[Federal Register Volume 76, Number 119 (Tuesday, June 21, 2011)]
[Proposed Rules]
[Pages 36019-36027]
[FR Doc No: 2011-15346]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 600, 610, and 680

[Docket No. FDA-2011-N-0080]

Amendments to Sterility Test Requirements for Biological Products

AGENCY: Food and Drug Administration, HHS.

ACTION: Proposed rule.

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SUMMARY: The Food and Drug Administration (FDA) proposes to amend the
sterility test requirements for biological products. This proposed rule
is intended to provide manufacturers of biological products greater
flexibility and to encourage use of the most appropriate and state-of-
the-art test methods for assuring the safety of biological products. We
are taking this action as part of our continuing effort to review and,
as necessary, update the biologics regulations.

DATES: Submit either electronic or written comments on this proposed
rule by September 19, 2011. See section X of this document for the
proposed effective date of any final rule that may publish based on
this proposal.

ADDRESSES: You may submit comments, identified by Docket No. FDA-2011-
N-0080, by any of the following methods:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: http://www.regulations.gov.
Follow the instructions for submitting comments.

Written Submissions

    Submit written submissions in the following ways:
     FAX:<PHONE_NUMBER>.
     Mail/Hand delivery/Courier (For paper, disk, or CD-ROM
submissions): Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
    Instructions: All submissions received must include the Agency name
and Docket No. FDA-2011-0080 for this rulemaking. All comments received
may be posted without change to http://www.regulations.gov, including
any personal information provided. For additional information on
submitting comments, see the ``Comments'' heading of the SUPPLEMENTARY
INFORMATION section of this document.
    Docket: For access to the docket to read background documents or
comments received, go to http://www.regulations.gov and insert the
docket number, found in brackets in the heading of this document, into
the ``Search'' box and follow the prompts and/or go to the Division of
Dockets Management, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Paul E. Levine, Jr., Center for
Biologics Evaluation and Research (HFM-17), Food and Drug
Administration, 1401 Rockville Pike, Suite 200N, Rockville, MD 20852-
1448,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    Any product that purports to be sterile should be free of viable
contaminating microorganisms to assure product safety (Sec.  600.3(q)
(21 CFR 600.3(q)). Absolute sterility of a lot cannot be practically
demonstrated without complete destruction of every finished article in
that lot (United States Pharmacopeia (USP) Chapter 1211). Therefore,
sterility assurance is accomplished primarily by validation of the
sterilization process or of the aseptic processing procedures under
current good manufacturing practice (CGMP), and is supported by
sterility testing using validated and verified test methods. (See e.g.,
USP Chapter 71>, European Pharmacopeia 2.6.2.)
    In the Federal Register of November 20, 1973 (38 FR 32048), we
reorganized and republished the biologics regulations, which included
regulations governing sterility testing, as title 21 of the Code of
Federal Regulations (CFR), subchapter F, parts 600 through 680 (21 CFR
parts 600 through 680). Section 610.12 currently requires manufacturers
to perform sterility tests for both bulk and final container material
of most biological products \1\ for the detection of

viable contaminating microorganisms (e.g., bacteria, molds, and/or
yeasts).
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    \1\ Sterility tests are not currently required to be performed
for Whole Blood, Cryoprecipitated Antihemophilic Factor (AHF),
Platelets, Red Blood Cells, Plasma, Source Plasma, Smallpox Vaccine,
Reagent Red Blood Cells, Anti-Human Globulin, or Blood Grouping
Reagents; or in cases where the Director of the Center for Biologics
Evaluation and Research (CBER) or the Center for Drug Evaluation and
Research (CDER), as appropriate, determines that the mode of
administration, method of preparation, or special nature of the
product precludes or does not require a sterility test or that the
sterility of the lot is not necessary to assure the safety, purity,
and potency of the product. (See 21 CFR 610.12(g)(4).)
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    Over the years, FDA has amended the biologics regulations, as
necessary, to clarify and update the sterility test requirements. On
March 11, 1976 (41 FR 10427) and March 2, 1979 (44 FR 11754), we
updated Sec.  610.12 to clarify the procedures for repeat testing. On
April 18, 1984 (49 FR 15186), we amended Sec.  610.12 by removing and
reserving paragraph (g)(3) previously entitled Different Tests Equal or
Superior and by adding Sec.  610.9 entitled Equivalent methods and
processes to provide manufacturers of licensed biological products the
flexibility to use alternate test methods or manufacturing processes
that provide assurances of safety, purity, potency, and effectiveness
equal or greater than those provided by the methods or processes
specified in the regulations under parts 610 through 680. On December
15, 1986 (51 FR 44903), we clarified and updated certain requirements
for sterility testing to ensure the reliability of the growth-promoting
qualities of the sterility test culture media and to provide greater
consistency with the requirements of USP Chapter XXI. Finally, on
September 15, 1997 (62 FR 48174), we incorporated by reference the 1995
ed. of the USP concerning the procedures for the membrane filtration
test method.
    Section 610.12 currently requires that the sterility of most
licensed biological products \2\ be demonstrated through the
performance of tests prescribed in Sec.  610.12(a) and (b).
Specifically, Sec.  610.12 requires that the sterility of each lot of
each product, with the exception of certain products,\3\ be
demonstrated by the performance of prescribed sterility tests for both
bulk and final container material, unless different sterility tests are
prescribed in the license (see Sec.  610.12(g)(1)) or the manufacturer
submits adequate data \4\ establishing that the mode of administration,
the method of preparation, or the special nature of the product
precludes or does not require a sterility test, or that the sterility
of the lot is not necessary to assure the safety, purity, and potency
of the product (Sec.  610.12(g)(4)(ii)).
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    \2\ See list of exemptions in Sec.  610.12(g)(4).
    \3\ Whole Blood, Cryoprecipitated AHF, Platelets, Red Blood
Cells, Plasma, Source Plasma, Smallpox Vaccine, Reagent Red Blood
Cells, Anti-Human Globulin, or Blood Grouping Reagents (Sec.
610.12(g)(4)(i)).
    \4\ The Director of CBER or CDER, as appropriate, will determine
the adequacy of the data (Sec.  610.12(g)(4)(ii)).
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    The regulation, under Sec.  610.12, also specifies the test method
and culture media to be used. For instance, the prescribed sterility
test methods rely upon culture media (either Fluid Thioglycollate
Medium or Soybean-Casein Digest Medium) to detect growth of
microorganisms (Sec.  610.12(a)(1) and (a)(2)). Moreover, Sec.  610.12
specifies criteria, such as incubation conditions (time and
temperature) to be used during testing, suitable test organisms for the
evaluation of the growth-promoting qualities of the culture media,
storage and maintenance of test organism cultures, and storage and
condition of media.
    Manufacturers of innovative products, such as cell and gene therapy
products, as well as manufacturers of currently approved products, may
benefit from sterility test methods with rapid and advanced detection
capabilities. Advances in technology in recent years have allowed the
development of new sterility test methods that yield accurate and
reliable test results in less time and with less operator intervention
than the currently prescribed methods. Some examples of novel methods
with the potential to detect viable contaminating microorganisms
include the Adenosine Triphosphate (ATP) bioluminescence,
chemiluminescence, and carbon dioxide head space measurement.
    We are proposing to amend Sec.  610.12 to promote improvement and
innovation in the development of sterility test methods, to address the
challenges of novel products that may be introduced to the market in
the future, and to potentially enhance sterility testing of currently
approved products. This proposed revision would provide manufacturers
the flexibility to take advantage of modern methods as they become
available, provided that these methods meet certain criteria.

II. Highlights of This Proposed Rule

    We are proposing to amend the sterility test requirements for
biological products to provide manufacturers with greater flexibility
to encourage use of the most appropriate and state-of-the-art test
methods. The most significant proposed changes include the following:
     Elimination of specified sterility test methods, culture
media formulae (or formulations), and culture media test requirements;
     Elimination of specified membrane filtration procedure
requirement for certain products;
     Elimination of specified sterility test requirements for
most bulk material; \5\
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    \5\ See section III.A of this document for a detailed discussion
of when sterility testing of bulk material may be necessary and
appropriate.
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     Modification of the repeat sterility test requirements, so
that repeat tests would occur only once for each lot. These tests would
be limited to situations when the quality control unit conclusively
determines, after conducting an investigation upon detection of viable
microbial contamination during the initial test of the lot, that the
contamination is the result of laboratory error or faulty materials
used in conducting the sterility test;
     Replacement of the storage and maintenance requirements
for cultures of test organisms used to determine the ``growth-promoting
qualities'' of culture media with: (1) Validation requirements
specifying that any sterility test used is able to consistently detect
the presence of viable contaminating microorganisms and (2)
verification of ``growth-promoting properties'' \6\ or microorganism-
detection capabilities of test and test components;
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    \6\ We are proposing to refer to ``growth-promoting properties''
rather than ``growth-promoting qualities'' as we believe ``growth-
promoting properties'' may reflect more accurate and current
terminology. However, we invite comments on which term is most
appropriate.
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     Replacement of the sample size or amount requirement with
a requirement that the sample be appropriate to the material being
tested;
     Replacement of the Interpretation of test results
paragraph under Sec.  610.12(c) with a requirement that manufacturers
establish, implement, and follow written procedures for sterility
testing that describe, at a minimum, the test method used, the method
of sampling, and the written specifications for acceptance or rejection
of each lot; and
     Simplification of the Exceptions paragraph under Sec.
610.12(c).

III. Description of This Proposed Rule

    This proposed rule is intended to promote improvement and
innovation in the development of sterility test methods by allowing
manufacturers flexibility needed for sterility testing of some novel
products that may be introduced to the market, to enhance sterility
testing of currently approved products, and to encourage manufacturers
to benefit from scientific and technological advances in sterility test
methods as they become available.

A. When is sterility testing required?

    Currently, sterility testing must be performed, with certain
limited

exceptions, on both bulk and final container material for each lot of
each biological product prior to release of that lot (Sec. Sec.  610.1
and 610.12). A lot is defined as that quantity of uniform material
identified by the manufacturer as having been thoroughly mixed in a
single vessel (Sec.  600.3(x)).
    We propose to eliminate the sterility test requirement for most
bulk materials. We have determined that, in most cases, for purposes of
sterility testing, the most appropriate test material is the final
container material. We recognize that, due to the nature of some
biological products, testing the final container material may not
always be feasible or appropriate. Thus, proposed Sec.  610.12 would
require that prior to release, manufacturers of biological products
must perform sterility testing of each lot of each biological product's
final container material or other material (e.g., bulk material or
active pharmaceutical ingredient (API), in-process material, stock
concentrate material) as appropriate and as approved in the biologics
license application (BLA) or BLA supplement. For example, certain
allergenic and cell and gene therapy products may need to be tested for
sterility at an in-process stage or some other stage of the
manufacturing process (e.g., intermediate, API, bulk drug substance)
instead of the final container material, because the final container
material may interfere with the sterility test. Likewise, some cell
therapy products and cell-based gene therapy products may need to be
tested for sterility at an in-process stage or some other stage of
manufacturing process because low production volumes may result in an
insufficient final container material sample for sterility testing or a
short product shelf-life may necessitate administration of the final
product to a patient before sterility test results on the final
container material are available. If it is determined that sterility
testing needs to be performed on material other than the final product,
due to the nature of the final product, we would expect the
manufacturer, in its BLA or BLA supplement, to: (1) Describe the
details of the sterility test method, including the procedure for
testing the alternate material instead of the final container material
and (2) provide the scientific rationale for selecting the specific
test material.
    If this proposed rule is finalized, a manufacturer who desires to
utilize an alternate sterility test method other than the one approved
in its BLA must submit a BLA supplement in accordance with Sec.
601.12(b).

B. What are the sterility test requirements?

1. Test Methods
    Currently, Sec.  610.12(a), (b), and (e) prescribe the culture-
based test method to be used for sterility testing, including the
acceptable culture media (either Fluid Thioglycollate Medium or
Soybean-Casein Digest Medium) and incubation conditions (time and
temperature) to be used during testing, with exceptions provided in
Sec.  610.12(g). In addition, Sec.  610.12(f) provides that a membrane
filtration test method, set forth in (USP 23d revision, 1995), may be
used to test bulk and final container materials or products containing
oil products in water-insoluble ointments. We propose to eliminate
references to specific test methods and culture media for sterility
testing, and instead require that the sterility test be appropriate to
the material being tested such that the material does not interfere
with or otherwise hinder the test. We believe that this revision
recognizes current practices and provides manufacturers the flexibility
to take advantage of suitable modern sterility test methods and keep
pace with advances in science and technology. Because we are proposing
to expand potentially acceptable sterility test methods to include non-
culture-based methods in addition to culture-based methods, we also
propose to remove the definition of a lot of culture medium currently
defined in Sec.  610.12(e)(2)(i) as ``* * * that quantity of uniform
material identified as having been thoroughly mixed in a single vessel,
dispensed into a group of vessels of the same composition and design,
sterilized in a single autoclave run, and identified in a manner to
distinguish one lot from another. * * *'' Although we still consider
this definition to apply, we believe that this concept is captured by
the definition of ``lot'' in Sec.  600.3(x). This change also reflects
our recognition that prepared culture media may be purchased, in which
case a lot may be predetermined by the vendor.
    Section 610.12(e)(2)(i) currently provides an exception to the
growth-promoting test requirements for dehydrated culture media
provided that the manufacturer has an approved validation program for
autoclaves used to sterilize these media and the manufacturer has
received approval for this practice from the Director of CBER or CDER,
as appropriate. We propose to eliminate this exception. Proposed Sec.
610.12(h)(2) provides that all manufacturers seeking an exemption from
the sterility test requirements must submit, in their BLA or BLA
supplement, data that adequately establish that the route of
administration, the method of preparation, or any other aspect of the
product precludes or does not necessitate a sterility test.
    Additionally, current Sec.  610.12(e)(2)(ii) stipulates the test
organisms, strains, characteristics, identity, and verification to be
used. We propose to eliminate the requirement to test culture media
with specific test organisms and to eliminate the requirement regarding
the number of organisms that must be used to demonstrate the growth-
promoting qualities of the culture media. This flexibility would allow
manufacturers to use sterility test methods that are either culture-
based or non-culture-based, which may necessitate different
verification activities. Thus, instead of specifying the number and
type of test organisms, proposed Sec.  610.12(b) would require the
following: (1) Use of a sterility test method that is appropriate to
the material being tested such that the material does not interfere
with or otherwise hinder the test; (2) validation studies to
demonstrate that the sterility test method used is capable of
consistently detecting the presence of viable contaminating
microorganisms; and (3) verification that the sterility test method and
test components used can detect the presence of viable contaminating
microorganisms.
    Due to the variety of currently available and potential future
sterility test methods, we propose to eliminate specified incubation
conditions (time and temperature) and visual examination requirements
currently prescribed in Sec.  610.12. Because we propose to allow any
validated sterility test method that is appropriate to the material
being tested, rather than specifying the test and the media used, we
also propose to eliminate the Fluid Thioglycollate Medium incubation
temperatures prescribed in Sec.  610.12(a)(1)(ii) for the final
container material containing a mercurial preservative.
2. Validation
    The International Conference on Harmonisation (ICH) Q2(R1)
``Validation of Analytical Procedures: Text and Methodology'' dated
November 2005, states that ``[t]he objective of validation of an
analytical procedure is to demonstrate that it is suitable for its
intended purpose.'' \7\

Similarly, USP General Chapter 1223, ``Validation of Alternative
Microbiological Methods,'' states: ``Validation of a microbiological
method is the process by which it is experimentally established that
the performance characteristics of the method meet the requirements for
the intended application.'' For sterility testing, this means that the
test can consistently detect the presence of viable contaminating
microorganisms.
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    \7\ This text was previously named ``Text on Validation of
Analytical Procedures'' (Q2A) (approved by the Steering Committee in
October 1994). An accompanying ``Guideline on Validation of
Analytical Procedures: Methodology'' (Q2B) was subsequently
developed and approved by the Steering Committee in November 1996.
The parent guideline is now renamed Q2(R1) as the Guideline Q2B on
Methodology has been incorporated into the parent guideline. See
http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Quality/Q2_R1/Step4/Q2_R1__Guideline.pdf.
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    We propose to eliminate the prescribed sterility test methods found
in current Sec.  610.12 and instead allow the use of sterility test
methods that are validated in accordance with established protocols, to
be capable of consistently detecting the presence of viable
contaminating microorganisms. If an established USP compendial
sterility test method is used, a manufacturer must verify that this
established method is suitable for application to the specific product;
however, FDA considers established USP compendial sterility test
methods to already have been validated using an established validation
protocol, so their accuracy, specificity, and reproducibility need not
be re-established to fulfill the proposed validation requirement. In
contrast, novel methods and any methods that deviate from the USP
compendial sterility test methods would require the detailed validation
discussed in the following paragraphs.
    Proposed Sec.  610.12 allows the use of a material sample that does
not interfere with or otherwise hinder the sterility test from
detecting viable contaminating microorganisms. This requirement is
crucial, because the material itself or substances added to the
material during formulation may make some sterility tests inappropriate
for use. A validated sterility test method is a critical element in
assuring the safety and quality of the product. USP General Chapter
1223, as well as the ICH Guideline for Industry (Text on Analytical
Procedures), provide general descriptions of typical validation
parameters, how they are determined, and which subset of each parameter
is required to demonstrate validity, based on the method's intended
use. Validation of each test method should be performed on a case-by-
case basis, to ensure that the parameters are appropriate for the
method's intended use. In the context of reviewing sterility test
methods as part of BLAs and BLA supplements, FDA may decide, as
appropriate, to encourage the use of the compendial method as a
benchmark or starting point for validation of novel methods and certain
other methods. FDA is specifically seeking comments on whether the
proposed requirements are sufficient to ensure adequate validation of
novel sterility test methods or whether additional criteria or guidance
is needed.
    It is important to consider validation principles, such as limit of
detection, specificity, ruggedness, and robustness, while developing
the validation protocol and performing validation studies. These terms
are defined as follows:
     The limit of detection reflects the lowest number of
microorganisms that can be detected by the method in a sample matrix.
This is necessary to define what is considered contaminated.
     Specificity is the ability of the test method to detect a
range of organisms necessary for the method to be suitable for its
intended use. This is demonstrated by challenging the sterility test
with a panel of relevant organisms in the sample matrix.
     Ruggedness is the degree of reproducibility of results
obtained by analysis of the same sample under a variety of normal test
conditions, such as different analysts, different instruments, and
different reagent lots.
     Robustness is the capacity of the test method to remain
unaffected by small, but deliberate variations in method parameters,
such as changes in reagent concentration or incubation temperatures.
    Under 21 CFR 211.160(b), laboratory controls must include the
establishment of scientifically sound and appropriate specifications,
standards, sampling plans, and test procedures designed to assure that
components, drug product containers, closures, in-process materials,
labeling, and drug products conform to appropriate standards of
identity, strength, quality, and purity. We consider such laboratory
controls to be needed for both culture-based and non-culture-based
sterility test methods. The manufacturer must establish and document
the test method's accuracy, sensitivity, specificity, and
reproducibility (Sec.  211.165(e) (21 CFR 211.165(e)), as specified in
the BLA or BLA supplement (Sec. Sec.  601.2 and 601.12). For sterility
tests, FDA believes that a validation protocol that would meet these
standards would, at a minimum, include samples of the material to be
marketed, and incorporate appropriate viable contaminating
microorganisms to demonstrate the sterility test's growth-promoting
properties or the method's detection system capabilities, depending on
the type of test method used. In addition, validation protocols for
culture-based methods should include both aerobic and anaerobic
microorganisms when selecting test organisms and include microorganisms
that grow at differing rates so that manufacturers can establish that
the test media are capable of supporting the growth of a wide range of
microorganisms.
    When utilizing culture-based methods, validation protocols should
require that challenge organisms be added directly to the product prior
to membrane filtration or direct inoculation. If this is not possible
due to inhibition by the product, then validation protocols should
require that the challenge organism be added to the final portion of
sterile diluent used to rinse the filter if a membrane filtration test
method is used, or directly to the media containing the product if a
direct inoculation test method is used. For non-culture-based methods,
the feasibility of identifying microorganisms from a contaminated
sample should be evaluated during validation. If a method does not have
the capability to identify microorganisms to the species level, the
validation protocol should require that an additional method for
species identification be utilized for investigation of detected
contaminants. The test organisms selected should reflect organisms that
could be found in the product, process, or manufacturing environment.
    The validation study design should contain the appropriate controls
to evaluate the product sample's potential to generate false positive
and false negative results. Validation of the sterility test should be
performed on all new products, and repeated whenever there are changes
in the test method that could potentially inhibit or enhance detection
of viable contaminating microorganisms.
3. Verification
    Verification is the confirmation that specified requirements have
been fulfilled as determined by examination and provision of objective
evidence. While validation of a sterility test method is the initial
process of demonstrating that the procedure is suitable to detect
viable contaminating microorganisms, verification occurs over the
lifetime of the sterility test method and is the process of confirming
that the sterility test and test components continue to be capable of
consistently detecting viable

contaminating microorganisms in the samples analyzed. This verification
activity may be necessary periodically or each time a sample is tested,
depending upon the test method used. We propose to require that the
sterility test and test components be verified, as appropriate, to
demonstrate that they can continue to consistently detect viable
contaminating microorganisms. (See section III.E.2 of this document for
a more detailed discussion of verification.)

C. What information is needed in written procedures for sterility
testing?

    We propose to replace the requirement for Interpretation of test
results in Sec.  610.12(c) with the requirement that manufacturers
establish, implement, and follow written procedures for sterility
testing. Written procedures are essential to ensure consistency in
sampling, testing, and interpretation of results, and to provide
prospective acceptance criteria for the sterility test. Written
procedures should include all steps to be followed in the sterility
test method for initial and repeat tests. Procedures should be detailed
and clear to eliminate ambiguity. Under the CGMP regulations,
manufacturers are required to document that a drug product
satisfactorily conforms to final specifications for the drug product
(Sec.  211.165(a)). As such, scientifically sound and appropriate
specifications, standards, sampling plans, and test procedures must be
designed and written to ensure that materials conform to appropriate
standards of sterility; and written procedures must include a
description of the sampling method and the number of units per batch to
be tested. (See Sec.  211.165(c).)
    Proposed Sec.  610.12 allows the use of either culture-based or
non-culture-based sterility test methods to evaluate material for
sterility. There are marked differences between culture-based and non-
culture-based sterility tests. Proposed Sec.  610.12(c) provides the
following minimum critical considerations that must be included in
written procedures for both culture-based and non-culture-based
sterility tests:
     The sterility test method to be used;
     The method of sampling, including the number, volume, and
size of articles to be tested;
     Written specifications for the acceptance or rejection of
each lot; and
     A statement of any other function critical to the
particular sterility test method to ensure consistent and accurate
results.
    For culture-based sterility test methods, FDA believes the minimum
critical considerations include the composition of media, growth
promotion test requirements, and incubation conditions (time and
temperature). For non-culture-based sterility test methods, the Agency
believes critical considerations include the composition of test
components, test parameters, and the controls used to verify the test
method's ability to consistently detect the presence of viable
contaminating microorganisms.

D. What is an appropriate sample for sterility testing?

    Selection of an appropriate sample of a lot is critical for
purposes of sterility testing. Current Sec.  610.12(d) prescribes the
number of samples for testing bulk and final container material. Due to
the variety of products covered under Sec.  610.12, including
innovative products that may be introduced to the market in the future,
such as cell and gene therapy products, we propose to eliminate the
sample number requirement and instead require that the sample be
appropriate to the material being tested. In selecting an appropriate
sample size, proposed Sec.  610.12(d) requires that the following
minimal criteria be considered:
     The size or volume of the final product lot. For example,
a final product lot size of 100,000 units would necessitate a greater
number of samples to be evaluated than a final product lot size of
5,000 units;
     The duration of manufacturing of the drug product.\8\ For
example, samples should be taken at different points of manufacture,
which, at a minimum should include the beginning, middle, and end of
manufacturing, in an effort to provide evidence of sterility of the
drug product throughout the duration of the manufacturing process;
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    \8\ See 21 CFR 210.3(b)(4) for definition of ``drug product.''
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     The final container configuration and size. We believe
this will ensure appropriate representation of the lot;
     The quantities or concentrations of inhibitors,
neutralizers, and preservatives, if present, in the test material;
     For a culture-based test method, the volume of test
material that results in a dilution of the product that was determined
not to be bacteriostatic or fungistatic; and
     For a non-culture-based test method, the volume of test
material that results in a dilution of the product that does not
inhibit or otherwise hinder the detection of viable contaminating
microorganisms.

E. What is required to verify the sterility test?

    Verification activities are necessary to demonstrate that sterility
test methods can continue to reliably and consistently detect viable
contaminating microorganisms. The degree of verification necessary
depends upon the sterility test method employed. Depending upon the
sterility test method, verification of each individual test might be
appropriate. On the other hand, some sterility test methods may only
need verification activities performed on the selected culture media or
test organisms. We propose under Sec.  610.12(e) that manufacturers
perform verification activities appropriate for the sterility test
method chosen as follows:
    1. For culture-based test methods, manufacturers must conduct tests
to demonstrate that the performance of the test organisms and culture
media are acceptable to consistently detect the presence of viable
contaminating microorganisms, including tests for each lot of culture
media to verify its growth-promoting properties over the shelf-life of
the media. Growth-promotion testing is important to demonstrate that
the culture media are capable of supporting the growth of
microorganisms.
    2. For non-culture-based test methods, manufacturers must include,
within the test itself, appropriate controls to demonstrate the ability
of the test method to continue to reliably and consistently detect the
presence of viable contaminating microorganisms.

F. Can a sterility test be repeated?

    Current regulations in Sec.  610.12(b) allow one time repeat
testing of the bulk material to verify results after a positive initial
test. Repeat testing for final container sterility testing is permitted
twice, provided there was no evidence of growth in any test of the bulk
material. Under current Sec.  610.12(c), a lot meets the test
requirements for sterility if no growth appears during the repeat
tests. We propose to eliminate the reference to repeat testing of bulk
material, because we are proposing that sterility testing will not be
required on bulk material in most instances.\9\ We further propose to
modify the provision for repeat testing to harmonize our regulatory
expectations with current scientific understanding of quality
manufacturing controls by eliminating the use of a second repeat test
for final container material.
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    \9\ See section III.A of this document for discussion of when
sterility testing of bulk material may be appropriate.
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    Consistent with USP Chapter 71, we propose that if the initial test
indicates

the presence of microorganisms, then the product being examined does
not comply with the sterility test requirements, unless a thorough
investigation by the quality control unit can conclusively ascribe the
initial evidence of microbial presence to a laboratory error or faulty
materials used in conducting the test. If the test of the initial
sample is found to be invalid, due to laboratory error or faulty test
materials, the sterility test may be repeated one time. If no evidence
of microorganisms is found in the repeat test, the product examined
complies with the test requirements for sterility; if evidence of
microorganisms is found in the repeat test, the product examined does
not comply with the test requirements for sterility (USP Chapter
71).\10\
---------------------------------------------------------------------------

    \10\ See also Barr, Fish, and Schwemer, Application of
Pharmaceutical CGMPs, the Food and Drug Law Institute, p. 149, (``In
the case of a clearly identified laboratory error, the retest
results substitute for the original test results * * * If, on the
other hand, no laboratory error could be identified in the first
test, then there is no scientific basis for discarding the initial
out-of-specification results in favor of passing retest results''),
1997.
---------------------------------------------------------------------------

    We further propose that for repeat testing, comparable product that
is reflective of the initial sample in terms of sample location and the
stage in the manufacturing process from which it was taken, and the
same sterility test method must be used for both the initial and repeat
tests. This is intended to ensure that the same volume of material is
used for the initial test and each repeat test, and that the
interpretation of the results is conducted in the same manner.
    This proposed rule, if finalized, could result in the need for some
manufacturers to modify their repeat test procedures. We consider these
modifications to be minor changes in accordance with Sec.  601.12(d)
and to have a minimal potential for an adverse effect on the identity,
strength, quality, purity, or potency of the product as they may relate
to the safety or effectiveness of the product. Therefore, such changes
must be reported in an annual report within 60 days of the anniversary
date of approval of the BLA.

G. What records must be kept relating to sterility testing?

    Currently, Sec.  610.12(h) incorporates by reference the
recordkeeping and maintenance requirements contained in 21 CFR 211.167
and 211.194. We propose to continue to maintain these requirements.
This is intended to assure that data derived from sterility tests
comply with established specifications. This includes describing the
samples received for testing, stating the method used to test the
samples, identifying the location of relevant validation or
verification data, recording all calculations performed, and stating
how the results of tests performed compare to set specifications.

H. Are there any exceptions to sterility test requirements?

    We propose to maintain the current exceptions to the sterility test
requirements in Sec.  610.12(g)(4)(i) for Whole Blood, Cryoprecipitated
AHF, Platelets, Red Blood Cells, Plasma, Source Plasma, Smallpox
Vaccine, Reagent Red Blood Cells, Anti-Human Globulin, and Blood
Grouping Reagent. However, we request comment on whether any of these
current exceptions should be removed. For example, we specifically
request comment on whether to remove the exemption for platelets.
Bacterial contamination of platelets is a recognized public health risk
and the blood collection industry has already called for and
implemented methods to detect and limit or inactivate bacteria in
platelet components. Requiring testing for platelets would be
consistent with these industry practices.
    We propose to make minor modifications to the current exception in
Sec.  610.12(g)(4)(ii), under which the Director of CBER or CDER, as
appropriate, determines that data submitted adequately establish that
the mode of administration, the method of preparation, or the special
nature of the product precludes or does not require a sterility test or
that the sterility of the lot is not necessary to assure the safety,
purity, and potency of the product. Specifically, we refer to the
``route of administration'' rather than the ``mode of administration''
and to the ``any other aspect of the product'' rather than ``the
special nature of the product'' in proposed Sec.  610.12(h)(2) so as to
account for novel products that may be introduced to the market in the
future, such as cell and gene therapy products. This proposed exception
allows the Director of CBER or CDER, as appropriate, to exempt
biological material from the sterility test requirements of this
section if, based upon the scientific evidence presented in the BLA or
BLA supplement, the data adequately establish that the route of
administration, method of preparation, or any other aspect of the
product precludes or does not necessitate a sterility test to assure
the safety, purity, and potency of the product. This proposed exception
also would allow the Director of CBER or CDER, as appropriate, to
require sterility testing of the bulk material subject to any
conditions necessary to assure the safety, purity, and potency of the
product.
    We propose to eliminate the current exceptions under Sec.
610.12(g)(1) and (g)(2) because they are no longer necessary given the
flexibility built into this proposal. Specifically, the current
exception in Sec.  610.12(g)(1) allows for the use of different
sterility test methods prescribed for certain products. We further
propose to eliminate the current exception under Sec.  610.12(g)(2),
for using two sterility tests, one at incubation temperatures of
18[deg] to 22 [deg]C and one at 30[deg] to 37 [deg]C, in lieu of
performing one test using an incubation temperature of 30[deg] to 35
[deg]C. The proposed language in Sec.  610.12(b) requires the sterility
test used to be ``* * * appropriate to the material being tested * *
*'' and proposed Sec.  610.12(c) requires manufacturers to specify
incubation conditions (time and temperature) in written procedures for
sterility testing when culture-based media are used. These proposed
changes are intended to provide sufficient flexibility for the use of
different sterility test methods, as appropriate.
    We propose to eliminate the current exceptions for Number of final
containers more than 20, less than 200 (Sec.  610.12(g)(5)), Number of
final containers--20 or less, (Sec.  610.12(g)(6)), Samples--large
volume of product in final containers, (Sec.  610.12(g)(7)), and Immune
globulin preparations. (Sec.  610.12(g)(9)). Instead, we propose to
require manufacturers to determine the appropriate sample volume and
size for the material being tested. (See proposed Sec.  610.12(d).)
Similarly, we propose to eliminate the special requirements in the
Diagnostic biological products not intended for injection exception
(Sec.  610.12(g)(8)). We believe the special requirements in current
Sec.  610.12(g)(8) are no longer necessary because proposed Sec.
610.12(b)(1) requires the sterility test to be ``appropriate to the
material being tested'' and proposed Sec.  610.12(d) requires
manufacturers to determine the appropriate sample volume and size for
the material being tested.

IV. Proposed Revisions to Other Regulations

    In addition to the revisions to the sterility regulation in Sec.
610.12, we are also proposing revisions to two other FDA regulations as
a result of this proposed rule. These proposed revisions are as
follows:
     Section 600.3(q): Current Sec.  600.3(q) defines
``sterility'' to mean ``* * * freedom from viable contaminating
microorganisms, as determined by the

tests prescribed in Sec.  610.12 of this chapter.'' We are proposing to
reword this definition to eliminate the term ``prescribed'' since, as
proposed, Sec.  610.12 would not prescribe specific test methods. Thus,
we are proposing to amend Sec.  600.3(q) to define ``sterility'' as ``*
* * freedom from viable contaminating microorganisms, as determined by
tests conducted under Sec.  610.12 of this chapter.''
     Section 680.3(c): Currently, Sec.  680.3(c) states that:
``A sterility test shall be performed on each lot of each Allergenic
Product, as prescribed in Sec.  610.12 of this chapter, with the
following exceptions: * * * When bulk material is not prepared, the
sterility test prescribed for bulk material shall be performed on each
container of each stock concentrate at the time a stock concentrate is
prepared, and the test sample shall be no less than 1 ml. from each
stock concentrate container. * * * For lots consisting of no more than
5 final containers, the final container test shall be performed in
accordance with Sec.  610.12(g)(6) of this chapter using the sample
therein prescribed or using a sample of no less than 0.25 ml. of
product from each final container, divided in approximately equal
proportions for testing in Fluid Thioglycollate and Soybean-Casein
Digest Media. The test sample in the later alternative method may be an
overfill in the final container. * * * For products prepared in sets of
individual dilution series, a test sample of 0.25 ml. shall be taken
from a final container of each dilution, which samples may be pooled
and one half of the pooled material used for the test with Fluid
Thioglycollate Medium and one half used for the test with Soybean-
Casein Digest Medium. * * * Tablets and capsules need not be tested for
sterility provided aseptic techniques are employed in their
manufacture.''
    We are proposing to amend Sec.  680.3(c) to eliminate the term
``prescribed''. As proposed, Sec.  680.3(c) would say that ``a
sterility test shall be performed on each lot of each Allergenic
Product, as required by Sec.  610.12 of this chapter.'' Additionally,
we are proposing to eliminate Sec.  680.3(c)(1) through (c)(4), because
these exceptions would no longer be necessary under the proposed
revisions to Sec.  610.12. As proposed Sec.  610.12 would eliminate the
sterility test requirement on most bulk material, so the exception in
Sec.  680.3(c)(1) of how to test allergenic products when bulk material
is not prepared, would no longer be needed. To the extent it is
appropriate to perform the sterility test on bulk product for
allergenics, the approach for such testing will be explained in the BLA
or BLA supplement that is submitted by the manufacturer and approved by
FDA. Moreover, Sec.  610.12, as proposed, would not prescribe a
specific sample number and would not contain the specific exemption in
Sec.  610.12(g)(6) referenced in Sec.  680.3(c)(2). The proposed
requirement that the sample be appropriate to the materials being
tested would accommodate the situation envisioned by current Sec.
680.83(c)(2) for lots consisting of no more than five final containers.
Current Sec.  680.83(c)(3) should similarly be accommodated by the
flexible language of the proposal such that sterility tests for sets of
individual dilution series can be done on test samples that are
appropriate to these material and thus a specific exception would no
longer be needed for the sterility testing of these products. Finally,
current Sec.  680.83(c)(4) would be accommodated by the general
exception in proposed Sec.  610.12(h)(2) and thus this fourth exception
would also be rendered unnecessary.

V. Legal Authority

    FDA is issuing this regulation under the biological products
provisions of the Public Health Service Act (42 U.S.C. 262 and 264) and
the drugs and general administrative provisions of the Federal Food,
Drug, and Cosmetic Act (sections 201, 301, 501, 502, 503, 505, 510,
701, and 704) (21 U.S.C. 321, 331, 351, 352, 353, 355, 360, 371, and
374). Under these provisions of the Public Health Service Act and the
Federal Food, Drug, and Cosmetic Act, we have the authority to issue
and enforce regulations designed to ensure that biological products are
safe, effective, pure, and potent, and to prevent the introduction,
transmission, and spread of communicable disease.

VI. Analysis of Impacts

    FDA has examined the impacts of the proposed rule under Executive
Order 12866 and the Regulatory Flexibility Act (5 U.S.C. 601-612), and
the Unfunded Mandates Reform Act of 1995 (Public Law 104-4). Executive
Order 12866 directs 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 Agency believes that
this proposed rule is not a significant regulatory action as defined by
the Executive order.
    The Regulatory Flexibility Act requires Agencies to analyze
regulatory options that would minimize any significant impact of a rule
on small entities. Because this proposed rule generally increases
flexibility for sterility testing and codifies an approach for
retesting similar to the approach prescribed by the USP, and does not
add any new regulatory responsibilities, the Agency proposes to certify
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 proposing ``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 $135 million, using the most current (2009) Implicit
Price Deflator for the Gross Domestic Product. FDA does not expect this
proposed rule to result in any 1-year expenditure that would meet or
exceed this amount.
    These amendments would generally provide manufacturers of
biological products with more flexibility as to how they evaluate the
sterility of their products and reduce the number of evaluations
required. The net effect would be to reduce costs.
    One part of these proposed amendments might impose some additional
costs on manufacturers, however. Under the current regulations, if a
biological product fails a sterility test, the test may be repeated. If
the product passes a subsequent test, it is inferred that the first
test was flawed and only the later results are used. Under the new
regulations, the test may be repeated only if it is possible to
``ascribe definitively'' the initial failure to ``a laboratory error or
faulty materials used in conducting the sterility testing.''
    This change could increase costs for manufacturers because of the
additional products that would be discarded. The size of the increase
would be determined by the number of additional lots discarded, the lot
sizes and the production costs per unit. Some or all of the costs of
this change would be mitigated by the reduction in losses associated
with the provision of contaminated products.
    This change is expected to affect few manufacturers. The method for
sterility testing described in Chapter 71 of USP 33-NF 28 already
limits the repetition of tests to circumstances similar to those
described in these amendments. It is

anticipated that, in the absence of these amendments, the majority of
manufacturers would limit the repetition of sterility tests in order to
comply with USP Chapter 71. The Agency invites comment on the frequency
with which manufacturers diverge from the retesting protocol of these
amendments and the costs that limiting retests will impose.
    The benefit of limiting retests would be fewer illnesses caused by
contaminated biological products. We are unable to quantify the value
of the reduction in illnesses because we do not have an estimate of the
risk of illness from contaminated biological products or the decline in
that risk associated with limiting retests.

VII. Environmental Impact

    The Agency has determined under 21 CFR 25.31(h) that this action is
of a type that does not individually or cumulatively have a significant
effect on the human environment. Therefore, neither an environmental
assessment nor an environmental impact statement is required.

VIII. The Paperwork Reduction Act of 1995

    This proposed rule refers to previously approved collections of
information that are subject to review by the Office of Management and
Budget (OMB) under the Paperwork Reduction Act of 1995 (the PRA) (44
U.S.C. 3501-3520). The collections of information in Sec. Sec.  211.165
and 610.12 have been approved under OMB control number 0910-0139.
Therefore, FDA tentatively concludes that the proposed requirements in
this document are not subject to review by OMB because they do not
constitute a ``new collection of information'' under the PRA.

IX. Federalism

    FDA has analyzed this proposed rule in accordance with the
principles set forth in Executive Order 13132. FDA has determined that
the proposed rule does not contain policies that have substantial
direct effects on the States, on the relationship between the National
Government and the States, or on the distribution of power and
responsibilities among the various levels of government. Accordingly,
the Agency has concluded that the proposed rule does not contain
policies that have federalism implications as defined in the Executive
order and, consequently, a federalism summary impact statement is not
required.

X. Proposed Effective Date

    FDA is proposing that any final rule that may issue based on this
proposal be effective 90 days after the date of its publication in the
Federal Register.

XI. Request for Comments

    Interested persons may submit to the Division of Dockets Management
(see ADDRESSES) either electronic or written comments regarding this
document. It is only necessary to send one set of comments. It is no
longer necessary to send two copies of mailed comments. Identify
comments with the docket number found in brackets in the heading of
this document. Received comments may be seen in the Division of Dockets
Management between 9 a.m. and 4 p.m., Monday through Friday.

List of Subjects

21 CFR Part 600

    Biologics, Reporting and recordkeeping requirements.

21 CFR Part 610

    Biologics, Labeling, Reporting and recordkeeping requirements.

21 CFR Part 680

    Biologics, Blood, Reporting and recordkeeping requirements.

    Therefore, under the Federal Food, Drug, and Cosmetic Act, the
Public Health Service Act, and under authority delegated to the
Commissioner of Food and Drugs, it is proposed that 21 CFR parts 600,
610, and 680 be amended as follows:

PART 600--BIOLOGICAL PRODUCTS: GENERAL

    1. The authority citation for 21 CFR part 600 continues to read as
follows:

    Authority: 21 U.S.C. 321, 351, 352, 353, 355, 360, 360i, 371,
374; 42 U.S.C. 216, 262, 263, 263a, 264, 300aa-25.

Sec.  600.3  [Amended]

    2. Section 600.3 is amended in paragraph (q) by removing the phrase
``prescribed in'' and by adding in its place the phrase ``conducted
under''.

PART 610--GENERAL BIOLOGICAL PRODUCTS STANDARDS

    3. The authority citation for 21 CFR part 610 continues to read as
follows:

    Authority: 21 U.S.C. 321, 331, 351, 352, 353, 355, 360, 360c,
360d, 360h, 360i, 371, 372, 374, 381; 42 U.S.C. 216, 262, 263, 263a,
264.

    4. Section 610.12 is revised to read as follows:

Sec.  610.12  Sterility.

    (a) The test. Except as provided in paragraph (h) of this section,
manufacturers of biological products must perform sterility testing of
each lot of each biological product's final container material or other
material, as appropriate and as approved in the biologics license
application or supplement for that product.
    (b) Test requirements. (1) The sterility test must be appropriate
to the material being tested such that the material does not interfere
with or otherwise hinder the test.
    (2) The sterility test must be validated to demonstrate that the
test is capable of reliably and consistently detecting the presence of
viable contaminating microorganisms.
    (3) The sterility test and test components must be verified to
demonstrate that the test method can consistently detect the presence
of viable contaminating microorganisms.
    (c) Written procedures. Manufacturers must establish, implement,
and follow written procedures for sterility testing that describe, at a
minimum, the following:
    (1) The sterility test method to be used;
    (i) If culture-based test methods are used, include, at a minimum:
    (A) Composition of the culture media;
    (B) Growth-promotion test requirements; and
    (C) Incubation conditions (time and temperature).
    (ii) If non-culture-based test methods are used, include, at a
minimum:
    (A) Composition of test components;
    (B) Test parameters, including acceptance criteria; and
    (C) Controls used to verify the method's ability to detect the
presence of viable contaminating microorganisms.
    (2) The method of sampling, including the number, volume, and size
of articles to be tested;
    (3) Written specifications for the acceptance or rejection of each
lot; and
    (4) A statement of any other function critical to the particular
sterility test method to ensure consistent and accurate results.
    (d) The sample. The sample must be appropriate to the material
being tested, considering, at a minimum:
    (1) The size and volume of the final product lot;
    (2) The duration of manufacturing of the drug product;
    (3) The final container configuration and size;
    (4) The quantity or concentration of inhibitors, neutralizers, and
preservatives, if present, in the tested material;

    (5) For a culture-based test method, the volume of test material
that results in a dilution of the product that is not bacteriostatic or
fungistatic; and
    (6) For a non-culture-based test method, the volume of test
material that results in a dilution of the product that does not
inhibit or otherwise hinder the detection of viable contaminating
microorganisms.
    (e) Verification. (1) For culture-based test methods, studies must
be conducted to demonstrate that the performance of the test organisms
and culture media are suitable to consistently detect the presence of
viable contaminating microorganisms, including tests for each lot of
culture media to verify its growth-promoting properties over the shelf-
life of the media.
    (2) For non-culture-based test methods, within the test itself,
appropriate controls must be used to demonstrate the ability of the
test method to continue to consistently detect the presence of viable
contaminating microorganisms.
    (f) Repeat Test Procedures. (1) If the initial test indicates the
presence of microorganisms, the product does not comply with the
sterility test requirements unless a thorough investigation by the
quality control unit can ascribe definitively the microbial presence to
a laboratory error or faulty materials used in conducting the sterility
testing.
    (2) If the investigation described in paragraph (f)(1) of this
section finds that the initial test indicated the presence of
microorganisms due to laboratory error or the use of faulty materials,
a sterility test may be repeated one time. If no evidence of
microorganisms is found in the repeat test, the product examined
complies with the sterility test requirements. If evidence of
microorganisms is found in the repeat test, the product examined does
not comply with the sterility test requirements.
    (3) If a repeat test is conducted, the same test method must be
used for both the initial and repeat tests, and the repeat test must be
conducted with comparable product that is reflective of the initial
sample in terms of sample location and the stage in the manufacturing
process from which it was obtained.
    (g) Records. The records related to the test requirements of this
section must be prepared and maintained as required by 21 CFR 211.167
and 211.194 of this chapter.
    (h) Exceptions. Sterility testing must be performed on final
container material or other appropriate material as defined in the
approved biologics license application or supplement and as described
in this section, except as follows:
    (1) Sterility testing is not required for Whole Blood,
Cryoprecipitated Antihemophilic Factor, Platelets, Red Blood Cells,
Plasma, Source Plasma, Smallpox Vaccine, Reagent Red Blood Cells, Anti-
Human Globulin, and Blood Grouping Reagents.
    (2) A manufacturer is not required to comply with the sterility
test requirements if the Director of the Center for Biologics
Evaluation and Research or the Director of the Center for Devices and
Radiological Health, as appropriate, determines that data submitted in
the biologics license application or supplement adequately establish
that the route of administration, the method of preparation, or any
other aspect of the product precludes or does not necessitate a
sterility test to assure the safety, purity, and potency of the
product.

PART 680--ADDITIONAL STANDARDS FOR MISCELLANEOUS PRODUCTS

    5. The authority citation for 21 CFR part 680 continues to read as
follows:

    Authority: 21 U.S.C. 321, 351, 352, 353, 355, 360, 371; 42
U.S.C. 216, 262, 263, 263a, 264.

    6. Section 680.3 is amended by revising paragraph (c) to read as
follows:

Sec.  680.3  Tests.

* * * * *
    (c) Sterility. A sterility test shall be performed on each lot of
each Allergenic Product as required by Sec.  601.12 of this chapter.

    Dated: June 16, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-15346 Filed 6-20-11; 8:45 am]
BILLING CODE 4160-01-P


[Federal Register Volume 76, Number 31 (Tuesday, February 15, 2011)]
[Notices]
[Page 8726]
[FR Doc No: 2011-3302]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. EF11-4-000]

Western Area Power Administration; Notice of Filing

    Take notice that on February 3, 2011, the Western Area Power
Administration, pursuant to Order No. 714,\1\ and the Federal Energy
Regulatory Commission's (Commission) Order Establishing Baseline Filing
Schedule Starting April 1, 2010, issued on March 19, 2010, 130 FERC ]
61,228 (March 19 Order), resubmitted a new Baseline eTariff version of
its non-jurisdictional Open Access Transmission Tariff, to be effective
September 30, 2010.
---------------------------------------------------------------------------

    \1\ Electronic Tariff Filings, Order No. 714, FERC Stats. &
Regs. ] 31,276 (2008).
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    Any person desiring to intervene or to protest this filing must
file in accordance with Rules 211 and 214 of the Commission's Rules of
Practice and Procedure (18 CFR 385.211, 385.214). Protests will be
considered by the Commission in determining the appropriate action to
be taken, but will not serve to make protestants parties to the
proceeding. Any person wishing to become a party must file a notice of
intervention or motion to intervene, as appropriate. Such notices,
motions, or protests must be filed on or before the comment date. On or
before the comment date, it is not necessary to serve motions to
intervene or protests on persons other than the Applicant.
    The Commission encourages electronic submission of protests and
interventions in lieu of paper using the ``eFiling'' link at http://www.ferc.gov. Persons unable to file electronically should submit an
original and 14 copies of the protest or intervention to the Federal
Energy Regulatory Commission, 888 First Street, NE., Washington, DC
20426.
    This filing is accessible on-line at http://www.ferc.gov, using the
``eLibrary'' link and is available for review in the Commission's
Public Reference Room in Washington, DC. There is an ``eSubscription''
link on the Web site that enables subscribers to receive e-mail
notification when a document is added to a subscribed docket(s). For
assistance with any FERC Online service, please e-mail
<EMAIL_ADDRESS>or call<PHONE_NUMBER> (toll free). For
TTY, call<PHONE_NUMBER>.
    Comment Date: 5 p.m. Eastern Time on February 17, 2011.

    Dated: February 8, 2011.
Kimberly D. Bose,
Secretary.
[FR Doc. 2011-3302 Filed 2-14-11; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 76, Number 174 (Thursday, September 8, 2011)]
[Proposed Rules]
[Page 55622]
[FR Doc No: 2011-22988]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 721

[EPA-HQ-OPPT-2009-0767; FRL-8888-7]
RIN 2070-AJ52

Glymes; Proposed Significant New Use; Extension of Comment Period

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule; extension of comment period.

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

SUMMARY: EPA issued a proposed rule in the Federal Register of July 12,
2011, concerning a proposed significant new use rule (SNUR) under
section 5(a)(2) of the Toxic Substances Control Act (TSCA) for 14
glymes. Since publication, EPA has received a request for additional
time to submit comments. This document extends the comment period for
30 days, from September 12, 2011 to October 12, 2011.

DATES: Comments, identified by docket identification (ID) number EPA-
HQ-OPPT-2009-0767, must be received on or before October 12, 2011.

ADDRESSES: Follow the detailed instructions as provided under ADDRESSES
in the Federal Register document of July 12, 2011.

FOR FURTHER INFORMATION CONTACT: For technical information contact: Amy
Breedlove, Chemical Control Division (7405M), Office of Pollution
Prevention and Toxics, Environmental Protection Agency, 1200
Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone number:
(202) 564-9823; e-mail address<EMAIL_ADDRESS>    For general information contact: The TSCA-Hotline, ABVI-Goodwill,
422 South Clinton Ave., Rochester, NY 14620; telephone number: (202)
554-1404; e-mail address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:
    This document extends the public comment period established in the
Federal Register of July 12, 2011 (76 FR 40850) (FRL-8877-8). In that
document, EPA proposed a SNUR for 14 glymes, designated proposed
significant new uses for the 14 glymes, and asked for public comment on
several topics. EPA requested comment on whether any of the chemical
substances included in the identified glyme category are sufficiently
dissimilar from the rest such that they should be removed from the
category, or whether any additional chemical substances are
sufficiently similar such that they should be added to the category.
Comments were also requested on whether any of the additional
unconfirmed uses listed in the proposed rule are actual ongoing uses in
a consumer product, and whether there are any other ongoing uses in a
consumer product of the other chemicals listed in the SNUR. EPA is
hereby extending the comment period, which was set to end on September
12, 2011, to October 12, 2011.
    To submit comments, or access the docket, please follow the
detailed instructions as provided under ADDRESSES in the July 12, 2011
Federal Register document. If you have questions, consult the technical
person listed under FOR FURTHER INFORMATION CONTACT.

List of Subjects in 40 CFR Part 721

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

    Dated: September 1, 2011.
Maria J. Doa,
Director, Chemical Control Division, Office of Pollution Prevention and
Toxics.
[FR Doc. 2011-22988 Filed 9-7-11; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 77, Number 85 (Wednesday, May 2, 2012)]
[Notices]
[Pages 26002-26004]
[FR Doc No: 2012-10342]

=======================================================================
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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPP-2012-0257; FRL-9344-6]

Diflubenzuron; Receipt of Application for Emergency Exemptions,
Solicitation of Public Comment

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: EPA has received a specific exemption request from the Wyoming
Department of Agriculture to use the pesticide diflubenzuron to treat
up to 26,000 acres of alfalfa to control grasshoppers and Mormon
crickets. The applicant proposes a use which is supported by the
Interregional (IR)-4 program and has been requested in 5 or more
previous years, and a petition for tolerance has not yet been submitted
to the Agency. EPA is soliciting public comment before making the
decision whether or not to grant the exemption.

DATES: Comments must be received on or before May 17, 2012.

ADDRESSES: Submit your comments, identified by docket identification
(ID) number EPA-HQ-OPP-2012-0257, by one of the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov.
Follow the online instructions for submitting comments.
     Mail: Office of Pesticide Programs (OPP) Regulatory Public
Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania Ave.
NW., Washington, DC 20460-0001.
    Delivery: OPP Regulatory Public Docket (7502P), Environmental
Protection Agency, Rm. S-4400, One Potomac Yard (South Bldg.), 2777 S.
Crystal Dr., Arlington, VA. Deliveries are only accepted during the
Docket Facility's normal hours of operation (8:30 a.m. to 4 p.m.,
Monday through Friday, excluding legal holidays). Special arrangements
should be made for deliveries of boxed information. The Docket Facility
telephone number is<PHONE_NUMBER>.
    Instructions: Direct your comments to docket ID number EPA-HQ-OPP-
2012-0257. EPA's policy is that all comments received will be included
in the docket without change and may be made available online at http://www.regulations.gov, including any personal information provided,
unless the comment includes information claimed to be Confidential
Business Information (CBI) or other information whose disclosure is
restricted by statute. Do not submit information that you consider to
be CBI or otherwise protected through regulations.gov or

email. The regulations.gov Web site is an ``anonymous access'' system,
which means EPA will not know your identity or contact information
unless you provide it in the body of your comment. If you send an email
comment directly to EPA without going through regulations.gov, your
email address will be automatically captured and included as part of
the comment that is placed in the docket and made available on the
Internet. If you submit an electronic comment, EPA recommends that you
include your name and other contact information in the body of your
comment and with any disk or CD-ROM you submit. If EPA cannot read your
comment due to technical difficulties and cannot contact you for
clarification, EPA may not be able to consider your comment. Electronic
files should avoid the use of special characters, any form of
encryption, and be free of any defects or viruses.
    Docket: All documents in the docket are listed in the docket index
available at http://www.regulations.gov. Although listed in the index,
some information is not publicly available, e.g., CBI or other
information whose disclosure is restricted by statute. Certain other
material, such as copyrighted material, is not placed on the Internet
and will be publicly available only in hard copy form. Publicly
available docket materials are available either in the electronic
docket at http://www.regulations.gov, or, if only available in hard
copy, at the OPP Regulatory Public Docket in Rm. S-4400, One Potomac
Yard (South Bldg.), 2777 S. Crystal Dr., Arlington, VA. The hours of
operation of this Docket Facility are from 8:30 a.m. to 4 p.m., Monday
through Friday, excluding legal holidays. The Docket Facility telephone
number is<PHONE_NUMBER>.

FOR FURTHER INFORMATION CONTACT: Andrea Conrath, Registration Division
(7505P), Office of Pesticide Programs, Environmental Protection Agency,
1200 Pennsylvania Ave. NW., Washington, DC 20460-0001; telephone
number:<PHONE_NUMBER> fax number:<PHONE_NUMBER>; email address:
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this action apply to me?

    You may be potentially affected by this action if you are an
agricultural producer, food manufacturer, or pesticide manufacturer.
Potentially affected entities may include, but are not limited to:
     Crop production (NAICS code 111).
     Animal production (NAICS code 112).
     Food manufacturing (NAICS code 311).
     Pesticide manufacturing (NAICS code 32532).
    This listing is not intended to be exhaustive, but rather provides
a guide for readers regarding entities likely to be affected by this
action. Other types of entities not listed in this unit could also be
affected. The North American Industrial Classification System (NAICS)
codes have been provided to assist you and others in determining
whether this action might apply to certain entities. 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. What should I consider as I prepare my comments for EPA?

    1. Submitting CBI. Do not submit this information to EPA through
www.regulations.gov or email. Clearly mark the part or all of the
information that you claim to be CBI. For CBI information in a disk or
CD-ROM that you mail to EPA, mark the outside of the disk or CD-ROM as
CBI and then identify electronically within the disk or CD-ROM the
specific information that is claimed as CBI. In addition to one
complete version of the comment that includes information claimed as
CBI, a copy of the comment that does not contain the information
claimed as CBI must be submitted for inclusion in the public docket.
Information so marked will not be disclosed except in accordance with
procedures set forth in 40 CFR part 2.
    2. Tips for preparing your comments. When submitting comments,
remember to:
    i. Identify the document by docket ID number and other identifying
information (subject heading, Federal Register date and page number).
    ii. Follow directions. The Agency may ask you to respond to
specific questions or organize comments by referencing a Code of
Federal Regulations (CFR) part or section number.
    iii. Explain why you agree or disagree; suggest alternatives and
substitute language for your requested changes.
    iv. Describe any assumptions and provide any technical information
and/or data that you used.
    v. If you estimate potential costs or burdens, explain how you
arrived at your estimate in sufficient detail to allow for it to be
reproduced.
    vi. Provide specific examples to illustrate your concerns and
suggest alternatives.
    vii. Explain your views as clearly as possible, avoiding the use of
profanity or personal threats.
    viii. Make sure to submit your comments by the comment period
deadline identified.
    3. Environmental justice. EPA seeks to achieve environmental
justice, the fair treatment and meaningful involvement of any group,
including minority and/or low income populations, in the development,
implementation, and enforcement of environmental laws, regulations, and
policies. To help address potential environmental justice issues, the
Agency seeks information on any groups or segments of the population
who, as a result of their location, cultural practices, or other
factors, may have atypical or disproportionately high and adverse human
health impacts or environmental effects from exposure to the
pesticide(s) discussed in this document, compared to the general
population.

II. What action is the Agency taking?

    Under section 18 of the Federal Insecticide, Fungicide, and
Rodenticide Act (FIFRA) (7 U.S.C. 136p), at the discretion of the
Administrator, a Federal or State agency may be exempted from any
provision of FIFRA if the Administrator determines that emergency
conditions exist which require the exemption. The Wyoming Department of
Agriculture has requested the Administrator to issue a specific
exemption for the use of diflubenzuron (CAS Reg. No. 35367-38-5) on
alfalfa to control grasshoppers and Mormon crickets. Information in
accordance with 40 CFR part 166 was submitted as part of these
requests.
    As part of the request, the applicant asserts that projected
population levels for these damaging insect pests are higher than
normal for the 2012 season. The applicant claims that registered
alternatives will not provide adequate control to avert significant
economic losses from occurring.
    The Applicant proposes to make no more than two applications of
diflubenzuron, at a rate of 0.032 lbs. active ingredient (a.i.)
(equivalent to 2 fl. oz. of product containing 2 lbs. a.i. per gallon).
Application could be made on up to 26,000 acres of alfalfa, from the
date of approval, if granted, until October 31, 2012, in the state of
Wyoming. If the maximum proposed acreage were treated at the maximum
rate, a total of 814 lbs. active ingredient (407 gallons formulated
product) could be applied.
    This notice does not constitute a decision by EPA on the
applications themselves. The regulations governing

section 18 of FIFRA require publication of a notice of receipt of an
application for a specific exemption proposing a use which is supported
by the IR-4 program and has been requested in 5 or more previous years,
and a petition for tolerance has not yet been submitted to the Agency.
The notice provides an opportunity for public comment on the
applications.
    The Agency, will review and consider all comments received during
the comment period in determining whether to issue the specific
exemptions requested by the Wyoming Department of Agriculture.

List of Subjects

    Environmental protection, Pesticides and pests.

    Dated: April 19, 2012.
 Daniel J. Rosenblatt,
Acting Director, Registration Division, Office of Pesticide Programs.
[FR Doc. 2012-10342 Filed 5-1-12; 8:45 am]
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[Federal Register Volume 82, Number 180 (Tuesday, September 19, 2017)]
[Rules and Regulations]
[Pages 43699-43701]
[FR Doc No: 2017-19817]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-R01-OAR-2016-0110; FRL-9967-88-Region 1]

Air Plan Approval; Maine; Regional Haze 5-Year Progress Report

AGENCY: Environmental Protection Agency.

ACTION: Final rule.

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SUMMARY: The Environmental Protection Agency (EPA) is approving a State
Implementation Plan (SIP) revision submitted by the State of Maine on
February 23, 2016. Maine's SIP revision addresses requirements of the
Clean Air Act (CAA) and EPA's rules that require States to submit
periodic reports describing progress toward reasonable progress goals
(RPGs) established for regional haze and a determination of the
adequacy of the State's existing regional haze SIP. Maine's progress
report notes that Maine has implemented the measures in the regional
haze SIP due to be in place by the date of the progress

report and that visibility in federal Class I areas affected by
emissions from Maine is improving and has already met the applicable
RPGs for 2018. Maine also determined that the State's regional haze SIP
is adequate to meet these reasonable progress goals for the first
implementation period covering through 2018 and requires no substantive
revision at this time.

DATES: This rule is effective on October 19, 2017.

ADDRESSES: EPA has established a docket for this action under Docket
Identification No. EPA-R01-OAR-2016-0110. All documents in the docket
are listed on the http://www.regulations.gov Web site. Although listed
in the index, some information is not publicly available, i.e., CBI or
other information whose disclosure is restricted by statute. Certain
other material, such as copyrighted material, is not placed on the
Internet and will be publicly available only in hard copy form.
Publicly available docket materials are available at http://www.regulations.gov or at the U.S. Environmental Protection Agency, EPA
New England Regional Office, Office of Ecosystem Protection, Air
Quality Planning Unit, 5 Post Office Square--Suite 100, Boston, MA. EPA
requests that if at all possible, you contact the contact listed in the
FOR FURTHER INFORMATION CONTACT section to schedule your inspection.
The Regional Office's official hours of business are Monday through
Friday, 8:30 a.m. to 4:30 p.m., excluding legal holidays.

FOR FURTHER INFORMATION CONTACT: Anne McWilliams, Air Quality Unit,
U.S. Environmental Protection Agency, EPA New England Regional Office,
5 Post Office Square--Suite 100, (Mail Code OEP05-02), Boston, MA
02109-3912, telephone number<PHONE_NUMBER>, fax number<PHONE_NUMBER>,
email<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Throughout this document whenever ``we,''
``us,'' or ``our'' is used, we mean EPA.

Table of Contents

I. Background
II. Final Action
III. Incorporation by Reference
IV. Statutory and Executive Order Reviews

I. Background

    States are required to submit a progress report in the form of a
SIP revision every five years that evaluates progress towards the RPGs
for each mandatory Class I Federal area within the state and in each
mandatory Class I Federal area outside the state which may be affected
by emissions from within the state. See 40 CFR 51.308(g). In addition,
the provisions under 40 CFR 51.308(h) require States to submit, at the
same time as the 40 CFR 51.308(g) progress report, a determination of
the adequacy of the state's existing regional haze SIP. The first
progress report SIP is due five years after submittal of the initial
regional haze SIP.
    On July 20, 2017 (82 FR 33471), EPA published a notice of proposed
rulemaking (NPR) proposing approval of Maine's February 23, 2016
Regional Haze 5-Year Progress Report SIP revision on the basis that it
satisfies the requirements of 40 CFR 51.308(g) and (h).
    The specific details of Maine's February 23, 2016 SIP revision and
the rationale for EPA's approval are discussed in the NPR and will not
be restated here. EPA received one comment agreeing with EPA's
assessment of Maine's February 23, 2016 Regional Haze 5-Year Progress
Report.

II. Final Action

    EPA is approving Maine's February 23, 2016 Regional Haze 5-Year
Progress Report SIP submittal as meeting the requirements of 40 CFR
51.308(g) and (h).

III. Incorporation by Reference

    In this rule, the EPA is finalizing regulatory text that includes
incorporation by reference. In accordance with requirements of 1 CFR
51.5, the EPA is finalizing the incorporation by reference of New
Hampshire's regulation described in the amendments to 40 CFR part 52
set forth below. The EPA has made, and will continue to make, these
documents generally available through http://www.regulations.gov.

IV. Statutory and Executive Order Reviews

    Under the Clean Air Act, the Administrator is required to approve a
SIP submission that complies with the provisions of the Act and
applicable Federal regulations. 42 U.S.C. 7410(k); 40 CFR 52.02(a).
Thus, in reviewing SIP submissions, EPA's role is to approve state
choices, provided that they meet the criteria of the Clean Air Act.
Accordingly, this action merely approves state law as meeting Federal
requirements and does not impose additional requirements beyond those
imposed by state law. For that reason, this action:
     Is not a significant regulatory action subject to review
by the Office of Management and Budget under Executive Orders 12866 (58
FR 51735, October 4, 1993) and 13563 (76 FR 3821, January 21, 2011);
     Does not impose an information collection burden under the
provisions of the Paperwork Reduction Act (44 U.S.C. 3501 et seq.);
     Is certified as not having a significant economic impact
on a substantial number of small entities under the Regulatory
Flexibility Act (5 U.S.C. 601 et seq.);
     Does not contain any unfunded mandate or significantly or
uniquely affect small governments, as described in the Unfunded
Mandates Reform Act of 1995 (Pub. L. 104-4);
     Does not have Federalism implications as specified in
Executive Order 13132 (64 FR 43255, August 10, 1999);
     Is not an economically significant regulatory action based
on health or safety risks subject to Executive Order 13045 (62 FR
19885, April 23, 1997);
     Is not a significant regulatory action subject to
Executive Order 13211 (66 FR 28355, May 22, 2001);
     Is not subject to requirements of section 12(d) of the
National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272
note) because application of those requirements would be inconsistent
with the Clean Air Act; and
     Does not provide EPA with the discretionary authority to
address, as appropriate, disproportionate human health or environmental
effects, using practicable and legally permissible methods, under
Executive Order 12898 (59 FR 7629, February 16, 1994).
    In addition, the SIP is not approved to apply on any Indian
reservation land or in any other area where EPA or an Indian tribe has
demonstrated that a tribe has jurisdiction. In those areas of Indian
country, the rule does not have tribal implications and will not impose
substantial direct costs on tribal governments or preempt tribal law as
specified by Executive Order 13175 (65 FR 67249, November 9, 2000).

    The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the
Small Business Regulatory Enforcement Fairness Act of 1996, generally
provides that before a rule may take effect, the agency promulgating
the rule must submit a rule report, which includes a copy of the rule,
to each House of the Congress and to the Comptroller General of the
United States. EPA will submit a report containing this action and
other required information to the U.S. Senate, the U.S. House of
Representatives, and the Comptroller General of the United States prior
to publication of the rule in the Federal Register. A major rule cannot
take effect until 60 days after it is published in the Federal
Register. This action is not a ``major rule'' as defined by 5 U.S.C.
804(2).
    Under section 307(b)(1) of the Clean Air Act, petitions for
judicial review of this action must be filed in the United States Court
of Appeals for the appropriate circuit by November 20, 2017. Filing a
petition for reconsideration by the Administrator of this final rule
does not affect the finality of this action for the purposes of
judicial review nor does it extend the time within which a petition for
judicial review may be filed, and shall not postpone the effectiveness
of such rule or action. This action may not be challenged later in
proceedings to enforce its requirements. (See section 307(b)(2)).

List of Subjects in 40 CFR Part 52

    Environmental protection, Air pollution control, Carbon monoxide,
Incorporation by reference, Intergovernmental relations, Lead, Nitrogen
dioxide, Ozone, Particulate matter, Regional haze, Reporting and
recordkeeping requirements, Sulfur oxides, Volatile organic compounds.

    Dated: September 7, 2017.
Deborah A. Szaro,
Acting Regional Administrator, EPA New England.

    Part 52 of chapter I, title 40 of the Code of Federal Regulations
is amended as follows:

PART 52--APPROVAL AND PROMULGATION OF IMPLEMENTATION PLANS

0
1. The authority citation for part 52 continues to read as follows:

    Authority:  42 U.S.C. 7401 et seq.

Subpart U--Maine

0
2. In Sec.  52.1020, the table in paragraph (e) is amended by adding
the entry ``Regional Haze 5-Year Progress Report'' at the end of the
table to read as follows:

Sec.  52.1020   Identification of plan.

* * * * *
    (e) * * *

                                                                  Maine Non Regulatory
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                State
        Name of non regulatory SIP  provision             Applicable geographic or     submittal date/   EPA approved date \3\         Explanations
                                                             nonattainment area        effective date
--------------------------------------------------------------------------------------------------------------------------------------------------------

                                                                      * * * * * * *
Regional Haze 5-Year Progress Report................  Statewide......................       2/23/2016  9/19/2017, [insert        Progress report for the
                                                                                Federal Register          first regional haze
                                                                                citation].                planning period ending
                                                                                in 2018.
--------------------------------------------------------------------------------------------------------------------------------------------------------
\3\ In order to determine the EPA effective date for a specific provision listed in this table, consult the Federal Register notice cited in this column
  for the particular provision.

[FR Doc. 2017-19817 Filed 9-18-17; 8:45 am]
 BILLING CODE 6560-50-P


[Federal Register Volume 78, Number 125 (Friday, June 28, 2013)]
[Notices]
[Pages 39062-39063]
[FR Doc No: 2013-15534]

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DEPARTMENT OF TRANSPORTATION

National Highway Traffic Safety Administration

[Docket No. NHTSA-2012-0086]

Group Lotus plc; Modification of a Temporary Exemption From an
Advanced Air Bag Requirement of FMVSS No. 208

AGENCY: National Highway Traffic Safety Administration (NHTSA),
Department of Transportation (DOT).

ACTION: Notice of modification of a temporary exemption from a
provision of Federal Motor Vehicle Safety Standard (FMVSS) No. 208,
Occupant Crash Protection.

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SUMMARY: This notice modifies the temporary exemption granted to Group
Lotus plc (Lotus) on March 8, 2013. The agency granted Lotus an
exemption from the higher maximum speed (56 km/h (35 mph)) belted test
requirement using 5th percentile adult female dummies for the front
passenger position of its Evora model for the period from March 8, 2013
to March 8, 2014. The agency is modifying the dates of the exemption to
account for vehicles Lotus manufactured before the exemption went into
effect.

DATES: NHTSA Temporary Exemption No. EX-13-01 granted to Lotus is
modified to include vehicles imported on or after November 7, 2012. The
termination date of the exemption is modified to be November 7, 2013.

FOR FURTHER INFORMATION CONTACT: David Jasinski, Office of the Chief
Counsel, NCC-112, National Highway Traffic Safety Administration, 1200
New Jersey Avenue SE., West Building 4th Floor, Room W41-326,
Washington, DC 20590. Telephone:<PHONE_NUMBER>; Fax:<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: On March 8, 2013, NHTSA published in the
Federal Register a notice granting Group Lotus Plc (Lotus) a temporary
exemption from the higher maximum speed (56 km/h (35 mph)) belted test
requirement using 5th percentile adult female dummies in Federal Motor
Vehicle Safety Standard (FMVSS) No. 208 for the front passenger
position of its Evora model for the period from March 8, 2013 to March
8, 2014.\1\ This requirement became effective for small manufacturers
such as Lotus as of September 1, 2012.
---------------------------------------------------------------------------

    \1\ 78 FR 15114.
---------------------------------------------------------------------------

    After publication of Lotus's exemption, Lotus informed the agency
of the existence of 51 vehicles that were

manufactured on or after September 1, 2012 and before March 8, 2013
that were imported into the United States. Lotus asserted that these
vehicles were partially manufactured prior to September 1, 2012, but
were not completed until after that date. These 51 vehicles bear
certification labels stating a date of manufacture of August 2012 and
are certified to comply with the standards, including FMVSS No. 208,
applicable as of August 2012.
    For the purpose of FMVSS No. 208 compliance, these vehicles are
identical to those manufactured prior to September 1, 2012 and after
March 8, 2013. However, the vehicles are not certified to be compliant
with the standards in effect as of the date they were actually
manufactured, which include the higher speed belted test requirement
using the 5th percentile adult female dummy. Moreover, the exemption
that NHTSA granted to Lotus would not apply to these vehicles because
they were manufactured before March 8, 2013.
    Lotus has agreed to pay a civil penalty for alleged violations of
49 USC 30112(a).\2\ Additionally, the Administrator has the authority
to terminate or modify a temporary exemption granted under 49 CFR Part
555 upon a finding that (1) the temporary exemption is no longer
consistent with the public interests and the objectives of the National
Traffic and Motor Vehicle Safety Act; or (2) the temporary exemption
was granted on the basis of false, fraudulent, or misleading
representations or information. At the time the agency granted Lotus
its exemption, the agency believed that Lotus ceased production of the
Evora for the United States market as of September 1, 2012 and was not
aware that Lotus continued to manufacture the Evora after September 1,
2012. On the basis of this incorrect information, NHTSA granted Lotus a
one-year exemption commencing on March 8, 2013.
---------------------------------------------------------------------------

    \2\ Among other things, 49 USC 30112(a) prohibits a person from
selling, offering for sale, introducing or delivering into
interstate commerce, or importing into the United States any motor
vehicle that does not comply with the FMVSSs then in effect.
---------------------------------------------------------------------------

    Having found that Lotus's exemption was based on incorrect
information, the agency has the authority to modify or terminate
Lotus's temporary exemption.\3\ Because the 51 vehicles are identical
to those manufactured prior to September 1, 2012 and those that may be
manufactured under Lotus's temporary exemption, the agency has decided
it is appropriate to modify Lotus's exemption to apply it retroactively
to vehicles manufactured after September 1, 2012 and imported on or
after November 7, 2012. This will allow the exemption to apply to 50 of
the 51 vehicles manufactured after September 1, 2012.\4\ Lotus will
export one vehicle from the United States, which will not be included
in the exemption.
---------------------------------------------------------------------------

    \3\ Lotus has acknowledged that it has been duly notified by
NHTSA of any facts that warrant modifying or terminating its
exemption and that it has had an opportunity to demonstrate or
achieve compliance with all lawful requirements.
    \4\ It is not unprecedented that for NHTSA to apply a temporary
exemption to vehicles that have already been manufactured at the
time of the grant of an exemption. In a March 1995 grant of an
application for a temporary exemption from the air bag requirements
FMVSS No. 208 to Excalibur Automobile Corporation, the agency
applied a temporary exemption to 36 vehicles that were, at the time
of the request for exemption, in control of the company's dealers.
See 60 FR 12281 (Mar. 6, 1995).
---------------------------------------------------------------------------

    The 50 vehicles will count toward the 450 vehicle limit under the
exemption. Because these 50 vehicles are now covered by an exemption,
Lotus must ensure that they are labeled with the correct date of
manufacture and statements required by 49 CFR 555.9 for exempted
vehicles.
    The agency's determination that a one-year exemption is appropriate
under the circumstances has not changed. Thus, in addition to applying
the exemption retroactively to 50 vehicles, the agency has also
modified the termination date of the exemption so that the exemption
granted is not longer than one year. The exemption will now apply to
vehicles manufactured through November 7, 2013.
    Based on the foregoing and pursuant to 49 CFR 555.8(d), the
Administrator finds that NHTSA Temporary Exemption No. EX 13-01,
granted to Lotus from S14.7 of 49 CFR 571.208 for the front passenger
seat of its Evora model was based on incorrect information.
Accordingly, the exemption is modified to include vehicles imported on
or after November 7, 2012. The exemption is also modified to terminate
on November 7, 2013.

    Authority: 49 U.S.C. 30113; 49 CFR 1.95, 555.8.

    Issued in Washington, DC, on June 21, 2013 under authority
delegated in 49 CFR 1.95, 501.5, and 501.7.
David L. Strickland,
Administrator.
[FR Doc. 2013-15534 Filed 6-27-13; 8:45 am]
BILLING CODE 4910-59-P