[Federal Register Volume 77, Number 24 (Monday, February 6, 2012)]
[Rules and Regulations]
[Pages 5696-5699]
[FR Doc No: 2012-2558]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 201, 312, 314, 601, 610, 801, 807, 809, 812, and 814

[Docket No. FDA-2006-N-0364]

Exceptions or Alternatives to Labeling Requirements for Products
Held by the Strategic National Stockpile

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule.

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SUMMARY: The Food and Drug Administration (FDA) is adopting as a final
rule, without change, the interim final rule that issued regulations
permitting FDA Center Directors to grant exceptions or alternatives to
certain regulatory labeling requirements applicable to human drugs,
biological products, or medical devices that are or will be included in
the Strategic National Stockpile (SNS). FDA is taking this action to
complete the rulemaking initiated with the interim final rule.

DATES: This rule is effective February 6, 2012.

FOR FURTHER INFORMATION CONTACT:
    For information concerning biological products:

Melissa Reisman, Center for Biologics Evaluation and Research (HFM-17),
Food and Drug Administration, 1401 Rockville Pike, suite 200N,
Rockville, MD 20852-1448,<PHONE_NUMBER>.

    For information concerning drug products:

Brad G. Leissa, Center for Drug Evaluation and Research, Food and Drug
Administration, 10001 New Hampshire Ave., Hillandale Building, rm.
2170, Silver Spring, MD 20993,<PHONE_NUMBER>.

    For information concerning medical devices:

Larry Spears, Center for Devices and Radiological Health, Food and Drug
Administration, 10903 New Hampshire Ave., Bldg. 66, rm. 3412, Silver
Spring, MD 20993,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    In the Federal Register of December 28, 2007 (72 FR 73589), FDA
issued an interim final rule entitled ``Exceptions or Alternatives to
Labeling Requirements for Products Held by the Strategic National
Stockpile'' (hereinafter referred to as the interim final rule).\1\
This rule became effective upon the date of publication in the Federal
Register.
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    \1\ In the Federal Register of November 18, 2008 (73 FR 68332),
FDA issued a technical amendment to reincorporate a regulation that
was inadvertently revised by the interim final rule.
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    We issued the interim final rule to facilitate the safety,
effectiveness, and availability of appropriate medical countermeasures
stored in the SNS in the event of a public health emergency. We also
recognized that it may be appropriate for certain human drugs,
biological products, or medical devices (hereinafter referred to
collectively as medical products) that are or will be held in the SNS
to be labeled in a manner that would not comply with certain FDA
labeling requirements. However, noncompliance with these labeling
requirements could render such products misbranded under section 502 of
the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C.
352). Under this rule, the appropriate FDA Center Director may grant
exceptions or alternatives to certain regulatory labeling requirements
applicable to medical products that are or will be included in the SNS
if he or she determines that compliance with the labeling requirements
could adversely affect the safety, effectiveness, or availability of
specified lots, batches, or other units of medical products that are or
will be included in the SNS. An exception or alternative granted under
this rule may include conditions or safeguards deemed appropriate by
the FDA Center Director to ensure that the labeling for such products
includes information necessary for the safe and effective use of the
product given the product's anticipated circumstances of use.
    For example, this rule applies to certain medical products that
enter the SNS as investigational products in addition to medical
products in the SNS that are approved, licensed, or cleared for
marketing.\2\ Labels on investigational products ordinarily would not
contain all elements required on licensed, approved, or cleared product
labels. Certain information, such as expiration dates, warnings for
users, license numbers of manufacturers and other information, may not
be available or finalized for an investigational product, and thus
could not be included on a container label if the investigational
product was added to the SNS. Prior to the implementation of this rule,
when investigational products were ultimately approved for marketing,
the products would have been returned to the manufacturer or sent to
relabelers for relabeling, a potentially time-consuming, costly, and
labor-intensive process. Further, requiring relabeling of such
investigational products after approval, licensure or clearance could
adversely affect the safety, effectiveness, or availability of the
products. This rule allows the appropriate FDA Center Director to grant
an exception or alternative to the relevant labeling requirements to
enable the immediate use of a product in the event of a public health
emergency.
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    \2\ As noted in the preamble to the interim final rule, medical
products stockpiled in the SNS may also include products that will
ultimately be used in an emergency under section 564 of the FD&C Act
(21 U.S.C. 360bbb-3).
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    For these reasons, as explained in the interim final rule and the
following section of this document, this rule allows FDA Center
Directors to grant exceptions or alternatives to certain labeling
requirements not explicitly required by statute for medical products
that are or will be included in the SNS.

II. Comments on the Interim Final Rule and FDA Responses

    We received 7 comments on the proposed rule. These comments were
received from hospitals, biologics manufacturers, law firms, other
government agencies, and other interested persons. To make it easier to
identify comments and our responses, the word ``Comment,'' in
parentheses, will appear before the comment's description, and the word
``Response,'' in parentheses, will appear before our response. We have
also numbered each comment to help distinguish between different
comments. The number assigned to each comment is purely for
organizational purposes and does not signify the comment's value or
importance or the order in which it was received. Certain comments were
grouped together because the subject matter of the comments was
similar.
    (Comment 1) One comment applauded the efforts put forth by the
Agency to provide industry with the opportunity for exceptions or
alternatives to FDA labeling requirements for products held by the SNS.
The comment also recognized the importance of facilitating rapid access
to large quantities of medical products in the event of an act of
terrorism or natural disaster. Another comment expressed general
agreement with the interim final rule.
    (Response) We appreciate these comments in support of the rule.
Congress mandated the development of a SNS to provide for the emergency

health security of the United States in the event of a bioterrorist
attack or other public health emergency (section 319F-2(a) of the
Public Health Service Act (the PHS Act) (42 U.S.C. 247d-6(b))). By
providing a legal mechanism for addressing certain labeling issues
associated with medical products in the SNS without compromising their
safety, effectiveness, or availability for use in an emergency, this
rule is designed to help enable the rapid deployment of medical
countermeasures stored in the SNS in the event of such an emergency.
    (Comment 2) A number of comments responded to FDA's solicitation
for comments as to whether the scope of the rule should be amended to
include medical products in other Federal, State, and local stockpiles.
One comment suggested that FDA expand the rule to include medical
products stored in hospitals. Another comment suggested that the
interim final rule should be extended to medical products stored in the
Department of Defense stockpiles. Yet another comment requested that
the scope of the rule not be extended to medical products in other
Federal, State, or local stockpiles because extending the scope of the
rule would most likely result in manufacturers seeing a high influx of
requests for exceptions or alternatives to labeling requirements under
the rule. Finally, a comment expressed general concern that the interim
final rule is flawed and therefore should not be extended to other
stockpiles.
    (Response) We appreciate the comments received in response to our
solicitation. We have considered the issue, including the points raised
in these comments, and have decided not to extend the rule to other
Federal, State, and local stockpiles. With respect to the comment that
the scope of the rule should be extended to medications stored in
hospitals, we note that the SNS was created by statute to maintain
medical products under centralized control. Centralized control of the
stockpile assures that appropriate products are selected for inclusion
in the SNS and that they are then stored under appropriate conditions.
Centralized control also provides for efficient distribution in the
event of a public health emergency.
    In response to the comment expressing concern that extending the
rule to include additional medical products in other Federal, State, or
local stockpiles would cause a high influx of requests for exceptions
or alternatives to the labeling requirements specified in the rule, we
recognize that extending the rule to other stockpiles may result in a
high influx of requests and further note our concern that such requests
would relate to products outside the control of SNS oversight. We
reiterate that medical products are stockpiled in the SNS under
centralized control to provide for efficient distribution in the event
of a bioterrorist attack or other public health emergency, and this
centralized control helps ensure that adequate procedures are followed
for inventory management and accounting, and for the physical security
of the stockpile. Accordingly, at this time, we decline to expand the
scope of the final rule to apply to medical products in other Federal,
State, and local stockpiles. Additionally, we note our disagreement
with the comment that the interim final rule is generally flawed. As
mandated by Congress, the SNS was created to provide for the emergency
health security of the United States in the event of a public health
emergency such as a bioterrorist attack. The interim final rule is
necessary to give FDA Center Directors the ability to grant exceptions
or alternatives to certain regulatory labeling requirements that could
adversely affect the safety, effectiveness, or availability of medical
products that are or will be included in the SNS in the event of a
public health emergency.
    (Comment 3) There were two comments regarding those provisions of
the interim final rule which allow SNS officials, or any entity that
manufactures (including labeling, packing, repackaging, or relabeling),
distributes, or stores the medical products to submit a request for an
exception or alternative to the labeling requirements specified in the
rule. One comment expressed concern that the rule permitted a SNS
official to apply for alternative labeling without the consent of the
product license holder. The comment acknowledged that there may be
situations that could require a SNS official to apply for a labeling
change without the license holder's consent, such as if a license
holder went out of business, but stated that in all other cases only
the product license holder (or, in the case of an investigational
product, the anticipated biologics license application (BLA) or new
drug application (NDA) holder) should be permitted to request an
exception or alternative to the labeling requirements specified in the
rule. The comment further suggested that any request by a SNS official
for an exception or alternative to the labeling requirements specified
in the rule should be accompanied by the written concurrence of the
product license holder.
    Similarly, another comment requested that the rule be amended to
allow only the product license holder or the sponsor of the
investigational new drug application (IND) to submit a request for a
labeling exception or alternative. The comment further requested that
the rule be amended to require SNS officials to first submit a request
for an alternative or exception to the labeling requirements specified
in the rule to the product license holder or IND sponsor for its
concurrence prior to submitting the request to FDA, and that the
license holder or IND sponsor be required to concur with the request
prior to SNS officials forwarding the request to FDA.
    (Response) The interim final rule allows for drug, biologic, and
device application holders, or sponsors of INDs or investigational
device exemptions (IDEs), to submit requests for labeling exceptions or
alternatives. Our experience to date with respect to the interim final
rule has been that BLA holders or applicants or sponsors of INDs have
submitted all of the requests received for labeling exceptions or
alternatives with the concurrence of SNS officials. We continue to
anticipate that many, if not all, of the requests submitted under this
rule will be submitted by manufacturers with the concurrence of SNS
officials prior to or at the time a specified lot, batch, or other unit
of the product is procured by the SNS, or when an investigational
product held in the SNS has been approved, licensed, or cleared.
Nonetheless, we also continue to recognize the need for additional
flexibility regarding products stored in the SNS to ensure their
availability in the event of a public health emergency. For example, in
order to prepare for an emergency, an SNS official or FDA Center
Director could determine there is a need for labeling exceptions or
alternatives to facilitate the use of a medical countermeasure during
an emergency. We note that in this example we anticipate that the
exception or alternative required would not result in any actual change
to the product labeling, but rather would allow for the use of the
product regardless of the current labeling.
    Thus, we continue to recognize that it may be necessary to allow
government officials, as well as any entity that manufactures
(including labeling, packing, repackaging, or relabeling), distributes,
or stores the medical product, to request exceptions or alternatives to
the labeling requirements specified in this rule to ensure that medical
products stored in the SNS are rapidly available for public use.

    (Comment 4) A comment suggested that FDA grant or deny a request
for an exception or alternative within 30 days from the receipt of any
request because such situations may call for rapid turnaround.
    (Response) We agree that there may be situations that could call
for a rapid turnaround in responding to a request for an exception or
alternative. The intent of this rule is to ensure the rapid
availability of medical countermeasures in the event of a public health
emergency, and FDA will respond to all requests regarding the SNS as
rapidly as possible. However, we do not believe that requiring FDA to
respond within a set timeframe without accounting for the variability
and complexity of each request would necessarily serve the public
health.
    (Comment 5) One comment asked what documentation would be provided
to the Department of Homeland Security's Customs and Border Protection
Agency (CBP) to allow importation of medical products that are the
subject of grants of exceptions or alternatives to labeling
requirements.
    (Response) This rule has no effect on the information that must be
submitted to CBP for imported medical products. That documentation
remains unchanged. FDA and CBP will be able to make appropriate
determinations regarding products for which exceptions or alternatives
have been granted without additional information at the time of entry.
    (Comment 6) A comment stated that while the rule appears to permit
only minor and technical labeling changes, it appears to be intended to
permit FDA to make additional labeling changes based on information
that becomes available to FDA after the initial label approval. The
comment argued that a change to previously approved labels based on
information not previously available alters the conditions under which
a product may be sold and may affect the product's value without
appropriate compensation to the manufacturer. Furthermore, the comment
expressed a general concern that such actions by the government may
violate the Constitution's Due Process and Takings provisions. The
comment further argued that even if such actions did not rise to the
level of Constitutional violations, they would be disincentives to
industry developing products with uses covered by the SNS. Finally, the
commenter was concerned that FDA may require a manufacturer of
investigational products to add language to the outer package labeling
of its product in the SNS after the product is licensed, approved, or
cleared.
    (Response) The concerns expressed in the comment are unfounded. We
do not agree that FDA's grant of an exception or alternative to certain
FDA labeling requirements under the rule would adversely affect a
product's value. This rule applies to medical products that are or will
be held in the SNS only. The purpose of the rule is to provide for
exceptions or alternatives to certain regulatory requirements if
compliance with the requirements could adversely affect the safety,
effectiveness, or availability of these products. Therefore, we would
anticipate that this rule could encourage, as opposed to discourage,
the procurement of medical products by the SNS.
    We reiterate that this rule is narrowly drafted to create necessary
exceptions or alternatives to specified labeling requirements to ensure
that medical products stored in the SNS are available for public use in
the event of an emergency. To date, we have received six requests for
exceptions or alternatives to labeling requirements, all of which have
been initiated by BLA holders or applicants or sponsors of IND
applications, with the concurrence of SNS officials. Our experience to
date is that this rule does not create disincentives to participation
in the SNS, and we note that the comment did not contain any data or
information to substantiate this concern. Furthermore, to the extent
that the comment is arguing that this rule violates the Due Process and
Takings clauses of the Constitution by affecting a product's value
without appropriate compensation to the manufacturer, as discussed
previously, we disagree. As we have explained, this rule will not
adversely affect the value of a product. We do not believe that this
rule in any way violates the Constitution.
    (Comment 7) One comment expressed concern that relabeling a product
suggests product manipulation. The comment stated that over labeling or
relabeling creates the possibility for error, damage to the product and
potential confusion by the SNS and, ultimately, for the user for whom
the product is intended. Further, any of these possibilities may
increase product liability exposure for the manufacturer.
    (Response) The concerns expressed in the comment are unfounded. As
stated in the preamble to the interim final rule, we recognize that
relabeling is a potentially time-consuming, costly, and labor-intensive
process that could possibly cause product mishandling, sabotage or
diversion, or could cause products to be unavailable for dispensing in
the event of an emergency. Accordingly, this rule is specifically
designed to allow FDA Center Directors to grant exceptions or
alternatives to certain labeling requirements for medical products in
the SNS to mitigate the need for relabeling. We also note that since
the development of the SNS, manufacturers, in conjunction with FDA, the
Centers for Disease Control and Prevention/SNS officials and the
Department of Health and Human Services/Biomedical Advanced Research
and Development Authority, have developed innovative labeling
mechanisms for certain products through which relabeling an
investigative product requires minimal manipulation post-licensure
(e.g., ``zipper'' labels or ``tear-off'' labels on the actual product
container).
    Regarding the product liability concern, this rule does not
authorize the use of unapproved products, or of approved products for
unapproved uses in an emergency. This rule instead permits a Center
Director to authorize an exception or alternative from certain labeling
requirements. Notably, with regard to other product liability concerns
the commenter may have, the Public Readiness and Emergency Preparedness
(PREP) Act is intended to address tort liability for manufacturers in
such circumstances (42 U.S.C. 247d-6(d)).
    (Comment 8) A comment stated that the rule would appear to place
burdens on a manufacturer. For example, the comment states that the
rule does not exempt a sponsor from the requirement that it include in
the company's annual report to FDA changes in labeling even when the
government initiated the change without input from the manufacturer.
The comment suggests that therefore, the company will need to track the
activities of the SNS after the product has been distributed.
    (Response) FDA clarifies that under 21 CFR 201.26(e), a sponsor or
applicant would only have to report a grant of a request for an
exception or alternative of labeling requirements if the sponsor or
applicant requested the change. We also note that we expect that in the
majority of cases, this exception or alternative would be granted
during the product approval process. Accordingly, FDA does not expect
this rule to impose burdensome reporting requirements on manufacturers.

III. Legal Authority

    In this final rule, FDA is amending regulations pertaining to the
content and format of medical product labeling. The provisions of this
rule allow FDA to grant exceptions or alternatives to certain of those
labeling requirements. The labeling regulations to which

exceptions or alternatives are permitted under this rule were issued by
FDA under authority of the FD&C Act and the PHS Act to mandate
particular ways that firms must satisfy the broad requirements and
prohibitions in those statutes, such as the prohibition on false and
misleading drug and device labeling. As described in section II of this
document, and in the interim final rule, FDA has determined that
circumstances may arise in which compliance with those regulatory
mandates could adversely affect the safety, effectiveness, or
availability of certain medical products that are or will be included
in the SNS. Moreover, due to the unique nature of the SNS, those
products could deviate from particular mandates of existing labeling
regulations without violating the broad statutory requirements and
prohibitions in the FD&C Act and the PHS Act. For those reasons, FDA is
exercising its authority to regulate labeling by modifying the existing
regulations in a way that allows exceptions or alternatives for medical
products that are or will be included in the SNS.
    As explained in the interim final rule, FDA has various sources of
authority to issue labeling regulations, including, for example,
sections 201(n), 502(a), and 701(a) of the FD&C Act (21 U.S.C. 321(n),
352(a), and 371(a)) for drugs (including biological products) and
devices, and sections 351(a)(1)(A) and 351(a)(2)(A) of the PHS Act (42
U.S.C. 262(a)(1)(A) and (a)(2)(A)) for biological products. In
addition, as more fully discussed in the interim final rule, FDA has
concluded that exceptions or alternatives granted under this rule will
not render products misbranded due to the additional safeguards and
conditions that may be required when an exception or alternative is
granted, as well as the unique storage, deployment and distribution
considerations essential to the SNS.

IV. Analysis of Impacts

    FDA has examined the impacts of the final rule under Executive
Order 12866, Executive Order 13563, the Regulatory Flexibility Act (5
U.S.C. 601-612), and the Unfunded Mandates Reform Act of 1995 (Pub. L.
104-4). Executive Orders 12866 and 13563 direct Agencies to assess all
costs and benefits of available regulatory alternatives and, when
regulation is necessary, to select regulatory approaches that maximize
net benefits (including potential economic, environmental, public
health and safety, and other advantages; distributive impacts; and
equity). The analysis of costs and benefits of available regulatory
alternatives contained in the interim final rule (72 FR 73589 at 73596)
is adopted without change in this final rule. By now reaffirming that
interim final rule, FDA has not imposed any new requirements.
Therefore, there are no additional costs and benefits associated with
this final rule.
    The Regulatory Flexibility Act requires Agencies to analyze
regulatory options that would minimize any significant impact of a rule
on small entities. Because this final rule does not make any changes to
the interim final rule or our analysis included therein, the Agency
certifies that the final rule will not have a significant economic
impact on a substantial number of small entities.
    Section 202(a) of the Unfunded Mandates Reform Act of 1995 requires
that Agencies prepare a written statement, which includes an assessment
of anticipated costs and benefits, before issuing ``any rule that
includes any Federal mandate that may result in the expenditure by
State, local, and tribal governments, in the aggregate, or by the
private sector, of $100,000,000 or more (adjusted annually for
inflation) in any one year.'' The current threshold after adjustment
for inflation is $136 million, using the most current (2010) Implicit
Price Deflator for the Gross Domestic Product. FDA does not expect this
final rule to result in any 1-year expenditure that would meet or
exceed this amount.

V. The Paperwork Reduction Act

    Sections 201.26(b), 610.68(b), 801.128(b), and 809.11(b) of this
final rule contain information collection requirements that were
submitted for review and approval to the Director of the Office of
Management and Budget (OMB), as required by section 3507(d) of the
Paperwork Reduction Act of 1995. The information collection
requirements were approved and assigned OMB control number 0910-0614
(expires August 31, 2014).

VI. Environmental Impact

    The Agency has determined under 21 CFR 25.30(k) 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.

VII. Federalism

    In the Federal Register of October 5, 2011 (76 FR 61565), FDA
published a notification of preemption review, which was conducted in
response to a memorandum from the President that directed Federal
Agencies to review recently issued regulations to ensure that any
statements concerning preemption can be justified under legal
principles governing preemption, including those outlined in Executive
Order 13132. In this notification, FDA announced its determination that
the preamble to the interim final rule referred to statements
concerning preemption that are not justified under legal principles
governing preemption. FDA has analyzed this final rule in accordance
with the principles set forth in Executive Order 13132 and has
determined that this rule is consistent with the Executive Order.
Section 4(a) of this Executive Order requires agencies to ``construe *
* * a Federal statute to preempt State law only where the statute
contains an express preemption provision or there is some other clear
evidence that the Congress intended preemption of State law, or where
the exercise of State authority conflicts with the exercise of Federal
authority under the Federal statute.'' In this rule, FDA is adopting as
a final rule regulations permitting FDA Center Directors to grant
exceptions or alternatives to certain regulatory labeling requirements
applicable to medical products that are or will be included in the SNS.
Certain State requirements regarding the format and content of
nonprescription drug labeling and/or labeling of approved medical
devices may be subject to the express preemption provisions in section
751 of the FD&C Act (21 U.S.C. 379r) (nonprescription drugs) and
section 521 of the FD&C Act (21 U.S.C. 360k) (approved medical
devices). We also note that even where an express preemption provision
is not applicable, implied preemption may arise.
    Accordingly, the interim final rule amending 21 CFR parts 201, 312,
314, 601, 610, 801, 807, 809, 812, and 814 which was published at 72 FR
73589 on December 28, 2007, is adopted as a final rule without change.

    Dated: February 1, 2012.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2012-2558 Filed 2-3-12; 8:45 am]
BILLING CODE 4160-01-P


13308 Federal Register / Vol. 68, No. 53 / Wednesday, March 19, 2003 / Notices II. What Action is the Agency Taking?

This notice announces receipt by the Agency of applications from registrants to cancel three pesticide products registered under section 3 of FIFRA. These registrations are listed in sequence by registration number in Table 1 of this unit.

TABLE 1.   PHOSMET REGISTRATIONS WITH PENDING REQUESTS FOR CANCELLATION Registration No. Product name 2724   169 Vet Kem Kemolate Emulsifiable Liquid 10163   167 Imidan 50 WP Garden and Home Insecticide 28293   15 Unicorn Phosmet Insecticidal Dust for Dogs Unless a request is withdrawn by the registrant within 180 days of publication of this notice, orders will be issued canceling all of these registrations. Users of these pesticides or anyone else desiring the retention of a registration should contact the applicable registrant directly during this 180   day period. Table 2 of this unit includes the names and addresses of record for all registrants of the products in Table 1 of this unit, in sequence by EPA company number:

TABLE 2.   REGISTRANTS REQUESTING VOLUNTARY CANCELLATION EPA Company No. Company name and address 2724 Wellmark International 1100 East Woodfield Road, Suite 500 Schaumburg, IL 60173 10163 Gowan Company 370 S. Main Street Yuma, AZ 85364 28293 Unicorn Laboratories 12385 Automobile Blvd. Clearwater, FL 33762 III. What is the Agency's Authority for Taking this Action?

Section 6( f)( 1) of FIFRA provides that a registrant of a pesticide product may at any time request that any of its pesticide registrations be canceled. FIFRA further provides that, before acting on the request, EPA must publish a notice of receipt of any such request in the Federal Register. Thereafter, the Administrator may approve such a request.

IV. Procedures for Withdrawal of Request Registrants who choose to withdraw a request for cancellation must submit such withdrawal in writing to the person listed under FOR FURTHER INFORMATION CONTACT, postmarked before September 15, 2003. This written withdrawal of the request for cancellation will apply only to the applicable FIFRA section 6( f)( 1) request listed in this notice. If the product( s) have been subject to a previous cancellation action, the effective date of cancellation and all other provisions of any earlier cancellation action are controlling. The withdrawal request must also include a commitment to pay any reregistration fees due, and to fulfill any applicable unsatisfied data requirements.

V. Provisions for Disposition of Existing Stocks In accordance with the Phosmet Interim Reregistration Eligibility Decision ( IRED) document, dated October 30, 2001, and the Memorandum of Agreement signed by Gowan Company on October 20, 2001, the following two products, as identified in Table 1, are prohibited from sale: EPA Reg. Nos. 10163   167 and 28293   15. In addition, Wellmark International is prohibited from selling or distributing existing stocks of phosmet product EPA Reg. No. 2724   169, after March 30, 2003. Wellmark International signed an Agreement where the signatory, and non signatory registrants agreed to: Stop formulating phosmet product ( EPA Reg. No. 2724   169) for the dog use on August 30, 2002; and stop sales of the product on March 30, 2003. Sales of the subject product at the retail level can continue until supplies are exhausted; and existing stocks of phosmet technical not formulated into the dog use product will be used to formulate livestock use products. This is in accordance with the Agency's statement of policy as prescribed in the Federal Register of June 26, 1991 ( 56 FR 29362) ( FRL   3846   4). Exceptions will be made if EPA determines that a product poses a risk concern, or is in noncompliance with reregistration requirements, or is subject to a Data Call In. In all cases, product specific disposition dates will be given in the cancellation orders. Existing stocks are those stocks of registered pesticide products which are currently in the United States and which have been packaged, labeled, and released for shipment prior to the effective date of the cancellation action. Unless the provisions of an earlier order apply, existing stocks already in the hands of dealers or users can be distributed, sold, or used legally until they are exhausted, provided that such further sale and use comply with the EPA approved label and labeling of the affected product. Exception to these general rules will be made in specific cases when more stringent restrictions on sale, distribution, or use of the products or their ingredients have already been imposed, as in a Special Review action, or where the Agency has identified significant potential risk concerns associated with a particular chemical.

List of Subjects Environmental protection, organophosphate, pesticides and pests.

Dated: March 4, 2003. Lois A. Rossi, Director, Information Resources Services Division, Office of Pesticide Programs. [ FR Doc. 03   6236 Filed 3   18   03; 8: 45 am]

BILLING CODE 6560   50   S ENVIRONMENTAL PROTECTION AGENCY [ OPP   2003   0045; FRL   7293   7]

Triallate; Completion of Comment Period for Reregistration Eligibility Decision AGENCY: Environmental Protection Agency ( EPA). ACTION: Notice.

SUMMARY: This notice, pursuant to section 4( g)( 2) of the Federal Insecticide, Fungicide, and Rodenticide Act ( FIFRA), concludes the comment period for the Reregistration Eligibility Decision ( RED) for triallate. No comments were received for triallate. FOR FURTHER INFORMATION CONTACT: Dirk V. Helder, Special Review and Reregistration Division ( 7508C), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460   0001; telephone number: ( 703) 305   4610; fax number: ( 703) 308   8041; email address: helder. dirk@ epa. gov. SUPPLEMENTARY INFORMATION:

I. General Information A. Does this Action Apply to Me? This action is directed to the public in general. This action may, however, be of interest to persons who are or may be required to conduct testing of chemical substances under the Federal VerDate Jan< 31> 2003 18: 09 Mar 18, 2003 Jkt 200001 PO 00000 Frm 00057 Fmt 4703 Sfmt 4703 E:\ FR\ FM\ 19MRN1. SGM 19MRN1 13309 Federal Register / Vol. 68, No. 53 / Wednesday, March 19, 2003 / Notices Insecticide, Fungicide, and Rodenticide Act ( FIFRA) or the Federal Food, Drug, and Cosmetic Act ( FFDCA); environmental, human health, and agricultural advocates; pesticide users; and the public interested in the use of pesticides. Since other entities may also be interested, the Agency has not attempted to describe all the specific entities that may be affected by this action. If you have any questions regarding the applicability of this action to a particular entity, consult the person listed under FOR FURTHER INFORMATION CONTACT.

B. How Can I Get Copies of this Document and Other Related Information?

1. Docket. EPA has established an official public docket for this action under docket identification ( ID) number OPP   2003   0045. The official public docket consists of the documents specifically referenced in this action, any public comments received, and other information related to this action. Although a part of the official docket, the public docket does not include Confidential Business Information ( CBI) or other information whose disclosure is restricted by statute. The official public docket is the collection of materials that is available for public viewing at the Public Information and Records Integrity Branch ( PIRIB), Rm. 119, Crystal Mall # 2, 1921 Jefferson Davis Hwy., Arlington, VA. This docket facility is open from 8: 30 a. m. to 4 p. m., Monday through Friday, excluding legal holidays. The docket telephone number is ( 703) 305   5805. 2. Electronic access. You may access this Federal Register document electronically through the EPA Internet under the `` Federal Register'' listings at http:// www. epa. gov/ fedrgstr/. An electronic version of the public docket is available through EPA's electronic public docket and comment system, EPA Dockets. You may use EPA Dockets at http:// www. epa. gov/ edocket/ to view public comments, access the index listing of the contents of the official public docket, and to access those documents in the public docket that are available electronically. Although not all docket materials may be available electronically, you may still access any of the publicly available docket materials through the docket facility identified in Unit I. B. 1. Once in the system, select `` search,'' then key in the appropriate docket ID number. II. Background A. What Action is the Agency Taking? This notice constitutes and announces the closing of the comment period for the triallate RED. The Agency published a notice in the Federal Register of May 23, 2001 ( 66 FR 28469) ( FRL   6775   9) and a correction in the Federal Register on June 25, 2001 ( 66 FR 33684) ( FRL   6788   1) announcing the availability and start of a 60   day public comment period on the Reregistration Eligibility Decision document for the pesticide active ingredient triallate. This RED was issued as a final document with a 60   day comment period, which closed on July 23, 2001. In this RED, EPA provided its regulatory position on the current registered use of triallate and set forth certain data requirements and label amendments for product reregistration eligibility. A copy of the triallate RED can be found under docket control number OPP   34226A or on the EPA website at http:// www. epa. gov/ pesticides/ reregistration/ status. htm.

B. What is the Agency's Authority for Taking this Action? The legal authority for this RED falls under FIFRA, as amended in 1988 and 1996. Section 4( g)( 2)( A) of FIFRA directs that, after submission of all data concerning a pesticide active ingredient, `` the Administrator shall determine whether pesticides containing such active ingredients are eligible for reregistration,'' and either reregister products or take `` other appropriate regulatory action.''

List of Subjects Environmental protection, Pesticide Tolerances.

Dated: March 4, 2003. Lois A. Rossi, Director, Special Review and Reregistration Division, Office of Pesticide Programs. [ FR Doc. 03   6299 Filed 3   18   03; 8: 45 am]

BILLING CODE 6560   50   S ENVIRONMENTAL PROTECTION AGENCY [ OPP   2003   0013; FRL   7288   3]

Fenbutatin Oxide; Completion of Comment Period for Tolerance Reassessment Progress and Interim Risk Management Decision AGENCY: Environmental Protection Agency ( EPA). ACTION: Notice.

SUMMARY: This notice, pursuant to section 4( g)( 2) of the Federal Insecticide, Fungicide, and Rodenticide Act ( FIFRA), concludes the 30   day comment period for the Tolerance Reassessment Progress and Interim Risk Management Decision ( TRED) for fenbutatin oxide. No comments were submitted. These tolerances are now reassessed and considered safe under the Federal Food, Drug, and Cosmetic Act ( FFDCA), as amended by the Food Quality Protection Act of 1996 ( FQPA). FOR FURTHER INFORMATION CONTACT: Beth Edwards, Special Review and Reregistration Division ( 7508C), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460   0001; telephone number: ( 703) 305   5400; fax number: ( 703) 308   8041; email address: edwards. beth@ epa. gov. SUPPLEMENTARY INFORMATION:

I. General Information A. Does this Action Apply to Me? This action is directed to the public in general. This action may, however, be of interest to persons who are or may be required to conduct testing of chemical substances under the Federal Insecticide, Fungicide, and Rodenticide Act ( FIFRA) or the Federal Food, Drug, and Cosmetic Act ( FFDCA); environmental, human health, and agricultural advocates; pesticide users; and the public interested in the use of pesticides. Since other entities may also be interested, the Agency has not attempted to describe all the specific entities that may be affected by this action. If you have any questions regarding the applicability of this action to a particular entity, consult the person listed under FOR FURTHER INFORMATION CONTACT.

B. How Can I Get Copies of this Document and Other Related Information? 1. Docket. EPA has established an official public docket for this action under docket identification ( ID) number OPP   2003   0013. The official public docket consists of the documents specifically referenced in this action, any public comments received, and other information related to this action. Although a part of the official docket, the public docket does not include Confidential Business Information ( CBI) or other information whose disclosure is restricted by statute. The official public docket is the collection of materials that is available for public viewing at the Public Information and Records Integrity Branch ( PIRIB), Rm. 119, Crystal Mall # 2, 1921 Jefferson Davis Hwy., Arlington, VA. This docket facility is open from 8: 30 a. m. to 4 p. m.,

VerDate Jan< 31> 2003 18: 09 Mar 18, 2003 Jkt 200001 PO 00000 Frm 00058 Fmt 4703 Sfmt 4703 E:\ FR\ FM\ 19MRN1. SGM 19MRN1


[Federal Register: November 13, 2007 (Volume 72, Number 218)]
[Notices]
[Page 63951-63956]
[DOCID:fr13no07-110]

=======================================================================
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DEPARTMENT OF TRANSPORTATION

Office of the Secretary of Transportation

[Docket Nos. OST-2007-0004, FHWA-2007-0004, and FTA-2007-0004]

Solicitation of Applications for Funding of Congestion-Reduction
Demonstration Initiatives

AGENCIES: Office of the Secretary of Transportation (``OST''); Federal
Highway Administration (``FHWA''); Federal Transit Administration
(``FTA''), Department of Transportation (``DOT'').

ACTION: Notice of solicitation for applications to enter into
agreements with the U.S. Department of Transportation (the
``Department'') for funding under any or all of the following programs
(collectively, the ``Funding Programs'') to support qualified
congestion-reduction demonstration initiatives: (i) FHWA's Delta Region
Transportation Development Program (Sec.  1308 of Public Law 109-59)
(the ``Delta Region Program''); (ii) FHWA's Ferry Boat Discretionary
Program (23 U.S.C. 147) (the ``Ferry Boat Program''); (iii) FHWA's
Highways for Life Pilot Program (Sec.  1502 of Public Law 109-59) (the
``HfL Program''); (iv) FHWA's Innovative Bridge Research and Deployment
Program (23 U.S.C. 503(b)) (the ``Innovative Bridge Program''); (v)
FHWA's Interstate Maintenance Discretionary Program (23 U.S.C. 118(c))
(the ``IMD Program''); (vi) FHWA's Public Lands Highway Discretionary
Program (23 U.S.C. 202-204) (the ``Public Lands Program''); (vii)
FHWA's Transportation, Community, and System Preservation Program
(Sec.  1117 of Public Law 109-59) (the ``TCSP Program''); (viii) FHWA's
Truck Parking Facilities Pilot Program (Sec.  1305 of Public Law 109-
59) (the ``Truck Parking Program''); (ix) FTA's capital program for Bus
and Bus-Related Facilities (49 U.S.C. 5309) (the ``Bus Program''); (x)
FTA's capital program for New Fixed Guideway Facilities, including
``Small Starts'' projects (49 U.S.C. 5309, 49 U.S.C. 5309(e)) (the
``Small Starts Program''); (xi) FTA's Alternatives Analysis Program (49
U.S.C. 5339); and (xii) any other discretionary program administered by
the Department and designated by the Secretary as a source of funding
under such agreements.

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SUMMARY: This Notice solicits proposals to enter into certain
agreements with the U.S. Department of Transportation (the
``Department''). Through these agreements, the Department intends to
support congestion pricing along with complementary transportation
solutions proposed by jurisdictions designated as recipients of Federal
assistance in accordance with this Notice (each, a ``qualified
jurisdiction''). Funds made available by the Department to qualified
jurisdictions may include such sums as may be available for obligation
in the Department's discretion during Fiscal Year 2008, including funds
designated by law to support the Department's Congestion Initiative, as
proposed in the President's Fiscal Year 2008 Budget. \1\
---------------------------------------------------------------------------

    \1\ Budget of the United States Government, Fiscal Year 2008
(http://www.whitehouse.gov/omb/budget/fy2008/transportation.html).

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

    The Department reserves the right to solicit candidates for funding
described herein by means other than this Notice. The Department
expects to implement the procedures and criteria set forth in this
Notice; however, such procedures and criteria shall not be binding on
the Department.

DATES: Applicants wishing to become qualified jurisdictions must submit
their applications on or before December 31, 2007. Late-filed
applications will be considered to the extent practical. The Department
intends to announce agreements with qualified jurisdictions in Fiscal
Year 2008.

ADDRESSES: Applicants wishing to become qualified jurisdictions may
file their applications electronically via e-mail to Thomas M. McNamara
at<EMAIL_ADDRESS>or through ``grants.gov'' at http://www.grants.gov.
 (Please note that solely for purposes of this

solicitation, the Department prefers, but does not require, submission
of applications by means of the e-mail address above). In the event
that either of the forgoing options for submission would impose a
hardship on an applicant, the applicant may request an exception by
email to the email address above. If an exception is granted, the
applicant may send a single copy of its application by U.S. Post or
express mail to: Thomas M. McNamara, Office of the Assistant Secretary
for Transportation Policy, U.S. Department of Transportation, 1200 New
Jersey Ave., SE., W84-322, Washington, DC 20590. The Department shall
only deem applications received via email or through grants.gov (or by
U.S. Post or express mail pursuant to an exception) as provided above
to be properly filed with the Department. The Department shall deem a
single application filed pursuant to this Notice to be properly filed
with each of the Funding Programs identified therein, and will not
require separate applications to each such program, unless the
Department determines otherwise in its discretion. Before using
grants.gov for the first time, each organization must register and
create an institutional profile at the grants.gov Web site. Applicants
planning to apply electronically are encouraged to begin the process of
registration on the grants.gov Web site well in advance of the
submission deadline. Registration is a multi-step process, which may
take several weeks to complete before an application can be submitted.

FOR FURTHER INFORMATION CONTACT: Please address questions concerning
this Notice to David B. Horner, Deputy Assistant Secretary for
Transportation Policy, U.S. Department of Transportation, at 202-689-
4464 (or by e-mail at david.horner@dot.gov). Please address technical
questions concerning project development to Thomas M. McNamara at 202-
366-4462 (or by e-mail at thomas.mcnamara@dot.gov).

SUPPLEMENTARY INFORMATION:

A. Background

    Crisis of Congestion. Traffic congestion affects people in nearly
every aspect of their daily lives--where they live, where they work,
where they shop, and how much they pay for goods and services.
According to 2005 figures, in certain metropolitan areas the average
rush hour driver loses as many as 60 hours per year to travel delay--
the equivalent of one and a half full work weeks, amounting annually to
a ``congestion tax'' of approximately $1,200 per peak time traveler in
wasted time and fuel. \2\ Nationwide, congestion imposes costs on the
economy of at least $78 billion per year. \3\ The costs of congestion
are higher, however, after taking into account the significant cost of
unreliability to drivers and businesses, the environmental impacts of
idle-related auto emissions, increased gasoline prices and the
immobility of labor markets that result from congestion, all of which
substantially affect interstate commerce.
---------------------------------------------------------------------------

    \2\ Texas Transportation Institute (``TTI''), 2007 Urban
Mobility Report, September 2007.
    \3\ TTI, 2007 Urban Mobility Report.
---------------------------------------------------------------------------

    Traffic congestion also has a substantial negative impact upon the
quality of life of many American families. In a 2005 survey, for
example, 52% of Northern Virginia commuters reported that their travel
times to work had increased in the past year,\4\ leading 70% of working
parents to report having insufficient time to spend with their children
and 63% of respondents to report having insufficient time to spend with
their spouses.\5\ Nationally, in a 2005 survey conducted by the
National League of Cities, 35% of U.S. citizens reported traffic
congestion as the most deteriorated living condition in their cities
over the past five years; 85% responded that traffic congestion was as
bad as, or worse than, it was in the previous year.\6\ Similarly, in a
2001

survey conducted by the U.S. Conference of Mayors, 79% of Americans
from ten metropolitan areas reported that congestion had worsened in
the prior five years; 50% believe it has become ``much worse.'' \7\
---------------------------------------------------------------------------

    \4\ Northern Virginia Transportation Alliance 2005 Survey
(http://www.nvta.org/content.asp?contentid=1174).

    \5\ Virginia Department of Transportation.
    \6\ National League of Cities survey of cities (2005).
    \7\ U.S. Conference of Mayors survey on traffic congestion
(2001).
---------------------------------------------------------------------------

    Solicitation. This Notice solicits proposals to enter into certain
agreements with the U.S. Department of Transportation (the
``Department''). Through these agreements, the Department intends to
support congestion pricing along with complementary transportation
solutions proposed by jurisdictions designated as recipients of Federal
assistance in accordance with this Notice (each, a ``qualified
jurisdiction''). Funds made available by the Department to qualified
jurisdictions may include such sums as may be available for obligation
in the Department's discretion during Fiscal Year 2008, including funds
designated by law to support the Department's Congestion Initiative, as
proposed in the President's Fiscal Year 2008 Budget.\8\
---------------------------------------------------------------------------

    \8\ Budget of the United States Government, Fiscal Year 2008
(http://www.whitehouse.gov/omb/budget/fy2008/transportation.html).

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

    The Department expects to award funding only for those proposals
that integrate innovative transit strategies, new transportation
technologies and direct highway pricing during congested periods. In
return for their agreement to adopt such strategies, the Department
will support qualified jurisdictions with financial resources
identified in this Notice, regulatory flexibility, and dedicated
expertise and personnel. Because the Secretary generally allocates
discretionary highway grant funds to State DOTs, applicants that are
non-State DOTs applying for discretionary highway funds made available
under any of the specified Funding Programs should partner with or
submit an application through the State DOT for these funds.

B. Funding Programs

    The Department proposes to support qualified jurisdictions through
the following programs:
    (i) FHWA's Delta Region Program. The Department may obligate all or
part of such sums available for obligation in its discretion under the
Delta Region Program in Fiscal Year 2008 to support eligible projects
sponsored by qualified jurisdictions. Under section 1308 of the Safe,
Accountable, Flexible, Efficient Transportation Equity Act: A Legacy
for Users (or ``SAFETEA-LU'') (Pub. L. 109-59, August 10, 2005), the
FHWA Administrator, acting on behalf of the Secretary, may fund
projects that support and encourage multi-state transportation planning
and corridor development, provide for transportation project
development, facilitate transportation decision making, and support
transportation construction in the 240 counties and parishes within the
eight states comprising the Delta Regional Authority's region (Alabama,
Arkansas, Illinois, Kentucky, Louisiana, Mississippi, Missouri, and
Tennessee). Eligible projects must either (a) traverse more than one
State and carry interstate commerce or (b) have been identified by the
Delta Regional Authority as highways of regional significance, (i.e.,
on or expected to be on the Delta Development Highway System).
    Applicants must address the standard requirements for an
application to the Delta Region Transportation Development Program as
described in last year's request for applications, found at http://www.fhwa.dot.gov/planning/s1308fy07drtdp.htm.
 The application

procedures and deadlines provided in this Notice supersede those set
forth in the forgoing hyperlink.
    (ii) FHWA's Ferry Boat Program. The Department may obligate all or
part of such sums available for obligation in its discretion under the
Ferry Boat Program in Fiscal Year 2008 to support eligible projects
sponsored by qualified jurisdictions. Under section 1801 of SAFETEA-LU,
the FHWA Administrator, acting on behalf of the Secretary, may fund
projects that involve the construction of ferry boats and ferry
terminal facilities in accordance with 23 U.S.C. 147.
    Ferry Boat Program Funds are available for construction/improvement
to ferry boats or ferry boat terminals where, among other things: (a)
It is not feasible to build a bridge, tunnel, combination thereof, or
other normal highway structure in lieu of the use of such ferry; (b)
the operation of the ferry shall be on a route classified as a public
road within the State or Territory and which has not been designated as
a route on the Interstate System; and (c) such ferry boat or ferry
terminal facility shall be publicly owned or operated or majority
publicly owned if the Secretary determines, with respect to a majority
publicly owned ferry or ferry terminal facility, that such ferry boat
or ferry terminal facility provides substantial public benefits.
Eligible projects may include either ferry boats that carry both cars
and passengers, or ferry boats carrying passengers only.
    Applicants must address the standard requirements for an
application to the Ferry Boat Program found at: http://www.fhwa.dot.gov/discretionary/fbdinfo.cfm.
 The application procedures

and deadlines provided in this Notice supersede those set forth in the
forgoing hyperlink.
    (iii) FHWA's HfL Program. The Department may obligate all or part
of such sums available for obligation in its discretion under the HfL
Program in Fiscal Year 2008 to support eligible projects sponsored by
qualified jurisdictions. Under section 1502 of SAFETEA-LU, the FHWA
Administrator, acting on behalf of the Secretary, may fund projects
otherwise eligible for assistance under chapter 1 of title 23, United
States Code that, among other things, (a) use innovative technologies,
manufacturing processes, financing or contracting methods that improve
safety, reduce congestion due to construction, and improve quality, and
(b) constructs, reconstructs or rehabilitates a route or connection on
an eligible Federal-aid highway.
    Applicants must address the standard requirements for an
application to the HfL Program as described in an earlier solicitation
for projects, found at http://www.fhwa.dot.gov/hfl/application_memo.cfm.
 The application procedures and deadlines provided in this

Notice supersede those set forth in the forgoing hyperlink.
    (iv) FHWA's Innovative Bridge Program. The Department may obligate
all or part of such sums available for obligation in its discretion
under the Innovative Bridge Program in Fiscal Year 2008 to support
eligible projects sponsored by qualified jurisdictions. Under section
5202(b) of SAFETEA-LU, the FHWA Administrator, acting on behalf of the
Secretary, may fund projects that promote, demonstrate, evaluate, and
document the application of innovative designs, materials, and
construction methods in the construction, repair, and rehabilitation of
bridge and other highway structures, for purposes including--but not
limited to--increasing safety and reducing construction time and
traffic congestion. Detailed Innovative Bridge Program goals are
identified in 23 U.S.C. 503(b)(2). Eligible projects may be on any
public roadway, including State and locally funded projects. Funds may
be used for costs of preliminary engineering, repair, rehabilitation,
or construction of bridges or other highway structures, and costs of
project performance evaluation and performance monitoring of the
structure following construction.
    Applicants must address the standard requirements for an
application to the Innovative Bridge Program found at http://www.fhwa.dot.gov/bridge/ibrd/032807.cfm.
 The application procedures and

deadlines provided in this Notice

supersede those set forth in the forgoing hyperlink.
    (v) FHWA's IMD Program. The Department may obligate all or part of
such sums available for obligation in its discretion under the IMD
Program in Fiscal Year 2008 to support eligible projects sponsored by
qualified jurisdictions. Under 23 U.S.C. 118(c), the FHWA
Administrator, acting on behalf of the Secretary, may fund projects
that involve resurfacing, restoration, rehabilitation and
reconstruction (``4R'') work, including added lanes to increase
capacity, on most existing Interstate System routes. Ineligible
projects include those that are located on (a) any highway designated
as a part of the Interstate System under 23 U.S.C. 139, as in effect
before the enactment of TEA-21, (b) any toll road on the Interstate
System not subject to an agreement under 23 U.S.C. 119(e), as in effect
on December 17, 1991, or (c) any highway added to the Interstate System
under 23 U.S.C. 103(c)(4) and section 1105(e)(5)(A) of the Intermodal
Surface Transportation Efficiency Act of 1991. Any proposed or future
Interstate route is also not eligible for IMD funds. A full listing of
the statutory criteria for eligibility of IMD projects is provided in
23 U.S.C. 118(c).
    Applicants must address the standard requirements for an
application to the Interstate Maintenance Program found at http://www.fhwa.dot.gov/discretionary/imdinfo.cfm.
 The application procedures

and deadlines provided in this Notice supersede those set forth in the
forgoing hyperlink.
    (vi) FHWA's Public Lands Program. The Department may obligate all
or part of such sums available for obligation in its discretion under
the Public Lands Program in Fiscal Year 2008 to support eligible
projects sponsored by qualified jurisdictions. Under 23 U.S.C.
204(b)(5), the FHWA Administrator, acting on behalf of the Secretary,
may fund ``any kind of transportation project eligible for assistance
under title 23, United States Code, that is within, adjacent to, or
provides access to'' Federal lands or facilities. Under the provisions
of 23 U.S.C. 204(b)(1)(A), Public Lands Program funds are available for
transportation planning, research, engineering, and construction of the
highways, roads, and parkways, and of transit facilities within the
Federal public lands. Under the provisions of 23 U.S.C. 204(b)(1)(B),
Public Lands Program funds are also available for operation and
maintenance of transit facilities located on Federal public lands.
    Applicants must address the standard requirements for an
application to the Public Lands Program found at http://www.fhwa.dot.gov/discretionary/plhcurrsola3.cfm.
 The application

procedures and deadlines provided in this Notice supersede those set
forth in the forgoing hyperlink.
    (vii) FHWA's TCSP Program. The Department may obligate all or part
of such sums available for obligation in its discretion under the TCSP
Program in Fiscal Year 2008 to support eligible projects sponsored by
qualified jurisdictions. Under section 1117 of SAFETEA-LU, the FHWA
Administrator, acting on behalf of the Secretary, may fund planning
grants, implementation grants, and research to investigate and address
the relationships between transportation, community, and system
preservation and to identify private sector-based initiatives to
improve such relationships.
    States, metropolitan planning organizations (``MPOs''), local
governments (including, but not limited to, towns, cities, public
transit agencies) and tribal governments are eligible for TCSP Program
discretionary grants. Non-governmental organizations that have projects
they wish to see funded under this program are encouraged to partner
with an eligible recipient as the project sponsor. Activities eligible
for TCSP Program funding include activities that are eligible for
Federal highway and transit funding (title 23, U.S.C., or Chapter 53 of
title 49, U.S.C.) or other activities determined by the Secretary to be
appropriate. Grants may be used to plan and implement strategies which
improve the efficiency of the transportation system, reduce
environmental impacts of transportation, reduce the need for costly
future public infrastructure investments, ensure efficient access to
jobs, services and centers of trade, and examine development patterns
and identify strategies to encourage private sector development
patterns which achieve these goals.
    Applicants must address the standard requirements for an
application to the TCSP Program found at http://www.fhwa.dot.gov/tcsp/pi_tcsp.htm.
 The application procedures and deadlines provided in this

Notice supersede those set forth in the forgoing hyperlink.
    (viii) FHWA's Truck Parking Program. The Department may obligate
all or part of such sums available for obligation in its discretion
under the Truck Parking Program in Fiscal Year 2008 to support eligible
projects sponsored by qualified jurisdictions. As directed by section
1305 of SAFETEA-LU, the Secretary established a pilot program to
address the shortage of long-term parking for commercial motor vehicles
on the National Highway System. States, MPOs and local governments are
eligible to receive discretionary grants available under this pilot
program. Section 1305 allows for a wide range of eligible projects,
ranging from construction of spaces and other capital improvements to
using intelligent transportation systems (ITS) technology to increase
information on the availability of both public and private commercial
vehicle parking spaces. Please note that applications to the Truck
Parking Program with respect to ``Corridors of the Future'' may receive
priority in consideration and funding under the program.
    (ix) FTA's Bus Program. The Department may obligate all or part of
such sums available for obligation in its discretion under the Bus
Program in Fiscal Year 2008 to support eligible projects sponsored by
qualified jurisdictions. Under 49 U.S.C. 5309, the Administrator of
FTA, acting on behalf of the Secretary, may provide capital assistance
for the acquisition of buses and bus-related equipment or facilities.
Only capital projects that are eligible under the Bus Program and that
improve existing transit service or provide new transit service in a
corridor or area that is part of a congestion reduction demonstration
shall be eligible for funding pursuant to this Notice.
    Costs of a project eligible for funding under the Bus Program
include the acquisition of buses for fleet and service expansion, bus
maintenance and administrative facilities, transfer facilities, bus
malls, transportation centers, inter-modal terminals, park-and-ride
stations, acquisition of replacement vehicles, bus rebuilds, passenger
amenities such as passenger shelters and bus stop signs, accessory and
miscellaneous equipment such as mobile radio units, supervisory
vehicles, fare boxes, computers and shop and garage equipment.
Applicants must address FTA's standard requirements for an application
for Section 5309 capital program assistance found in FTA's Circular C
9300.1A ``Capital Program: Grant Application Instructions'' \9\ and
FTA's Circular C 5010.1C ``Grant Management Guidelines.'' \10\
---------------------------------------------------------------------------

    \9\ See http://www.fta.dot.gov/funding/grants/grants_financing_3557.html
.

    \10\ See http://www.fta.dot.gov/laws/circulars/leg_reg_4114.html
.

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

    (x) FTA's Small Starts Program. The Department may obligate all or
part of such sums available for obligation in its

discretion under the Small Starts Program in Fiscal Year 2008 to
support eligible projects sponsored by qualified jurisdictions. Under
49 U.S.C. 5309, the Administrator of FTA, acting on behalf of the
Secretary, may provide up to $75 million per project for qualifying
fixed guideway capital projects, including certain bus rapid transit
projects. Pursuant to its guidance on the Small Starts Program,\11\ FTA
will facilitate worthy projects that are part of comprehensive
congestion-reduction strategies, including strategies that incorporate
congestion pricing. In its evaluation of projects proposed for funding
under Small Starts pursuant to this Notice, an applicant's designation
as a qualified jurisdiction will be an ``other factor'' taken into
account by the FTA pursuant to 49 U.S.C. 5309(e)(4)(E).
---------------------------------------------------------------------------

    \11\ Please see the terms of the Small Starts program set forth
in the Guidance on Small Starts at http://a257.g.akamaitech.net/7/257/2422/01jan20071800/edocket.access.gpo.gov/2007/pdf/07-2774.pdf
.

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

    (xi) FTA's Alternatives Analysis Program. The Department may
obligate all or part of such sums available for obligation in its
discretion under the Alternatives Analysis Program in Fiscal Year 2008
to support eligible projects sponsored by qualified jurisdictions.
Under 49 U.S.C. 5339, the FTA Administrator, acting on behalf of the
Secretary, may fund projects that support technical work conducted
within an alternatives analysis, in which one of the alternatives is a
major transit capital investment. FTA will give priority to proposals
to develop and apply methods to estimate the time savings experienced
by highway users that result from transit investments.
    Applicants must address the standard requirements for an
application to the Alternatives Analysis Program found in notice
describing the Alternatives Analysis Program at http://a257.g.akamaitech.net/7/257/2422/01jan20071800/edocket.access.gpo.
 gov/

2007/pdf/E7-4830.pdf. The application procedures and deadlines provided
in this Notice supersede those set forth in the forgoing hyperlink.
    (xii) Other Assistance. Under the Department's Private Activity
Bond Program, the Department may allocate to qualified jurisdictions
authority to issue private activity bonds for qualified projects in
order to lower their cost of capital. As of the date of this Notice,
the Department may allocate up to $9.5 billion in private activity bond
authority not already allocated or applied for.
    Under the Transportation Infrastructure Finance and Innovation Act
(``TIFIA''), the Department may provide qualified jurisdictions direct
loans, loan guarantees, and standby lines of credit for qualified
projects. TIFIA allows for the support of approximately $10 billion in
credit assistance.
    The Department may provide qualified jurisdictions the authority to
institute tolls on portions of their Interstate systems\12\ and
expedite project delivery by waiving certain FHWA regulations (in
accordance with FHWA's Special Experimental Project (or ``SEP-15'')
program or as otherwise permitted by law), and placing key projects on
the Environmental Stewardship Executive Order,\13\ allowing for the
streamlining of some aspects of the environmental review process.
Finally, the Department may offer extensive technical expertise and
advice from world class engineers and economists.
---------------------------------------------------------------------------

    \12\ As enacted by SAFETEA-LU, the High Occupancy Vehicle
(``HOV'') Facilities Program (23 U.S.C. 166) allows States and
localities to convert HOV lanes to high Occupancy toll (``HOT'')
lanes which allow low-occupant vehicle users to pay for the chance
to travel on underutilized HOV lanes, shifting traffic from
congested regular lanes to HOV lanes, while maintaining free-flowing
travel speeds and vehicle throughput performance for all vehicles in
the HOV lanes. When operated in parallel with general purpose lanes,
HOT lanes offer drivers an option to pay for congestion-free
predictable trips when they need it the most, while improving the
performance of general purpose lanes. Consistent with 23 U.S.C. 166,
FTA has recently published proposed guidance that, once adopted as
final, would eliminate certain existing disincentives to
jurisdictions to convert their HOV lanes to HOT lanes. In particular
the proposed guidance describes the terms and conditions on which
FTA would classify HOV lanes that are converted to HOT lanes as
``fixed guideway miles'' for purposes of the transit funding
formulas administered by FTA. See ``Policy Statement on When High-
Occupancy Vehicle Lanes Converted to High-Occupancy/Toll Lanes Shall
Be Classified as Fixed Guideway Miles for FTA's Funding Formulas and
When HOT Lanes Shall Not Be Classified as Fixed Guideway Miles for
FTA's Funding Formulas'' (http://a257.g.akamaitech.net/7/257/2422/01jan20061800/edocket.access.gpo.gov/2006/pdf/E6-14796.pdf
).

    \13\ See Executive Order 13274: Environmental Stewardship and
Transportation Infrastructure Project Reviews (September 18, 2002)
at http://environment.fhwa.dot.gov/strmlng/eo091802.asp.

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C. Application Process

    Applications to become qualified jurisdictions must be submitted on
or before December 31, 2007 (with late-filed applications being
considered to the extent practical).
    The Department expects to sign agreements with qualified
jurisdictions, once designated, as soon as possible thereafter. The
Department expects implementation or pre-implementation efforts for the
proposed congestion reduction activities to commence shortly after an
agreement (or series of agreements) with the qualified jurisdiction is
signed.
    While the applicant for consideration as a qualified jurisdiction
must be a public body, signatories to an agreement concerning
congestion-reducing projects may include city and county governments,
metropolitan planning organizations, State transportation departments,
chambers of commerce, academic institutions, citizen advisory groups,
or other responsible organizations that seek to resolve major
congestion problems (any of whom may apply to become a qualified
jurisdiction).
    The Department shall deem a single application filed pursuant to
this Notice to be an application properly filed with each of the
Funding Programs. Separate applications to specific Funding Programs
shall not be required.

D. Contents of Application

    An application to become a qualified jurisdiction should briefly
describe, with respect to the metropolitan area proposed, (i) why its
traffic congestion is severe, (ii) the local public's acknowledgement
of the problem, (iii) the readiness of the metropolitan area's
political leadership to solve the problem and (iv) a solution to
congestion that integrates innovative transit strategies, new
transportation technologies and direct highway pricing during congested
periods. In addition, an application should be responsive to the
specifications and criteria set forth below. The Department recognizes
that information provided in an application to become a qualified
jurisdiction may be preliminary and incomplete. The Department, in its
discretion, may ask certain applicants to supplement the data in their
applications to the extent practical.
    (i) Length of Applications: An application should not exceed 40
pages in length, including both the proposal details and appendix
materials. Appendix materials may include maps of roadways and other
affected facilities (such as bridges and parallel routes) and maps of
BRT routes and other transit services or facilities that are directly
involved.
    (ii) Participating Parties: An application should provide a
preliminary, non-binding list of the parties likely to participate in
the agreement between a qualified jurisdiction and the Department.
    (iii) Comprehensive Congestion Reduction Strategy: An application
should generally describe the metropolitan area's proposed
comprehensive congestion reduction strategy, and explain how different
parts of that strategy, if any, would interact to reduce congestion.

    (iv) Congestion Pricing Measures and Affected Areas: An application
should describe the role pricing would play in the congestion reduction
strategy. To the extent practical, an application should indicate, in
specific terms, how traffic would be affected, what areas or routes
would be priced, how congestion prices would be determined, and which
vehicle categories would be affected (e.g., single occupant vehicles or
all vehicles).
    (v) Transit Services: An application should describe transit
services, including BRT and other commuter transit services that are to
be provided or supplemented, and the expected impacts of the expanded
transit services on congestion. The application should also describe
transit fare pricing policies to be adopted with the objective of
increasing traveler throughput during peak traffic periods, while
avoiding excessive congestion in the transit system.
    (vi) Use of Technology: An application should clearly indicate the
extent to which a locality plans to operationally test innovative
technology in achieving its congestion reduction targets.
    (vii) Expedited Project Completion: An application should indicate
any major transportation projects or project components that are sought
to be expedited through an agreement with the Department. The
application should also indicate the expected effects on congestion
from early completion of these projects.
    (viii) Travelers Affected Daily: An application should indicate the
estimated number of daily travelers that will be directly affected by
priced facilities and by other measures expected to be adopted by the
qualified jurisdiction. This should include the estimated number of
persons (vehicles) that will pay congestion charges, as well as the
likely number diverted to other travel times, routes, or other
transportation services, such as transit.
    (ix) Research, Planning, and Experience To Date: An application
should indicate the prior work that participating parties (e.g., the
candidate city or other jurisdictions) have already done to reduce
congestion, including research, planning, and actual implementation of
congestion related activities in the metropolitan area.
    (x) Other Time-Frame Considerations: An application should indicate
the dates during which applicants expect to conduct congestion
reduction activities (e.g., a six-month trial from June 30, 2008 until
December 31, 2008). If the applicant expects the activities to continue
indefinitely, the application should indicate this fact. Similarly, if
the pricing activity is adopted on a temporary, experimental basis and
the applicant expects it to be voted on by citizens of the
jurisdictions participating in an agreement with the Department or
otherwise considered for continuation, the application should provide
this information.
    (xi) Funding Support: An application should indicate the estimated
cost to implement the overall congestion reduction strategy. An
application should also indicate the anticipated sources of those
funds, including the amount requested to be covered by Federal sources.
    (xii) Contact Information: An application should clearly indicate
contact information, including name, organization, address, phone
number, and e-mail address. The Department will use this information to
inform parties of the Department's decision regarding selection of
interested parties, as well as to contact parties in the event that the
Department needs additional information about an application.

E. Evaluation Criteria

    The Department will review and consider applications upon receipt,
and will consider a variety of factors in reviewing applications
seeking funding, including:
    (i) The extent to which the congestion reduction plan is reasonably
projected to reduce congestion from current levels on major highways
and arterial facilities within the demonstration area, as measured by
projected travel speeds, ``levels of service'' or other objective
measures of performance during the hours when the congestion reduction
demonstration is in effect;
    (ii) The extent to which the congestion reduction plan is
reasonably projected to enable improvements in transit service on major
highways and arterial facilities within the demonstration area, as
measured by projected reductions from current levels in scheduled
running times or intervals between departures or other objective
measures of performance during the hours when the congestion reduction
plan is in effect;
    (iii) The extent to which the congestion reduction plan
demonstrates innovative and potentially far-reaching technology
applications;
    (iv) The project's national demonstration value; and
    (v) The technical feasibility and political probability of the
project being implemented in the near term.
    The Department reserves the right to solicit candidates for
agreements described herein by means other than this Notice. The
Department expects to implement the procedures and criteria set forth
in this Notice; however, such procedures and criteria shall not be
binding on the Department.

    Issued in Washington, DC on November 5, 2007.
D.J. Gribbin,
General Counsel, U.S. Department of Transportation.
 [FR Doc. E7-22117 Filed 11-9-07; 8:45 am]

BILLING CODE 4910-9X-P


[Federal Register Volume 82, Number 229 (Thursday, November 30, 2017)]
[Notices]
[Pages 56824-56826]
[FR Doc No: 2017-25822]

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPPT-2016-0675; FRL-9968-41]

TSCA Reporting and Recordkeeping Requirements; Standards for
Small Manufacturers and Processors; Final Determination

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: On December 15, 2016, EPA issued a notice in the Federal
Register requesting public comment on whether revision to the current
size standards for small manufacturers and processors, which are used
in connection with reporting regulations under the Toxic Substances
Control Act (TSCA) section 8(a), is warranted. This document describes
EPA's final determination that revision to the current size standards
is warranted.

FOR FURTHER INFORMATION CONTACT: For technical information contact:
Lynne Blake-Hedges, Chemistry, Economics, and Sustainable Strategies
Division (7406M), Office of Pollution Prevention and Toxics,
Environmental Protection Agency, 1200 Pennsylvania Ave. NW.,
Washington, DC 20460-0001; telephone number:<PHONE_NUMBER>; email
address: [email protected].
    For general information contact: The TSCA-Hotline, ABVI-Goodwill,
422 South Clinton Ave., Rochester, NY 14620; telephone number: (202)
554-1404; email address: [email protected].

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this action apply to me?

    You may be potentially affected by this action if you manufacture
or process chemical substances or mixtures. The following list of North
American Industrial Classification System (NAICS) codes is not intended
to be exhaustive, but rather provides a guide to help readers determine
whether this document applies to them. Potentially affected entities
may include:
     Basic Chemical Manufacturers (NAICS code 3251);
     Resin, Synthetic Rubber, and Artificial Synthetic Fibers
and Filament Manufacturers (NAICS code 3252);
     Pesticide, Fertilizer, and Other Agricultural Chemical
Manufacturers (NAICS code 3253);
     Paint, Coating, and Adhesive Manufacturers (NAICS code
3255);
     Other Chemical Product and Preparation Manufacturers
(NAICS code 3259); and
     Petroleum Refineries (NAICS code 32411).

B. How can I get copies of this document and other related information?

    The docket for this action, identified by docket identification
(ID) number EPA-HQ-OPPT-2016-0675, is available at http://www.regulations.gov or at the Office of Pollution Prevention and Toxics
Docket (OPPT Docket), Environmental Protection Agency Docket Center
(EPA/DC), West William Jefferson Clinton Bldg., Rm. 3334, 1301
Constitution Ave. NW., Washington, DC. The Public Reading Room is open
from 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal
holidays. The telephone number for the Public Reading Room is (202)
566-1744, and the telephone number for the OPPT Docket is (202) 566-
0280. Please review the visitor instructions and additional information
about the docket available at http://www.epa.gov/dockets.

II. What action is the agency taking?

    On June 22, 2016, President Obama signed into law the Frank R.
Lautenberg Chemical Safety for the 21st Century Act which amends the
Toxic Substance Control Act (TSCA), the nation's primary chemicals
management law. A summary of the new law is available at https://www.epa.gov/assessing-and-managing-chemicals-under-tsca/frank-r-lautenberg-chemical-safety-21st-century-act. This particular action
involves revised TSCA section 8(a)(3)(C), which requires EPA, after
consultation with the Administrator of the Small Business
Administration, to review the adequacy of the standards for determining
which manufacturers and processors qualify as small manufacturers and
processors for purposes of TSCA sections 8(a)(1) and 8(a)(3). (Note
that under TSCA section 3(9), manufacture includes import.) TSCA
furthermore requires that (after consulting with the Small Business
Administration and providing public notice and an opportunity for
comment) EPA determine whether revision of the standards is warranted.
For the reasons described below, EPA determines that revision of the
standards is warranted.
    In the 1980s, EPA issued standards that are used in identifying
which businesses qualify as small manufacturers and processors for
purposes of the reporting and recordkeeping rules issued under TSCA
section 8(a). Under TSCA section 8(a)(1), small manufacturers and
processors are generally exempt from section 8(a) reporting
requirements, except in limited cases set forth in TSCA section
8(a)(3).
    In 1982, EPA finalized standards for determining which
manufacturers of a reportable chemical substance qualify as small
manufacturers for purposes of the section 8(a) Preliminary Assessment
Information Reporting (PAIR) rules, codified in 40 CFR part 712,
subpart B. The small manufacturer standard for PAIR rules is found at
40 CFR 712.25(c).
    In 1988, EPA established general small manufacturer standards for
use in other rules issued under TSCA section 8(a) (40 CFR 704.3). For
example, these are the standards that now apply to the Chemical Data
Reporting (CDR) rule (40 CFR part 711). The general standards are
somewhat different from the earlier standards that are codified for use
in the PAIR rules. The general small manufacturer standards are as
follows:
    Small manufacturer or importer means a manufacturer or importer
that meets either of the following standards:
    1. First standard. A manufacturer or importer of a substance is
small if its total annual sales, when combined with those of its parent
company (if any), are less than $40 million. However, if the annual
production or importation volume of a particular substance at any
individual site owned or controlled by the manufacturer or importer is
greater than 45,400 kilograms (100,000 pounds), the manufacturer or
importer shall not qualify as small for purposes of reporting on the
production or importation of that substance at that site, unless the
manufacturer or importer qualifies as small under standard (2) of this
definition.
    2. Second standard. A manufacturer or importer of a substance is
small if its

total annual sales, when combined with those of its parent company (if
any), are less than $4 million, regardless of the quantity of
substances produced or imported by that manufacturer or importer.
    3. Inflation index. EPA shall make use of the Producer Price Index
for Chemicals and Allied Products, as compiled by the U.S. Bureau of
Labor Statistics, for purposes of determining the need to adjust the
total annual sales values and for determining new sales values when
adjustments are made. EPA may adjust the total annual sales values
whenever the Agency deems it necessary to do so, provided that the
Producer Price Index for Chemicals and Allied Products has changed more
than 20 percent since either the most recent previous change in sales
values or the date of promulgation of this rule, whichever is later.
EPA shall provide Federal Register notification when changing the total
annual sales values.
    Pursuant to authority under section 8(a)(3)(B), certain section
8(a) rules codify slight variations of the general small manufacturer
standards at 40 CFR 704.3. (See, e.g., 40 CFR 704.45). Other rules
issued under TSCA section 8(a) establish (for use in a particular rule)
analogous standards for small processors (See, e.g., 40 CFR 704.33).
    As an initial step in evaluating whether a change in these current
size standards are warranted, EPA reviewed the change in the Producer
Price Index (PPI) for Chemicals and Allied Products between 1988 (the
year the general size standards at 40 CFR 704.3 were last revised) and
2015 (the most recent year of PPI data available) (Ref. 1). EPA found
that the PPI has changed by 129 percent, far exceeding the 20 percent
inflation index specified as a level above which EPA may adjust annual
sales levels in the current standard if deemed necessary. This change
to the PPI is pertinent for both the $4 million annual sales standard
and the $40 million threshold used in the combined sales and production
standard. Furthermore, among the more than 500 revenue-based size
standards set by the Small Business Administration (SBA), the lowest is
$5.5 million, and more than 75% of those standards are in excess of
$7.5 million. Some revenue-based standards are as high as $38.5
million. Thus, EPA's existing $4 million annual sales standard is an
outlier at the low end of this range. Along the same lines, the sales-
only size standard EPA recently adopted for the TSCA section 8(a)
nanoscale reporting rule is $11 million, significantly larger than $4
million. Because of the magnitude of the increase in the PPI since the
last revision of the size standards and because the current annual
sales standard is comparatively low given current revenue-based size
standards developed by SBA, EPA preliminarily determined that a
revision to currently codified size standards is warranted.
    On December 15, 2016, EPA published its preliminary determination
and requested public comment on the adequacy of the current standards
and whether revision of the standards is warranted. In addition, EPA
consulted with the SBA and received feedback on the consultation from
SBA on April 5, 2017. SBA's consultation feedback recommended that EPA
``apply a comprehensive approach that not only evaluates inflation but
also examines other important factors, such as the characteristics of
firms and industries associated with manufacturing or importation of
chemical substances and percentage of firms impacted by the rules, to
determine whether or not a revision to the current size standards is
warranted.''
    EPA reopened the public comment period on May 9, 2017 to give the
public an opportunity to review SBA's consultation feedback to inform
their comments on EPA's preliminary determination. On May 9, 2017,
EPA's preliminary finding and its basis remained the same as in the
December 15, 2016 publication in the Federal Register.
    EPA's decision not to consider a more comprehensive range of
factors as recommended in SBA's consultation feedback before taking the
current action is appropriate because the current action is limited to
determining whether ``revision of the standards'' is warranted or not.
See TSCA section 8(a)(3)(C)(ii). (The set of size standards covered by
this determination are those that EPA has issued under TSCA section
8(a)(3)(B), pertinent to information collection under TSCA section
8(a).) EPA found that the PPI index changed by a percentage far
exceeding the 20 percent inflation index. EPA had previously specified
20 percent as a level above which EPA may adjust annual sales levels in
the current standard if deemed necessary. This change in the PPI index
(along with the observation that the current annual sales standard is
comparatively low given current revenue-based size standards developed
by SBA) is a sufficient basis to determine that some revision of the
standards is warranted, even if there are other factors that could have
supported the same conclusion. EPA notes that the SBA's Office of
Advocacy substantively agreed with EPA's preliminary determination
(that a revision to the current size standards is warranted) even
though it requested EPA to consider additional factors in reaching that
conclusion.
    EPA received a number of comments on its preliminary determination.
Most commenters agreed with EPA's preliminary determination that an
update is warranted. SBA submitted comments that argued that EPA should
have considered more than the second (i.e., the sales-only) standard
when making a final determination, such as whether the standard is
structured appropriately. This comment is similar to the SBA's
recommendation in its consultation feedback that EPA evaluate a broader
set of factors related to firm and industry characteristics and
percentage of firms impacted by section 8 rules to determine whether or
not a revision to the standards is necessary. However, as previously
noted, the change in the PPI index (along with the comparative analysis
of the current annual sales standard) is a sufficient basis to
determine (even if other factors could have supported the same
conclusion) that some revision of the standards for small manufacturers
and processors is warranted, for both the sales-only and the sales plus
production standards.
    Two commenters questioned whether a revision to the standards is
warranted. One of these commenters argued that the standards should not
be changed, based on the serious nature of unspecified chemicals of
concern. The second commenter argued that a revision to the standards
that would result in classifying more manufacturers or processors as
small is not warranted because states need to have complete information
about chemical use, including volume, location, and toxicity, in order
to effectively respond to emergencies and to prioritize resources to
address concerns among various chemicals.
    EPA does not agree that either argument justifies a determination
that revision of the standards is not warranted. The first commenter
did not explain how chemical risks would be exacerbated by updating the
status quo of small manufacturer standards. With regard to the second
comment, the outcome of the rulemaking (i.e., whether it would result
in exempting more firms from reporting than under the current
standards) cannot be known until the rulemaking is complete. Although
revising the size standards for inflation could be presumed to increase
the number of exempt firms, the second commenter did not explain how
such increase would necessarily translate into a loss of information
necessary for

states to effectively respond to emergencies and prioritize resources.
With respect to the need of states to have complete information about
the toxicity of particular chemical substances, EPA notes that the size
standards at issue in this action only relate to the collection of
information under TSCA section 8(a). The primary information collection
under TSCA section 8(a) is the Chemical Data Reporting rule, 40 CFR
part 711, which collects exposure-related data rather than hazard data.
In any event, although the exemption of small businesses from reporting
necessarily reduces the amount of chemical information EPA collects,
Congress nonetheless decided to provide for an exemption and directed
EPA to determine the need for revision. As explained above, EPA
believes the currently promulgated standards are clearly outdated with
respect to the current understanding of what qualifies a business as
small. EPA has not yet proposed any revisions to the size standards;
any changes would be established through future notice and comment
rulemaking. At that time, public comments regarding the merits of any
proposed revisions would be sought by EPA and subsequently addressed.
    Several commenters also provided their opinions on how the
standards should be specifically revised or explained why specific
parts of the standards ought to be maintained. For example, SBA
commented that, when developing standards, EPA should consider a broad
range of factors that may potentially be relevant in the context of
TSCA reporting. These factors include barriers to entry, start-up and
expansion costs, capital versus labor intensiveness of industries,
average firm size (employment and revenue), growth trends, and
technological factors. Multiple commenters agreed with SBA's
recommendations. Additionally, one commenter argued that the combined
sales and production standard should be revised by lowering its
production threshold and not changing its $40 million sales threshold.
However, the scope of this action is limited to a general determination
as to whether some revision to the TSCA small manufacturer and
processor standards is warranted. More particular issues (i.e.,
relating to how the standards ought to be revised) will be addressed in
a subsequent rulemaking and are beyond the scope of this action.
Although EPA has no obligation to respond to the suggestions for
specific revisions submitted as comments on this action, EPA intends to
consider these comments as it develops its rulemaking proposal. Members
of the public who wish to maintain previously submitted comments or who
wish to submit new comments may do so following the publication of
EPA's proposal in the Federal Register. EPA will address such comments
prior to finalizing any changes to the TSCA size standards.
    EPA's preliminary determination that a revision to size standards
was warranted did not include the size standard for nanoscale materials
found at 40 CFR 704.20. See 81 FR 90842 (determination was only with
respect to currently codified size standards as of December 15, 2016).
EPA promulgated the size standards at 40 CFR 704.20 on January 12,
2017, along with the other provisions of EPA's reporting and
recordkeeping rule for nanoscale materials. Concurrent with
promulgating the size standards at 40 CFR 704.20, EPA indicated that it
would consider the adequacy of the size standards at 40 CFR 704.20 in
the course of finalizing this determination under TSCA section
8(a)(3)(C). 82 FR 3650. At this point, EPA has not made a determination
as to whether the size standards in the nanotechnology rule warrant
revision. EPA will further evaluate the need for any revision as part
of the rulemaking to revise the standards identified in this final
determination.
    Based on EPA's preliminary determination, a review of the comments
on the preliminary determination, and the feedback from consultation
from SBA, EPA is now making a final determination under TSCA section
8(a)(3)(C)(ii) that revision to the TSCA section 8(a) size standards
for manufacturers and processors is warranted.

III. 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.
    U.S. Bureau of Labor Statistics. ``Producer Price Index, Series
WPU06, Chemicals and Allied Products, 1933-2015''. Retrieved November
14, 2016 from http://data.bls.gov/cgi-bin/srgatet.

    Authority:  15 U.S.C. 2607(a).

    Dated: November 21, 2017.
Charlotte Bertrand,
Acting Principal Deputy Assistant Administrator, Office of Chemical
Safety and Pollution Prevention.
[FR Doc. 2017-25822 Filed 11-29-17; 8:45 am]
 BILLING CODE 6560-50-P