards will be
evaluated.
    (4) The relationship between the dose of the chemical substance and
the occurrence of health and environmental effects or outcomes will be
evaluated.
    (5) Studies evaluated may include, but would not be limited to:
Human epidemiological studies, in vivo and/or in vitro laboratory
studies, biomonitoring studies, mechanistic and/or kinetic studies in a
variety of test systems, including but not limited to toxicokinetics
and toxicodynamics, computational toxicology such as high-throughput
assays, genomic response assays, data from structure-activity
relationships, and ecological field data.
    (6) Hazard identification will include an evaluation of the
strengths, limitations, and uncertainties associated with the
reasonably available information.
    (7) The human health hazard assessment will consider all
potentially exposed and susceptible subpopulation(s) determined to be
relevant, as identified in the final scope document published pursuant
to paragraph (c)(8) of this section.
    (8) The environmental health hazard assessment will consider the
relationship between the chemical substance and the occurrence of an
ecological hazard elicited.
    (e) Exposure assessment. (1) Where relevant, the likely duration,
intensity, frequency, and number of exposures under the conditions of
use will be considered.
    (2) Chemical-specific factors including, but not limited to:
Physical- chemical properties and environmental fate and transport
parameters will be examined.
    (3) Exposure information related to potential human health or
ecological hazards of the chemical substance will be reviewed in a
manner consistent with the description of best available science and
weight of scientific evidence in Sec.  702.33 and all methods will be
documented.
    (4) The human health exposure assessment will consider all
potentially exposed and susceptible subpopulation(s) determined to be
relevant, as identified in the final scope document published pursuant
to paragraph (c)(8) of this section.
    (5) Environmental health exposure assessment:
    (i) The environmental health exposure assessment will characterize
and evaluate the interaction of the chemical substance with the
ecological receptors identified in the final scope document published
pursuant to paragraph (c)(8) of this section.
    (ii) Exposures considered will include populations and communities,
depending on the chemical substance and the ecological characteristic
involved.

Sec.  702.43  Risk Characterization.

    (a) Risk Characterization considerations. EPA will:
    (1) Integrate the hazard and exposure assessments into quantitative
and/or qualitative estimates of risk for the identified populations
(including any potentially exposed or susceptible subpopulation(s))
identified in the final scope document published pursuant to Sec.
702.41(c)(8) and ecological characteristics for the conditions of use
within the scope of the risk evaluation;
    (2) Describe whether aggregate or sentinel exposures under the
conditions of use were considered and the basis for their
consideration;
    (3) Not consider costs or other nonrisk factors;
    (4) Take into account, where relevant, the likely duration,
intensity, frequency, and number of exposures under the condition(s) of
use of the chemical substance; and
    (5) Describe the weight of the scientific evidence for the
identified hazards and exposures.
    (b) Risk Characterization summary. The Risk Characterization will
summarize, as applicable, the considerations addressed throughout the
evaluation components, in carrying out the obligations under 15 U.S.C.
2625(h). This summary will include, as appropriate, a discussion of:
    (1) Considerations regarding uncertainty and variability.
Information about uncertainty and variability in each step of the risk
evaluation (e.g., use of default assumptions, scenarios, choice of
models, and information used for quantitative analysis) will be
integrated into an overall characterization and/or analysis of the
impact of the uncertainty and variability on estimated risks. EPA may
describe the uncertainty using a qualitative assessment of the overall
strength and limitations of the data used in the assessment.
    (2) Considerations of data quality. A discussion of data quality
(e.g., reliability, relevance, and whether methods employed to generate
the information are reasonable for and consistent with the intended use
of the information), as well as assumptions used, will be included to
the extent necessary. EPA also expects to include a discussion of the
extent of independent verification or peer review of the information or
of the procedures, measures, methods, protocols, methodologies, or
models used in the risk evaluation.
    (3) Considerations of alternative interpretations. If appropriate
and relevant, where alternative interpretations are plausible, a
discussion of alternative interpretations of the data and analyses will
be included.
    (4) Considerations for environmental risk evaluations. For
environmental risk evaluations, it may be necessary to discuss the
nature and magnitude of the effects, the spatial and temporal patterns
of the effects, implications at the individual, species, population,
and community level, and the likelihood of recovery subsequent to
exposure to the chemical substance.

Sec.  702.45  Peer review.

    The EPA Peer Review Handbook (2015), the Office of Management and
Budget Final Information Quality Bulletin for Peer Review (OMB
Bulletin), and other available, relevant and applicable methods
consistent with 15 U.S.C. 2625, will serve as the guidance for peer
review activities. Peer review will be conducted on the risk
evaluations for the chemical substances identified pursuant to 15
U.S.C. 2605(b)(4)(A).

Sec.  702.47  Unreasonable risk determination.

    As part of the risk evaluation, EPA will determine whether the
chemical substance presents an unreasonable risk of injury to health or
the environment under each condition of uses within the scope of the
risk evaluation, either in a single decision document or in multiple
decision documents.

Sec.  702.49  Risk evaluation timeframes and actions.

    (a) Draft risk evaluation timeframe. EPA will publish a draft risk
evaluation in the Federal Register, open a docket to facilitate receipt
of public comment,

and provide no less than a 60-day comment period, during which time the
public may submit comment on EPA's draft risk evaluation.
    (b) Final risk evaluation. (1) EPA will complete a risk evaluation
for the chemical substance under the conditions of use within the scope
of the risk evaluation as soon as practicable, but not later than 3
years after the date on which the Agency initiates the risk evaluation.
    (2) The Agency may extend the deadline for a risk evaluation for
not more than 6 months. The total time elapsed between initiation of
the risk evaluation and completion of the risk evaluation may not
exceed 3 and one half years.
    (3) EPA will publish the final risk evaluation in the Federal
Register.
    (c) Final determination of unreasonable risk. Upon determination by
the EPA that a chemical substance under one or more of the conditions
of use within the scope of the risk evaluation presents an unreasonable
risk of injury to health or the environment as described in Sec.
702.47, the Agency will initiate action as required pursuant to 15
U.S.C. 2605(a).
    (d) Final determination of no unreasonable risk. A determination by
EPA that the chemical substance, under one or more of the conditions of
use within the scope of the risk evaluation, does not present an
unreasonable risk of injury to health or the environment will be issued
by order and considered to be a final Agency action, effective on the
date of issuance of the order.

Sec.  702.51  Publically available information.

    For each risk evaluation, EPA will maintain a public docket at
http://www.regulations.gov to provide public access to the following
information, as applicable for that risk evaluation:
    (a) The draft scope, final scope, draft risk evaluation, and final
risk evaluation;
    (b) All notices, determinations, findings, consent agreements, and
orders;
    (c) Any information required to be provided to the Agency under 15
U.S.C. 2603;
    (d) A nontechnical summary of the risk evaluation;
    (e) A list of the studies, with the results of the studies,
considered in carrying out each risk evaluation;
    (f) The final peer review report, including the response to peer
review and public comments received during peer review; and
    (g) Response to public comments received on the draft scope and the
draft risk evaluation.

[FR Doc. 2017-14337 Filed 7-19-17; 8:45 am]
 BILLING CODE 6560-50-P


[Federal Register: July 30, 2009 (Volume 74, Number 145)]
[Notices]
[Page 38065]
[DOCID:fr30jy09-102]

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SECURITIES AND EXCHANGE COMMISSION

Proposed Collection; Comment Request

Upon Written Request, Copies Available From: Securities and Exchange
Commission, Office of Investor Education and Advocacy, Washington, DC
20549-0213.

Extension:
    Rule 30e-1; SEC File No. 270-21; OMB Control No. 3235-0025.

    Notice is hereby given that, pursuant to the Paperwork Reduction
Act of 1995 (44 U.S.C. 3501 et seq.), the Securities and Exchange
Commission (the ``Commission'') is soliciting comments on the
collection of information summarized below. The Commission plans to
submit this existing collection of information to the Office of
Management and Budget for extension and approval.
    The title for the collection of information is: ``Rule 30e-1 (CFR
270.30e-1) under the Investment Company Act of 1940, Reports to
Stockholders of Management Companies.'' Section 30(e) (15 U.S.C. 80a-
29(e)) of the Investment Company Act of 1940 (``Investment Company
Act'') (15 U.S.C. 80a-1 et seq.) requires a registered investment
company (``fund'') to transmit to its shareholders, at least semi-
annually, reports containing information and financial statements as
the Commission may prescribe. Among other requirements, Rule 30e-1 (17
CFR 270.30e-1) under the Investment Company Act directs funds to
include in the shareholder reports the information that is required by
the fund's registration statement form under the Investment Company
Act. Failure to require the collection of this information would
seriously impede the amount of current information available to
shareholders and the public about funds and would prevent the
Commission from implementing the regulatory program required by
statute. The estimated annual number of respondents providing
shareholder reports under Rule 30e-1 is approximately 2800. The
proposed frequency of response is semi-annual. The estimate of the
total annual reporting burden of the collection of information is
approximately 145.8 hours per shareholder report and the total
estimated annual burden for the industry is 816,480 hours (145.8 hours
per report x 2 reports x 2,800 funds). Providing the information
required by Rule 30e-1 is mandatory. Responses will not be kept
confidential. Estimates of the burden hours are made solely for the
purposes of the Paperwork Reduction Act, and are not derived from a
comprehensive or even a representative survey or study of the costs of
SEC rules and forms.
    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 control number.
    Written comments are invited on: (a) Whether the proposed
collection of information is necessary for the proper performance of
the functions of the agency, including whether the information will
have practical utility; (b) the accuracy of the agency's estimate of
the burden of the collection of information; (c) ways to enhance the
quality, utility, and clarity of the information collected; and (d)
ways to minimize the burden of the collection of information on
respondents, including through the use of automated collection
techniques or other forms of information technology. Consideration will
be given to comments and suggestions submitted in writing within 60
days of this publication.
    Please direct your written comments to Charles Boucher, Director/
CIO, Securities and Exchange Commission, C/O Shirley Martinson, 6432
General Green Way, Alexandria, VA 22312; or send an e-mail to: PRA_
<EMAIL_ADDRESS>
    Dated: July 24, 2009.
Florence E. Harmon,
Deputy Secretary.
[FR Doc. E9-18172 Filed 7-29-09; 8:45 am]

BILLING CODE 8010-01-P


[Federal Register Volume 78, Number 42 (Monday, March 4, 2013)]
[Rules and Regulations]
[Pages 14015-14017]
[FR Doc No: 2013-04897]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 890

[Docket No. FDA-2011-P-0804]

Medical Devices; Exemption From Premarket Notification; Class II
Devices; Powered Patient Transport

AGENCY: Food and Drug Administration, HHS.

ACTION: Final order.

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SUMMARY: The Food and Drug Administration (FDA) is publishing an order
granting a petition requesting exemption from premarket notification
requirements for powered patient transport devices commonly known as
stairway chair lifts. These devices are used to assist in the transfer
of a person with a mobility impairment caused by injury or other
disease up and down flights of stairs. This order exempts stairway
chair lifts, class II devices, from premarket notification and
establishes conditions for exemption for this device that will provide
a reasonable assurance of the safety and effectiveness of the device
without submission of a premarket notification (510(k)). This exemption
from 510(k), subject to these conditions, is immediately in effect for
stairway chair lifts. All other devices classified under FDA's powered
patient transport regulations, including attendant-operated portable
stair-climbing chairs (which are different from wheelchairs) continue
to require submission of 510(k)s. FDA is publishing this order in
accordance with the section of the Food, Drug, and Cosmetic Act (the
FD&C Act) permitting the exemption of a device from the requirement to
submit a 510(k).

DATES: This order is effective March 4, 2013.

FOR FURTHER INFORMATION CONTACT: Brian Pullin, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, rm. 1554, Silver Spring, MD 20993,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Statutory Background

    Section 510(k) of the FD&C Act (21 U.S.C. 360(k)) and its
implementing regulations (21 CFR part 807) require persons who propose
to begin the introduction or delivery for introduction into interstate
commerce for commercial distribution of a device intended for human use
to submit a 510(k) to FDA. The device may not be marketed until

FDA finds it ``substantially equivalent'' within the meaning of section
513(i) of the FD&C Act (21 U.S.C. 360c(i)) to a legally marketed device
that does not require premarket approval.
    On November 21, 1997, the President signed into law the Food and
Drug Administration Modernization Act of 1997 (FDAMA) (Pub. L. 105-
115), section 206 of which added section 510(m) to the FD&C Act.
Section 510(m)(1) of the FD&C Act requires FDA, within 60 days after
enactment of FDAMA, to publish in the Federal Register a list of each
type of class II device that does not require a report under section
510(k) of the FD&C Act to provide reasonable assurance of safety and
effectiveness. Section 510(m) of the FD&C Act further provides that a
510(k) will no longer be required for these devices upon the date of
publication of the list in the Federal Register. FDA published that
list in the Federal Register of January 21, 1998 (63 FR 3142).
    Section 510(m)(2) of the FD&C Act provides that FDA may exempt a
device from premarket notification requirements on its own initiative,
or upon petition of an interested person, if FDA determines that a
510(k) is not necessary to provide reasonable assurance of the safety
and effectiveness of the device. This section requires FDA to publish
in the Federal Register a notice of intent to exempt a device, or of
the petition, and to provide a 30-day comment period. FDA must publish
in the Federal Register its final determination regarding the exemption
of the device that was the subject of the notice. If FDA fails to
respond to a petition under this section within 180 days of receiving
it, the petition shall be deemed granted.

II. Criteria for Exemption

    There are a number of factors FDA may consider to determine whether
a 510(k) is necessary to provide reasonable assurance of the safety and
effectiveness of a class II device. These factors are discussed in the
guidance that the Agency issued on February 19, 1998, entitled
``Procedures for Class II Device Exemptions From Premarket
Notification, Guidance for Industry and CDRH Staff'' (Class II 510(k)
Exemption Guidance). That guidance can be obtained through the Internet
on the Center for Devices and Radiological Health home page at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080198.htm or by sending an email request to
<EMAIL_ADDRESS>to receive an electronic copy of the document or
send a fax request to<PHONE_NUMBER> to receive a hard copy. Please use
the document number 159 to identify the guidance you are requesting.

III. Petition

    On November 7, 2011, FDA received a petition requesting an
exemption from premarket notification for powered patient transport
devices commonly known as stairlifts. (See Docket No. FDA-2011-P-0804.)
These devices are currently classified under Sec.  890.5150 (21 CFR
890.5150), Powered patient transport. On May 3, 2012, FDA responded to
the petition with a letter explaining that the information provided in
the petition was insufficient for the Agency to assess whether the
risks posed by this type of device could be sufficiently mitigated in
the absence of premarket notification requirements. To address the
Agency's concerns, the petitioner submitted additional information
regarding standards that could be relied upon to mitigate the device
risks, which the Agency received on June 19, 2012. This restarted the
180-day clock under section 510(m)(2) of the FD&C Act. (See Class II
510(k) Exemption Guidance, p. 3.)
    In the Federal Register of June 1, 2012 (77 FR 32642), FDA
published a notice announcing that this petition had been received and
provided opportunity for interested persons to submit comments on the
petition by July 2, 2012. FDA received one comment supporting an
exemption from premarket notification for this type of device. The
comment stated that these devices have been produced for many years and
have a very good safety record. It noted that all of these products
already need to comply with the FDA-recognized American Society of
Mechanical Engineers (ASME) standard ``ASME A18.1 Safety Standard for
Platform Lifts and Stairway Chairlifts'' (ASME A18.1), which provides
that these products are to be built and certified to the provisions of
the National Electric Code and the Canadian Standards Association
(CSA)/ASME standard ``CSA B44.1/ASME A17.5 Elevator and Escalator
Electrical Equipment'' for elevator and escalator equipment.
    FDA has assessed the need for 510(k) clearance for this type of
device against the criteria laid out in the Class II 510(k) Exemption
Guidance and in 63 FR 3142, and agrees they weigh in favor of 510(k)
exemption, as long as certain conditions are met. FDA agrees that the
risks posed by the device and the characteristics of the device
necessary for its safe and effective performance are well established.
FDA believes that changes in the device that could affect safety and
effectiveness will be readily detectable by certain types of routine
analysis and nonclinical testing, such as those detailed in certain
consensus standards. Therefore, after reviewing the petition, the
additional information received on June 19, 2012, and the comment on
the petition, FDA has determined that premarket notification is not
necessary to assure the safety and effectiveness of stairway chair
lifts, as long as the conditions for 510(k) exemption listed in this
document are met. FDA responded to the petition by letter dated
December 3, 2012, to inform the petitioner of this decision within the
180-day timeframe under section 510(m)(2) of the FD&C Act.
    For clarity, this order: (1) Defines a subset of powered patient
transport devices classified under Sec.  890.5150 identified as
``powered patient stairway chair lifts,'' and (2) exempts this subset
of devices from premarket notification requirements provided certain
conditions are met, which will be codified in this classification
regulation. This order does not affect other devices classified under
Sec.  890.5150, such as attendant-operated portable stair-climbing
chairs (which are different from wheelchairs), which remain subject to
premarket notification requirements, and does not change the class of
any of the devices classified under this regulation, which all remain
in class II. These devices will remain subject to current good
manufacturing practices requirements and other general controls under
the statute.

IV. Conditions for Exemption

    This final order provides conditions for exemption from premarket
notification on appropriate testing and labeling of the device. The
following conditions must be met for the device to be 510(k)-exempt:
(1) Appropriate analysis and nonclinical testing (such as that outlined
in the currently FDA-recognized edition of ASME A18.1 ``Safety Standard
for Platform Lifts and Stairway Chair Lifts'') must demonstrate that
the safety controls are adequate to prevent a free fall of the chair in
the event of a device failure; (2) appropriate analysis and nonclinical
testing must demonstrate the ability of the device, including armrests,
to withstand the rated load with an appropriate factor of safety; (3)
appropriate restraints must be provided to prevent the user from
falling from the device (such as that outlined in the currently FDA-
recognized edition of ASME A18.1 ``Safety Standard for Platform Lifts
and Stairway Chair Lifts''); (4) appropriate analysis and nonclinical
testing (such as that outlined in the currently FDA-

recognized edition of AAMI/ANSI/IEC 60601-1-2, ``Medical Electrical
Equipment--Part 1-2: General Requirements for Safety--Collateral
Standard: Electromagnetic Compatibility--Requirements and Tests,'' and
ASME A18.1 ``Safety Standard for Platform Lifts and Stairway Chair
Lifts'') must validate electromagnetic compatibility and electrical
safety; and (5) appropriate analysis and nonclinical testing must
demonstrate the resistance of the device upholstery to ignition.
    Firms are now exempt from 510(k) requirements for stairway chair
lifts as long as they meet these conditions of exemption. Firms must
comply with the particular mitigation measures set forth in the
conditions for exemption or submit and receive clearance for a 510(k)
prior to marketing.

V. Environmental Impact

    The Agency has determined under 21 CFR 25.30(h) that this action is
of a type that does not individually or cumulatively have a significant
effect on the human environment. Therefore, neither an environmental
assessment nor an environmental impact statement is required.

VI. Paperwork Reduction Act of 1995

    This final order contains no collection of information. Therefore,
clearance by the Office of Management and Budget under the Paperwork
Reduction Act of 1995 is not required.

List of Subjects in 21 CFR Part 890

    Medical devices, Physical medicine devices.

    Therefore, under the Federal Food, Drug, and Cosmetic Act and under
authority delegated to the Commissioner of Food and Drugs, 21 CFR part
890 is amended as follows:

PART 890--PHYSICAL MEDICINE DEVICES

0
1. The authority citation for 21 CFR part 890 continues to read as
follows:

    Authority:  21 U.S.C. 351, 360, 360c, 360e, 360j, 371.

0
2. Section 890.5150 is revised to read as follows:

Sec.  890.5150  Powered patient transport.

    (a) Powered patient stairway chair lifts--(1) Identification. A
powered patient stairway chair lift is a motorized lift equipped with a
seat and permanently mounted in one location that is intended for use
in mitigating mobility impairment caused by injury or other disease by
moving a person up and down a stairway.
    (2) Classification. Class II. The stairway chair lift is exempt
from premarket notification procedures in subpart E of part 807 of this
chapter, subject to Sec.  890.9 and the following conditions for
exemption:
    (i) Appropriate analysis and nonclinical testing (such as that
outlined in the currently FDA-recognized edition of American Society of
Mechanical Engineers (ASME) A18.1 ``Safety Standard for Platform Lifts
and Stairway Chair Lifts'') must demonstrate that the safety controls
are adequate to prevent a free fall of the chair in the event of a
device failure;
    (ii) Appropriate analysis and nonclinical testing must demonstrate
the ability of the device, including armrests, to withstand the rated
load with an appropriate factor of safety;
    (iii) Appropriate restraints must be provided to prevent the user
from falling from the device (such as that outlined in the currently
FDA-recognized edition of ASME A18.1 ``Safety Standard for Platform
Lifts and Stairway Chair Lifts'');
    (iv) Appropriate analysis and nonclinical testing (such as that
outlined in the currently FDA-recognized editions of AAMI/ANSI/IEC
60601-1-2, ``Medical Electrical Equipment--Part 1-2: General
Requirements for Safety--Collateral Standard: Electromagnetic
Compatibility--Requirements and Tests,'' and ASME A18.1 ``Safety
Standard for Platform Lifts and Stairway Chair Lifts'') must validate
electromagnetic compatibility and electrical safety; and
    (v) Appropriate analysis and nonclinical testing must demonstrate
the resistance of the device upholstery to ignition.
    (b) All other powered patient transport--(1) Identification. A
powered patient transport is a motorized device intended for use in
mitigating mobility impairment caused by injury or other disease by
moving a person from one location or level to another, such as up and
down flights of stairs (e.g., attendant-operated portable stair-
climbing chairs). This generic type of device does not include
motorized three-wheeled vehicles or wheelchairs.
    (2) Classification. Class II.

    Dated: February 27, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-04897 Filed 3-1-13; 8:45 am]
BILLING CODE 4160-01-P


[Federal Register Volume 86, Number 186 (Wednesday, September 29, 2021)]
[Notices]
[Page 53955]
[FR Doc No: 2021-21152]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. ER21-2912-000]

Drew Solar-CA, LLC; Supplemental Notice That Initial Market-Based
Rate Filing Includes Request for Blanket Section 204 Authorization

    This is a supplemental notice in the above-referenced proceeding of
Drew Solar-CA, LLC's application for market-based rate authority, with
an accompanying rate tariff, noting that such application includes a
request for blanket authorization, under 18 CFR part 34, of future
issuances of securities and assumptions of liability.
    Any person desiring to intervene or to protest should file with the
Federal Energy Regulatory Commission, 888 First Street NE, Washington,
DC 20426, in accordance with Rules 211 and 214 of the Commission's
Rules of Practice and Procedure (18 CFR 385.211 and 385.214). Anyone
filing a motion to intervene or protest must serve a copy of that
document on the Applicant.
    Notice is hereby given that the deadline for filing protests with
regard to the applicant's request for blanket authorization, under 18
CFR part 34, of future issuances of securities and assumptions of
liability, is October 13, 2021.
    The Commission encourages electronic submission of protests and
interventions in lieu of paper, using the FERC Online links at http://www.ferc.gov. To facilitate electronic service, persons with internet
access who will eFile a document and/or be listed as a contact for an
intervenor must create and validate an eRegistration account using the
eRegistration link. Select the eFiling link to log on and submit the
intervention or protests.
    Persons unable to file electronically may mail similar pleadings to
the Federal Energy Regulatory Commission, 888 First Street NE,
Washington, DC 20426. Hand delivered submissions in docketed
proceedings should be delivered to Health and Human Services, 12225
Wilkins Avenue, Rockville, Maryland 20852.
    In addition to publishing the full text of this document in the
Federal Register, the Commission provides all interested persons an
opportunity to view and/or print the contents of this document via the
internet through the Commission's Home Page (http://www.ferc.gov) using
the ``eLibrary'' link. Enter the docket number excluding the last three
digits in the docket number field to access the document. At this time,
the Commission has suspended access to the Commission's Public
Reference Room, due to the proclamation declaring a National Emergency
concerning the Novel Coronavirus Disease (COVID-19), issued by the
President on March 13, 2020. For assistance, contact the Federal Energy
Regulatory Commission at<EMAIL_ADDRESS>or call toll-free,
(886) 208-3676 or TYY,<PHONE_NUMBER>.

    Dated: September 23, 2021.
Kimberly D. Bose,
Secretary.
[FR Doc. 2021-21152 Filed 9-28-21; 8:45 am]
BILLING CODE 6717-01-P