	Office of Chemical Safety and Pollution Prevention

(7101)	EPA 712-C-16-005

October 2016

	Ecological Effects

Test Guidelines

OCSPP 850.1300:

	Daphnid Chronic Toxicity Test

NOTICE

This guideline is one of a series of test guidelines established by the
United States Environmental Protection Agency’s Office of Chemical
Safety and Pollution Prevention (OCSPP) for use in testing pesticides
and chemical substances to develop data for submission to the Agency
under the Toxic Substances Control Act (TSCA) (15 U.S.C. 2601, et seq.),
the Federal Insecticide, Fungicide and Rodenticide Act (FIFRA) (7 U.S.C.
136, et seq.), and section 408 of the Federal Food, Drug and Cosmetic
Act (FFDCA) (21 U.S.C. 346a). Prior to April 22, 2010, OCSPP was known
as the Office of Prevention, Pesticides and Toxic Substances (OPPTS). To
distinguish these guidelines from guidelines issued by other
organizations, the numbering convention adopted in 1994 specifically
included OPPTS as part of the guideline’s number. Any test guidelines
developed after April 22, 2010 will use the new acronym (OCSPP) in their
title.

	The OCSPP harmonized test guidelines serve as a compendium of accepted
scientific methodologies and protocols that are intended to provide data
to inform regulatory decisions under TSCA, FIFRA, and/or FFDCA. This
document provides guidance for conducting the test, and is also used by
EPA, the public, and the companies that are subject to data submission
requirements under TSCA, FIFRA, and/or the FFDCA. As a guidance
document, these guidelines are not binding on either EPA or any outside
parties, and the EPA may depart from the guidelines where circumstances
warrant and without prior notice. At places in this guidance, the Agency
uses the word “should.” In this guidance, the use of “should”
with regard to an action means that the action is recommended rather
than mandatory. The procedures contained in this guideline are strongly
recommended for generating the data that are the subject of the
guideline, but EPA recognizes that departures may be appropriate in
specific situations. You may propose alternatives to the recommendations
described in these guidelines, and the Agency will assess them for
appropriateness on a case-by-case basis.

	For additional information about these test guidelines and to access
these guidelines electronically, please go to  HYPERLINK
"http://www.epa.gov/ocspp" http://www.epa.gov/ocspp  and select “Test
Methods & Guidelines” on the navigation menu. You may also access the
guidelines in  HYPERLINK "http://www.regulations.gov"
http://www.regulations.gov  grouped by Series under Docket ID #s:
EPA-HQ-OPPT-2009-0150 through EPA-HQ-OPPT-2009-0159, and
EPA-HQ-OPPT-2009-0576.

  SEQ CHAPTER \h \r 1 OCSPP 850.1300: Daphnid chronic toxicity test

(a) Scope.

(1) Applicability. This guideline is intended for use in meeting testing
requirements of the Federal Insecticide, Fungicide, and Rodenticide Act
(FIFRA) (7 U.S.C. 136, et seq.) and the Toxic Substances Control Act
(TSCA) (15 U.S.C. 2601, et seq.). It describes procedures that, if
followed, would result in data that would generally be of scientific
merit for the purposes described in paragraph (b) of this guideline.

― Hazard Evaluation; Wildlife and Aquatic Organisms; see paragraph
(j)(4) of this guideline); Standard Evaluation Procedure: Daphnia magna
Life-Cycle (21-Day Renewal) Chronic Toxicity Test (see paragraph (j)(5)
of this guideline); EPA Pesticide Reregistration Rejection Rate
Analysis: Ecological Effects (see paragraph (j)(6) of this guideline);
OECD 211 Daphnia magna Reproduction Test, 2012 (see paragraph (j)(3) of
this guideline); and ASTM E1193-97, Standard Guide for Conducting
Daphnia magna Life-Cycle Toxicity Tests (see paragraph (j)(1) of this
guideline).

(b) Purpose. This guideline is intended for use in developing data on
the chronic toxicity of chemical substances and mixtures (“test
chemicals” or “test substances”) subject to environmental effects
test regulations. This guideline describes a chronic toxicity test in
which daphnids (Daphnia magna or Daphnia pulex) are exposed to a test
substance in static-renewal or flow-through systems. The Environmental
Protection Agency will use data from this test to assess the hazards and
risks a test substance may present in the aquatic environment.

 (c) Definitions. The definitions in OCSPP 850.1000 apply to this test
guideline. In addition, the following more specific definitions apply to
this test guideline:

Effective concentration, median (EC50) is the experimentally derived
concentration of test substance in dilution water that would be expected
to cause a defined adverse effect in 50 percent (%) of a group of test
organisms under specified exposure conditions. In this guideline, the
effect measured is immobilization as a surrogate for death.

Ephippium is a resting egg that develops in daphnids under the carapace
in response to stress conditions.

Immobilization refers to a lack of movement except for minor
spontaneous, random activity of appendages; those animals that are not
able to swim within 15 seconds after gentle agitation of the test vessel
are considered to be immobilized even if they can still move their
antennae. Immobilization, as defined for this guideline, is used as a
surrogate for death. Dead animals are counted as immobilized.

F0 (Parental generation) are those daphnids (less than (<) 24 hours old)
that are used to begin the test and subsequently develop into adults and
produce offspring during the test.

F1 (Filial generation, first) are the offspring produced by the parental
generation (F0).

(d) General considerations.

(1) Summary of the test. Daphnids are exposed to the test substance and
to appropriate controls (i.e., dilution water control and a vehicle
(solvent) control, if a vehicle is used) for 21 days, during which
observations are made on survival, growth, and reproduction. The results
of the test are used to calculate, at a minimum, the hypothesis-based no
observed effect concentration (NOEC) and the lowest observed effect
concentration (LOEC) for these endpoints. Concentration-response
regression-based models may also be fit, and point estimates (e.g.,
inhibition concentration (ICx) and effect concentration (ECx)) may be
calculated ancillary to NOEC and LOEC determinations where there is
sufficient coverage of the concentration-response curve.

(2) General test guidance. The general guidance in OCSPP 850.1000
applies to this guideline except as specifically noted herein.

(3) Range-finding test. A range-finding test is usually conducted to
establish the appropriate test solution concentrations to be used in the
definitive test. In the range-finding test, the test organisms are
generally exposed to a series of widely-spaced concentrations of the
test substance (e.g., 1, 10, 100 milligrams per liter (mg/L)) for a
period of time that allows estimation of the appropriate chronic test
concentrations. Often chronic range-finding test concentrations are
selected based upon the results of an acute toxicity test. It should be
noted, however, that the presence of food in the chronic test can affect
the results and consequently the predictive ability of the acute test.
The details of the range-finding test do not have to be the same as
those of definitive testing in that the number of replicates, the number
of test organisms, and duration of exposure may be less than that used
in definitive testing. In addition, the types of observations made on
test organisms may not be as detailed or as frequently observed as that
of a definitive test. Results of range-finding tests should be reported
along with the results of the definitive test, if range-finding tests
are conducted.

(4) Definitive test.

(i) The goal of the definitive test is to determine the effects of the
test substance on immobilization, growth, and reproduction during
chronic exposure. The test endpoints are expressed in terms of the
results of hypothesis-based testing (i.e., NOEC and LOEC).
Concentration-response regression-based models may also be fit, and
point estimates (e.g., inhibition concentration (ICx) and effect
concentration (ECx)) may be calculated ancillary to NOEC and LOEC
determinations where there is sufficient coverage of the
concentration-response curve.

(ii) A minimum of 5 concentrations of the test substance, plus
appropriate controls, should be tested. For hypothesis-based testing,
there should be 1 concentration level where no adverse effects occur as
compared to the control(s) and a second, higher concentration with an
adverse effect. For regression-based endpoints, if calculated, the
selected test concentrations, at a minimum, should bracket the desired
median inhibition/effect concentration (ICx/ECx) of the most sensitive
endpoint. Analytical confirmation of dissolved test concentrations
should be performed as described in OCSPP 850.1000. Summaries of the
test conditions are presented in Table 2 of this guideline. Test
validity elements are listed in Table 3.

(5) Limit test. In some situations, it is only necessary to ascertain
that no effects on daphnid survival, growth, or reproduction occur at a
certain limit concentration (i.e., NOEC greater than or equal to (≥)
limit concentration). For guidance on the number of replicates and
organisms to use at the limit concentration, refer to paragraph (e)(6)
in this guideline. For most industrial chemicals, the lower of 10 mg/L
or the limits of water solubility or dispersion is considered
appropriate as the limit concentration. For pesticides, the lower of 10
milligrams active ingredient per liter (mg a.i./L), when estimated
environmental concentrations are not expected to exceed 10 mg/L, or the
limit of water solubility may be used as the limit concentration. Except
for the number of test concentrations, limit tests should follow the
same test procedures, have the same duration as the
multiple-concentration definitive test (see Table 2 of this guideline),
and have both a dilution water control and a vehicle (solvent) control,
if a vehicle is used. Limit tests, like definitive tests, should include
analytical confirmation of the dissolved concentration of the test
substance. If there is a statistically significant inhibition in any of
the response variables in Table 1 at the limit concentration as compared
to the control(s) (i.e., no observed effect concentration (NOEC) less
than (<) limit concentration), a multiple-concentration definitive test
should be conducted.

(e) Test standards.

(1) Test substance. The substance to be tested should be technical or
reagent grade unless the test is designed to test a specific
formulation, mixture, or end-use product. For pesticides, if more than
one active ingredient constitutes a technical product, then the
technical grade of each active ingredient should be tested separately,
in addition to the combination, if applicable. OCSPP 850.1000 lists the
type of information that should be known about the test substance before
testing and discusses methods for preparation of test solutions.

	(2) Test duration. The test duration is 21 days.

	(3) Test organism.

(i) Species. The test species are Daphnia magna or Daphnia pulex. First
instar daphnids, <24 hours old, should be used to start the test.

Daphnids to be used in chronic toxicity tests should be cultured at the
test facility. Records should be kept regarding the source of the
initial stock and culturing techniques. All organisms used for a
particular test should originate from the same culture population that
should have been maintained for at least 21 days in the same conditions
and in the same dilution water source as those used for testing.

(ii) Holding and acclimation. During culturing and acclimation to the
dilution water, stock animals should be maintained in culture conditions
(e.g., temperature, light intensity) similar to those to be used in the
test. Any changes in the temperature and chemistry of the dilution water
used for culturing the test organisms to those of the test should be
gradual, and a group of brood daphnids should be maintained in dilution
water at the test temperature for at least 48 hours prior to the start
of the test. Within a 24-hour period, changes in water temperature
should not exceed 1 degree Celsius (°C).

		(iii) Health status and condition. Daphnids should not be used for a
test:

			(A) If the culture contains ephippia;

(B) If more than 5% of the culture stock dies or shows signs of stress
(e.g., exhibits abnormal behavior) during the 48 hours preceding the
test;

(C) If adults in the culture do not produce offspring before day 12;

(D) If adults in the culture do not produce an average of at least 3
offspring per adult per day over the 7-day period prior to the test;

			(E) If they are first-brood progeny;

(F) If they have been used in a previous test, either in a treatment or
in a control group.

(iv) Care and handling. Organisms should be handled as little as
possible, but when necessary, it should be done as carefully and quickly
as possible. During culturing, holding, and acclimation, daphnids should
be observed carefully for ephippia and other signs of stress, physical
damage, and mortality. Dead and abnormal individuals should be
discarded. Organisms that touch dry surfaces or are dropped or injured
during handling should also be discarded. Smooth glass tubes (inner
diameter greater than (>) 5 millimeters (mm)) equipped with rubber bulbs
have been used in transferring daphnids with minimal culture media
carry-over. Care should be exercised to introduce the daphnids below the
surface of any solution to avoid trapping air under the carapace.

(v) Diet and feeding. During the test, the daphnids should be fed the
same diet as that used for culturing, holding, and acclimation. All
treatments and controls should receive, as near as possible, the same
ration of food on a per-animal basis. The feeding regime should provide
for an acceptable level of reproduction (see Table 3 of this guideline).

Feeding should occur once per day in static-renewal tests, typically
after the test solutions are renewed (on renewal days) and at the same
time on non-renewal days. At least 2 feedings, and preferably 3
feedings, per day are recommended in flow-through tests. Continuous
feeding devices may also be used.

Various combinations of trout chow, yeast, alfalfa, and algae have been
successfully used for culturing and testing daphnids; however, research
has demonstrated that it is best to incorporate algae into the diet to
maintain consistently healthy daphnids (see paragraph (j)(1) of this
guideline). The concentration of food provided depends on the type used.
Food concentrations should be sufficient to support normal growth and
development and to allow for asexual (parthenogenic) reproduction. For
automatic feeding devices, a suggested rate is 5 to 7 mg food (either
solids or algal cells, dry weight) per liter of dilution water or test
solution. For manual once-a-day feeding, a suggested rate is 15 mg food
(dry weight) per liter of dilution water or test solution. Other
recommended feeding regimes include 1 mg/L trout chow suspension
(optional) or 1 x 108 algal cells/L, or both (see paragraph (j)(1) of
this guideline). For D. magna, ration levels between 0.1 and 0.2 mg
organic carbon per daphnid per day should be sufficient for achieving
the number of offspring to meet the test validity elements (see
paragraph (j)(2) of this guideline).

	(4) Administration of test substance.

(i) Preparation of test solutions. Preparation of test solutions depends
on the solubility and stability of the test substance. Guidance for
preparation of test solutions, especially for difficult or low
solubility test substances, is provided in OCSPP 850.1000. Dilution
water source and quality used in the test are described in OCSPP
850.1000 and paragraph (e)(7)(vi) of this guideline.

The concentration of vehicle solvent should not exceed 0.1 milliliters
per liter (mL/L). A previous review recommends that solvent
concentrations as low as 0.02 mL/L of dilution water be used (see
paragraph (j)(2) of this guideline).

The pH of stock solutions may be adjusted to match the pH of dilution
water or to a neutral pH if pH change does not affect the stability of
the test substance in water. The pH of test solutions may be adjusted
after the addition of the test substance or stock solution into the
dilution water. However, all pH adjustments need to be made prior to the
addition of test organisms. Hydrochloric acid (HCl) and sodium hydroxide
(NaOH) may be used for this adjustment if warranted.

See additional information about pH during testing in (e)(8)(ii).

(ii) Exposure technique. The test should be conducted using one of two
basic exposure techniques: static-renewal or flow-through. Guidance on
the selection of the appropriate exposure technique is provided in OCSPP
850.1000.

For a static-renewal test, the frequency of medium renewal will depend
on the stability of the test substance, but should be at least three
times per week with a maximum renewal period of 3 days.

(iii) Treatment concentrations. At least 5 test solution concentrations
should be used for definitive testing, plus the appropriate control(s).
A range-finding test, as well as the EC50 curve in an acute test, may be
used to establish the appropriate test solution concentrations for the
definitive test (see paragraph (d)(3) of this guideline). Justification
should be provided if fewer than 5 concentrations are used. OCSPP
850.1000 provides guidance on selection of test concentrations.

For hypothesis-based testing, there should be 1 concentration level
where no adverse effects occur as compared to the control(s) and a
second, higher concentration with an adverse effect. For
regression-based endpoints, if calculated, the selected test
concentrations, at a minimum, should bracket the desired median
inhibition/effect concentration (ICx/ECx) of the most sensitive
endpoint.

For a limit test, there is a single treatment concentration, plus the
appropriate control(s). Guidance on the limit concentration is provided
in paragraph (d)(5) of this guideline.

(5) Controls. Every test includes a dilution water control and a vehicle
(solvent) control, if a vehicle is used. Controls consist of the same
dilution water, conditions, procedures, and test population as the test
solutions, except that no test substance is added.

	A test is not acceptable if:

(i) More than 20% of the organisms in any control showed signs of
disease, stress (e.g., discoloration, unusual behavior, immobilization),
and/or death; or

		(ii) Ephippia were produced in any control; or

(iii) Daphnids in any control that lived for 21 days did not produce, on
average, at least 60 offspring in the 21 days of the test.

(6) Number of test organisms and replicates. There are 2 test designs
that are commonly used. The first design, which is often used with the
static-renewal exposure technique, employs 10 replicate test vessels,
each with a single daphnid, for each test concentration and control. The
second design, which is often used with the flow-through exposure
technique, employs 4 replicate test vessels, each with 5 daphnids, for
each test concentration and control resulting in a total of 20 daphnids
per test concentration and control. Regardless of the design, each test
vessel should contain an equal volume of test solution and an equal
number of daphnids. Replicate test vessels should be physically
separated, since the test vessel is the experimental unit.

(i) Loading. The number of daphnids placed in a test vessel should not
be so large as to cause the dissolved oxygen concentration to fall below
the recommended levels, the un-ionized ammonia concentration to exceed
the recommended levels, or affect the results of the test. In
static-renewal tests, loading should not exceed 1 daphnid per 40 mL of
test solution (25 daphnids per liter). In flow-through tests, loading
requirements will vary depending upon the flow rate of the dilution
water, but should not exceed 0.5 grams wet weight of organism per liter
(g/L) of solution passing through the test vessel in 24 hours or 5 g/L
at any time.

(ii) Introduction of test organisms. The test should be started by
introducing <24-hour old daphnids, from acclimated parents, into the
test vessels after the test substance has been added. Test vessels for
treatment levels should be randomly or indiscriminately located within
the test area, and test organisms should be randomly or indiscriminately
distributed among test vessels. Further guidance is provided in OCSPP
850.1000.

(7) Facilities, apparatuses, and supplies. Normal laboratory equipment
should be used, especially the following:

(i) Facilities. Facilities for culturing, holding, acclimating, and
testing daphnids that are well ventilated and free of fumes and
disturbances which may affect the test organisms. Equipment for
culturing and/or handling food sources for daphnids. Drying ovens,
aluminum weighing pans, and an analytical balance capable of accurately
weighing to 0.01 mg.

(ii) Environmental control equipment. Mechanisms for controlling and
maintaining the water temperature and lighting during the culturing,
holding, acclimation, and test periods. Apparatus for aerating the
dilution water and removing gas bubbles as necessary. For flow-through
tests, apparatus for aerating the dilution water in the head box before
mixing with the test substance or delivery to test vessels. An apparatus
providing a 30-minute lighting transition period may be needed.

(iii) Water quality testing instruments. Equipment for determination of
water quality characteristics (pH, hardness, temperature, etc.)

(iv) Cleaning of test system. Test substance delivery systems and test
vessels should be cleaned before each test. See OCSPP 850.1000 for
further information. Cleaning of test vessels may be necessary during
the testing period and can be accomplished as described in paragraph
(j)(1). Daily brushing of the outside of the screens (during
flow-through tests) is recommended.

(v) Test containers and delivery system. Construction materials and
equipment that may contact the stock solution, test solution, or
dilution water should not contain substances that can be leached or
dissolved into aqueous solutions in quantities that can affect the test
results. Construction materials and equipment that contact stock or test
solutions should be chosen to minimize sorption of test substances.
Refer to OCSPP 850.1000 for additional information on appropriate
construction materials. Test vessels, which should be constructed of
chemically inert material, should be of a capacity to maintain the
loading rate and environmental conditions. Test vessels should be
loosely covered to reduce the loss of test solution or dilution water
due to evaporation and to minimize the entry of dust or other
particulates into the solutions. The flow-through system, if used,
should contain an appropriate test substance delivery system. In
addition, there should be an apparatus to introduce food if continuous
or intermittent feeding is used.

For flow-through tests, daphnids can be retained in glass or stainless
steel containers (i.e., test compartments) with stainless steel or nylon
screen bottoms within the test vessel. The containers should be
suspended in the test vessel in such a manner as to ensure that the test
solution flows regularly into and out of the container and that the
daphnids are always submerged in at least 5 centimeters (cm) of test
solution.

Test vessels can be constructed using 250-mL beakers or other suitable
containers equipped with screened overflow holes, standpipes, or
V-shaped notches.

(iv) Dilution water. Clean surface water, ground water, or reconstituted
water are acceptable as dilution water if daphnids will survive in it
for the duration of the culturing, holding, acclimation, and testing
periods without showing signs of stress. Dechlorinated tap water is not
recommended because some forms of chlorination are difficult to remove
adequately. If dechlorinated tap water is used, recommended maximum
chlorine levels as well as other ways to demonstrate suitability as a
dilution water source can be found in OCSPP 850.1000. The addition of
selenium and vitamin B12 may also be desirable in reconstituted water
(see paragraph (j)(1) of this guideline). Daphnids may also be cultured
and tested in a defined medium (see paragraph (j)(3) of this guideline).

Dissolved oxygen in the dilution water (prior to use in a test) should
be between 90 and 100% saturation. If necessary, the dilution water can
be aerated before the addition of the test substance.

Hardness, alkalinity, and conductivity should be measured in the
dilution water at the beginning of the test. When using soft water
(40-50 mg/L hardness), the test species should be D. pulex, as D. magna
is intolerant of soft water.

Measurement of total organic carbon (TOC) or chemical oxygen demand
(COD) in the dilution water at the beginning of the test is recommended,
but at a minimum, TOC and COD should be analyzed periodically in the
dilution water source to document and characterize their magnitude and
variability. For tests with cationic substances, TOC or COD should be
measured at the beginning of the test.

Specifications for dilution water quality and constancy are described in
OCSPP 850.1000.

 (8) Environmental conditions. Environmental parameters during the test
should be maintained as specified below. The number and frequency of
measurements recommended for documenting and confirming the magnitude
and variability of water quality parameters (e.g., temperature,
dissolved oxygen, and pH) in test solutions during the test are
described in detail in OCSPP 850.1000.

(i) Temperature. The water temperature should be 20 °C and should be
constant within plus or minus (±) 2 °C during the test.

(ii) pH. The pH should be between 6.0 and 8.5 and vary less than 1 pH
unit during the test within a test vessel and between test
concentrations (including control(s)).

(iii) Lighting and photoperiod. A photoperiod should be selected from
regimes of 12 hours light:12 hours dark to 16 hours light:8 hours dark.
For any given test, the light regime should be constant. Light intensity
should range from 540 to1080 lux (approximately 50-100 foot-candles
(ft-c)). A 15- to 30-minute transition period between light and dark is
suggested.

(iv) Dissolved oxygen. The dissolved oxygen concentration should be
between 60 and 100% saturation during the test. If aeration is needed to
achieve an appropriate dissolved oxygen level, it should be done before
the addition of the test substance. The use of more frequent renewal of
test solutions or a higher flow rate should be used to maintain adequate
dissolved oxygen levels. For flow-through exposures, the dilution water
may be aerated vigorously prior to delivery to the test vessels (e.g.,
in the diluter head box) such that the dissolved oxygen concentration is
at or near 90 to 100% saturation. If the water is heated, precautions
should be taken to ensure that supersaturation of dissolved gases is
avoided. Aeration of test solutions during the test is strongly
discouraged because a single air bubble can become caught under the
carapace of a daphnid and kill it or float the daphnid to the surface
where it will become trapped. Therefore, gentle aeration of test vessels
during the exposure period may only be utilized in cases where the
dissolved oxygen levels are in danger of dropping below 60% saturation.
In such cases, assurances should be made that the use of aeration does
not stress the test organisms; test substance concentrations should be
measured during the test to ensure that they are not affected by the use
of aeration; and all treatment and control vessels should be given the
same aeration treatment.

(v) Flow in a flow-through system. During a test, the flow rates should
not vary more than 10% between any one replicate and another. The
minimum number of test vessel volume replacements should be five per
24-hour period. It is recommended that diluter systems be monitored for
proper adjustment and operation at least twice daily throughout the test
period to better ensure that the target test concentrations are achieved
and maintained. The flow rate to each test vessel should be measured
weekly and at the beginning and end of the test.

	(9) Observations.

(i) Measurement of test substance. OCSPP 850.1000 describes the
recommended sampling methods, frequency of sampling, and sample
processing (especially of low solubility test substances) for analytical
confirmation of dissolved test concentrations and characterization of
test substance stability throughout the test. The analytical methods
used to measure the amount of dissolved test substance in a sample
should be validated before beginning the test, as described in OCSPP
850.1000, and the relevant method detection limit(s) and limit(s) of
quantification should be reported.

(ii) Test solution appearance. Observations on test solution appearance
and test substance solubility should be made daily and at the beginning
and end of the test. The appearance of surface slicks, precipitates, or
material adhering to the sides of the test vessels or in any part of the
mixing and delivery system should be recorded at a minimum at the
beginning and end of the test and during the test when the test solution
appearance changes.

(iii) Measures of effect.

(A) F0 survival. During the test, daphnids in the test vessels should be
observed periodically, preferably daily, but at least 3 times per week.
The number of surviving, immobilized, and dead parental (F0) daphnids
should be counted and recorded. Immobilized daphnids should be removed
from test vessels at the time of observation.

(B) Time to release of first brood. The time of appearance of the first
brood in each test vessel should be recorded.

(C) Live offspring produced. Live offspring (F1) should be counted and
removed, preferably daily, but at least 3 times per week, beginning with
the appearance of the first brood.

(D) Number of aborted eggs or immobilized offspring. Only the number of
living offspring is used to calculate the reproductive output for the
test, but the presence of aborted eggs and immobilized or dead offspring
should also be counted and recorded.

. Constant dry weight can be achieved by exposing daphnids to 60 C
for 72 hours or 100 °C for 24 hours. Length is defined as the distance
from the apex of the helmet to the base of the spine or is extrapolated
from a standard curve of dry weight of a test animal to body length.
Since measuring dry weight is a destructive process, lengths should be
taken before the animals are dried.

(F) Appearance and behavior. Observation of any abnormal behavior or
appearance including the presence of males, ephippia, or aborted broods
should be recorded, preferably daily, but at least 3 times per week.

(f) Treatment of results.

(1) Response variable calculations. Response variables calculated from
primary data include proportion of surviving F0 adults, F0 production
rate of first brood release, reproductive output as total number of live
offspring per surviving F0 adult and number of live offspring per F0
adult per reproductive day, and mean surviving F0 adult dry wieght
and/or length and are discussed in paragraphs (f)(1)(i) through
(f)(1)(v) of this guideline.

(i) Proportion of surviving F0 adults. The proportion of surviving F0
adults at test termination for a given replicate is calculated using
Equation 1 of this guideline.

 	Equation 1

where:

 = proportion of surviving F0 adults at test termination in the
replicate;

 = number of surviving F0 adults at test termination in the replicate;
and

N = number of F0 adults at test initiation in the replicate.

(ii) F0 production rate of first brood. The time or rate of F0
production of the first brood (rb) for a given replicate is calculated
using Equation 2 of this guideline.

 	Equation 2

where:

  = F0 production rate of first brood;

i = index of observation events from 1 (first observation event after
test initiation) through m;

ti = time, in days, from test initiation to the first observation event
offspring (F1) were observed in the replicate; and

li = length of observation interval i, in days (if inspected daily, the
length of the inspection interval is 1 day).

(iii) Reproductive output. Reproductive output is expressed in terms of
the total number of live offspring per surviving F0 adult (see paragraph
(f)(1)(iii)(A) of this guideline) and the number of live offspring per
F0 adult per reproductive day (see paragraph (f)(1)(iii)(B) of this
guideline).

 ) for a given replicate is calculated using Equation 3.

 	Equation 3

where:

 = total number of live offspring per surviving F0 adult;

 ; and

 = number of surviving F0 adults at test termination in the replicate.

(B) Number of live offspring per F0 adult per reproductive day. The
number of live offspring per F0 adult per reproductive day (Rb) for a
given replicate is calculated using Equation 4. The number of
reproductive days is the total number of days an F0 adult was observed
alive in a replicate starting from the first day offspring were observed
in the test, irrespective of treatment or replicate. When observations
are not made daily, the number of reproductive days is the average
between the last observation day the F0 adult was observed alive and the
first observation day it was observed dead. When the test design
consists of a single F0 adult per replicate and observations are made
daily, Rb is calculated as the total number of live offspring produced
divided by the total number of reproductive days. When the test design
consists of multiple F0 adults in a replicate and one F0 adult (or more)
dies before the end of the test, the number of days an F0 adult
reproduced from the first day offspring were observed in the test is the
average of the last observation day the F0 adult was observed alive and
the first observation day it was observed dead (see Equation 5 of this
guideline). The value for reproduction days for a given replicate is
calculated by summing the number of F0 adults alive in the replicate for
each reproduction day. These data are available from the daily survival
data. An F0 adult is considered dead for the whole 24 hours preceding
observed death. For example, if an F0 adult is observed dead on day 21,
then that replicate would have one less F0 adult reproduction day.

 	Equation 4

where:

 = number of live offspring per F0 adult per reproductive day;

y = total number of live offspring produced in the replicate; and

f = total number of reproductive days at test termination for the
replicate calculated using Equation 5.

 	Equation 5

where:

i = index of observation events from FBR through m;

FBR = observation event that the first brood release occurred in the
test, irrespective of treatment or replicate;

m = maximum number of observation events;

fi = number of live F0 adults at observation event i; and

li = length of observation interval i, in days (if inspected daily, the
length of the inspection interval is 1 day).

  is the mean surviving F0 adult dry weight.

 	Equation 6

where:

  = mean surviving F0 adult dry weight;

w = dry weight of surviving F0 adult or pooled surviving F0 adults, if
replicate consists of multiple F0 adults, for the replicate (measured as
described in paragraph (e)(9)(iii)(E) of this guideline); and

  = number of surviving F0 adults that were weighed at test termination
in the replicate.

  is the mean surviving F0 adult body length.

 	Equation 7

where:

 = mean surviving F0 adult body length.

 ;

Lk = body length of individual k in the replicate (measured as described
in paragraph (e)(9)(iii)(E) of this guideline); and

 = number of surviving F0 adults that were measured at test termination
in the replicate.

	(2) Summary statistics.

(i) Response variables. For each test group, including the control(s),
summary statistics (mean, median, minimum, maximum, and the first and
third quartiles) for each response variable in Table 1 should be
calculated and plotted. Additionally, the standard deviation,
coefficient of variation, standard error of the mean, and 95% confidence
interval of the mean for each test group, including the control(s),
should be calculated.

(ii) Abnormal appearance. The occurrence (number or proportion is
desired) in F0 adults or offspring (alive or dead) of abnormality of
body form, males, and ephippia should be summarized by type of
abnormality, time of observation, treatment group, and replicate.

(iii) Abnormal behavior. Behavioral abnormalities (e.g., erratic
swimming, atypical quiescence, atypical feeding behavior, immobilized
offspring) should be summarized by type of behavior, time of
observation, treatment group, and replicate.

(3) Percent inhibition. For all response variables in Table 1, the
percent inhibition (%I) as compared to the control(s) for each test
substance treatment level is calculated using Equation 8.

 	Equation 8

where:

%I = percent inhibition as compared to the control(s);

C = mean control response value (e.g., mean F0 production rate of first
brood); and

X = mean response value (e.g., mean F0 production rate of first brood)
for test substance treatment level.

Stimulation or a greater response in the test substance treatment than
the control(s) is reported as negative %I.

(4) Evaluation of limit test results. At test termination (21 days), if
there is a statistically significant inhibition in any of the response
variables in Table 1 at the limit concentration as compared to the
control(s), a multiple-concentration definitive test should be
conducted.

	(5) Evaluation of multiple-concentration definitive test.

(i) NOEC. A NOEC and a LOEC should be determined for each of the
response variables in Table 1 using appropriate statistical methods.
Involvement of a statistician in both the design and analysis of the
test results is recommended since OCSPP 850.1300 allows for variation in
experimental design (e.g., number of test animals per replicate, number
of replicates). The overall NOEC and LOEC values for the test are the
lowest values (i.e., most sensitive) of all the response variables
considered.

(ii) Regression-based endpoints. The test should be conducted to obtain
hypothesis-based endpoints (see paragraph (f)(5)(i) of this guideline).
Ancillary to NOEC and LOEC determinations, the LCx for survival and the
ECx/ICx for growth (length and weight) may be estimated when there is
sufficient coverage of the concentration-response curve.

(iii) Statistical methods. All methods used for statistical analysis
should be described completely. Experimental units (replicates) are the
individual test vessels within each treatment level. Additional
discussion about endpoints and statistical procedures can be found in
OCSPP 850.1000.

―Test Response Variables to Calculate and Evaluate

 )

(g) Tabular summary of test conditions. Table 2 lists the important
conditions that should prevail during the multiple-concentration
definitive test. The same conditions are recommended for a limit test,
except for the difference in the number of test concentrations. Meeting
these test conditions will help ensure the satisfactory performance of
the test.

	Table 2.―Summary of Test Conditions for Daphnid Chronic Toxicity Test

≤2 mg/L

Renewal of test solutions	Static-renewal test: minimum of 3 times per
week with a maximum renewal period of 3 days;

≤0.1 mL/L for recommended solvents (see OCSPP 850.1000)

Test concentrations	Definitive test: minimum of 5 test concentrations
chosen in a geometric series plus a dilution water control and a vehicle
(solvent) control, if a vehicle is used

Measures of effect or measurement endpoints	Definitive test: NOEC/LOEC
for response parameters in Table 1

(h) Test validity elements. This test would be considered to be
unacceptable or invalid if one or more of the conditions in Table 3
occurred. These parameters are not the only elements considered when
evaluating the acceptability of a test, and it is possible that a test
could be found unacceptable or invalid based on other considerations.
However, except for the conditions listed in Table 2 and in OCSPP
850.1000, it is unlikely that a test will be rejected when there are
only slight variations from guideline environmental conditions and test
design unless the control organisms are significantly affected and/or
significant biases are introduced in defining the magnitude of effect on
measurement endpoints as compared to guideline conditions. Before
departing significantly from this guideline, the investigator should
contact the Agency to discuss the reason for the departure and the
effect the change(s) may have on test acceptability. In the test report,
all departures from the guideline should be identified, reasons for the
changes given, and any resulting effects on test endpoints noted and
discussed.

	Table 3.―Test Validity Elements for the Daphnid Chronic Toxicity Test

1. All test vessels were not identical.

2. Treatments were not randomly or indiscriminately assigned to
individual test vessel locations, or individual test organisms were not
randomly or indiscriminately assigned to test vessels.

3. A dilution water control (and vehicle (solvent) control, if a vehicle
was used) was not included in the test.

4. The test was begun with daphnids more than 24 hours old.

5. More than 20% of the organisms in either the dilution water or
vehicle (solvent) controls showed signs of disease, stress (e.g.,
discoloration, unusual behavior, immobilization), and/or death.

6. Daphnids that lived for 21 days in any control did not produce, on
average, at least 60 offspring in the 21 days.

7. Ephippia were produced in the control(s).

8. A surfactant or dispersant was used in the preparation of a stock or
test solution. (However, adjuvants may be used when testing pesticide
typical end-use products.)

(i) Reporting.

(1) Background information. Paragraph (k)(1) of OCSPP 850.1000 describes
the minimum background information to be supplied in the report.

(2) Guideline deviations. Provide a statement of the guideline or
protocol followed. Include a description of any deviations from the test
guideline or any occurrences which may have influenced the results of
the test, the reasons for these changes, and any resulting effects on
test endpoints noted and discussed.

	(3) Test substance.

(i) Identification of the test substance: common name, IUPAC and CAS
names, CAS number, structural formula, source, lot or batch number,
chemical state or form of the test substance, purity (i.e., for
pesticides, the identity and concentration of active ingredient(s)), and
radiolabeling, if any, including the location of label(s) and
radiopurity.

(ii) Storage conditions of the test chemical or test substance and
stability of the test chemical or test substance under storage
conditions if stored prior to use.

(iii) Methods of preparation of the test substance and the treatment
concentrations used in the range-finding and definitive tests, or limit
test. Identify whether the nominal concentrations are corrected or
uncorrected for purity of the test substance.

(iv) Physicochemical properties of the test substance such as water
solubility, vapor pressure, UV absorption, pKa, and Kow.

(v) If a vehicle (solvent) is used to prepare stock or test substance,
provide the name and source of the vehicle, the nominal concentration(s)
of the test substance in the vehicle in stock solutions or mixtures, and
the vehicle concentration(s) used in the treatments and vehicle control.
If different vehicle concentrations are used at different treatment
levels, the report should, at a minimum, identify the maximum vehicle
concentration used. It is helpful to support the vehicle choice by
including a description of any measures that were taken to identify an
appropriate vehicle for use in the test, such as the types and
concentrations of vehicles used and their corresponding effects on
solubility during any preliminary work.

(vi) If a positive control is used, provide the name and source of
positive control and the nominal concentration(s) of the positive
control material in stock solutions or mixtures.

	(4) Test organisms.

(i) Scientific name and common name.

		(ii) Method for verifying the species.

(iii) Information about the daphnids used as brood stock in the test:
source, culture practices, and holding and acclimation procedures and
conditions, including acclimation period, water used, feeding history,
and health status (mortality of brood stock before test initiation and
any preventative or disease treatments).

		(iv) Age of test organisms at test initiation.

(5) Test system and conditions. Provide a description of the test system
and conditions used in the definitive or limit test and any preliminary
range-finding tests.

(i) Description of range-finding test, if any: test concentrations,
other relevant conditions, and results from test that were used to
determine conditions for the definitive test.

(ii) Description of the test vessels: size, type, material, and fill
volume.

(iii) Description of the exposure technique: static-renewal,
flow-through, open or closed system. If static-renewal, the frequency of
test solution renewal, and if flow-through, a description of the
flow-through system, including flow rates and test vessel turnover rate.
For closed systems, a description of the closed system design. For all
systems, a description of the calibration and validation methods.

(iv) Description of the dilution water and any water pretreatment:
source/type; temperature; pH; hardness and alkalinity; dissolved oxygen;
total organic carbon or chemical oxygen demand; particulate matter;
conductivity; metals, pesticides, and residual chlorine concentrations
(mean, standard deviation, range). If natural water, also provide the
un-ionized ammonia concentration. Describe the frequency and sample
date(s) for documenting dilution water quality and consistency.

(v) Use of aeration, if any, and location of aeration within exposure
system (e.g., test solution or dilution water prior to test substance
addition).

		(vi) Number of test organisms added to each test vessel at test
initiation.

		(vii) Number of test vessels (replicates) per treatment level and
control(s).

(viii) Methods used for treatment randomization and assignment of test
organisms to test vessels.

		(ix) Date of introduction of test organisms to test solutions and test
duration.

		(x) Loading rate.

		(xi) Photoperiod and light source.

(xii) Methods and frequency of environmental monitoring performed during
the definitive or limit test for test solution temperature, dissolved
oxygen, pH, light intensity, and ammonia.

(xiii) Methods and frequency of measuring dissolved test substance to
confirm exposure concentrations.

(xiv) Methods and frequency of counting number of immobilized daphnids
and measuring any other toxic symptoms.

(xv) Detailed information on feeding (e.g., type of feed, source, amount
given, and frequency). Feed should be analyzed periodically to identify
background contaminants such as heavy metals (e.g., arsenic, cadmium,
lead, mercury, and selenium) and persistent pesticides, especially
chlorinated insecticides.

(xvi) For definitive and limit tests, description of all analytical
procedures, accuracy of the method, method detection limit, and limit of
quantification.

 	(6) Results.

(i) Nominal exposure concentrations and a tabulation of test substance
analytical results by treatment group and test vessel (provide raw
data), descriptive statistics (mean, standard deviation, minimum,
maximum, coefficient of variation), and percent of nominal.

(ii) Environmental monitoring data results (test solution temperature,
dissolved oxygen, pH, light intensity, and ammonia) in tabular form
(provide raw data for measurements not made on a continuous basis) and
descriptive statistics (mean, standard deviation, minimum, maximum).

(iii) For preliminary range-finding test, if conducted, a tabulation of
the effects monitored by treatment level. Describe findings and use in
setting definitive test exposure concentrations. If information from
other tests such as acute test results was used to set definitive test
exposure concentrations, provide a description.

(iv) For limit test, a tabulation of the number of surviving and
immobilized F0 adults and the number of live offspring counted and
removed in each test vessel, for the limit concentration and control(s),
at each observation time (provide the raw data) and descriptive
statistics (mean, standard deviation, minimum, maximum).

(v) For definitive test, a tabulation of the number of surviving and
immobilized F0 adults and the number of live offspring counted and
removed in each test vessels, for all treatment levels and control(s),
at each observation time (provide the raw data) and descriptive
statistics (mean, standard deviation, minimum, maximum).

		(vi) Time (days) to first brood release.

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as compared to control(s). Provide sufficient raw data for performance
of an independent statistical analysis.

(viii) For limit and definitive tests, a description and tabulation of
abnormal appearance and behavioral signs of toxicity by test vessel,
treatment, and observation time (provide raw data).

(ix) For limit test, provide findings of hypothesis tests for each
response variable and for abnormal behavior and appearance as compared
to the control(s).

(x) For definitive test, a tabulation of NOEC and LOEC determinations
for each response variable and a description of statistical method(s)
used for the NOEC and LOEC determinations, including the software
package, and the basis for the choice of method.

(xi) When appropriate, a description of statistical method(s) used for
point estimates, including the software package for determining EC50
values and fitting the concentration-response model, and the basis for
the choice of method. Provide results of any goodness-of-fit tests.

(j) References. The following references should be consulted for
additional background material on this test guideline.

(1) American Society for Testing and Materials. ASTM E1193-97, Standard
Guide for Conducting Daphnia magna Life-Cycle Toxicity Tests. In Annual
Book of ASTM Standards, Vol. 11.06, ASTM, West Conshohocken, PA. Current
edition approved April 1, 2004.

(2) Hutchinson, T.H., N. Shillabeer, M.J. Winter and D.B. Pickford,
2006. Acute and chronic effects of carrier solvents in aquatic
organisms: A critical review. Aquatic Toxicology, 76, 69-92.

(3) Organization for Economic Cooperation and Development, 2012. OECD
Guidelines for Testing of Chemicals, Guideline 211, Daphnia magna
Reproduction Test.

(4) U.S. Environmental Protection Agency, 1982. Pesticide Assessment
Guidelines, Subdivision E, Hazard Evaluation, Wildlife and Aquatic
Organisms, EPA 540/09-82-024, U.S. Environmental Protection Agency,
Washington, DC.

(5) U.S. Environmental Protection Agency, 1986. Hazard Evaluation
Division Standard Evaluation Procedure: Daphnia magna Life-Cycle (21-Day
Renewal) Chronic Toxicity Test, EPA-540/9-86-144, Office of Pesticide
Programs, Office of Prevention, Pesticides and Toxic Substances, U.S.
Environmental Protection Agency, Washington DC.

(6) U.S. Environmental Protection Agency, 1994. Pesticides
Reregistration Rejection Rate Analysis: Ecological Effects, EPA
738-R-94-035, Office of Prevention, Pesticides and Toxic Substances,
December, 1994.

  PAGE   \* MERGEFORMAT  2

  PAGE   \* MERGEFORMAT  i

  PAGE   \* MERGEFORMAT  1


[Federal Register Volume 87, Number 242 (Monday, December 19, 2022)]
[Rules and Regulations]
[Pages 77502-77505]
[FR Doc No: 2022-27403]

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

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2022-1576; Project Identifier MCAI-2022-01183-T;
Amendment 39-22277; AD 2022-25-21]
RIN 2120-AA64

Airworthiness Directives; Airbus SAS Airplanes

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final rule; request for comments.

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

SUMMARY: The FAA is adopting a new airworthiness directive (AD) for
certain Airbus SAS Model A350-1041 airplanes. This AD was prompted by a
report of a loud noise and vibration in the belly fairing (BF) access
panel above the wings. This AD requires a one-time detailed inspection
of the BF access panels and, depending on findings, accomplishment of
applicable corrective actions, as specified in a European Union
Aviation Safety Agency (EASA) AD, which is incorporated by reference
(IBR). The FAA is issuing this AD to address the unsafe condition on
these products.

DATES: This AD becomes effective January 3, 2023.
    The Director of the Federal Register approved the incorporation by
reference of certain publications listed in this AD as of January 3,
2023.
    The FAA must receive comments on this AD by February 2, 2023.

ADDRESSES: You may send comments, using the procedures found in 14 CFR
11.43 and 11.45, by any of the following methods:
     Federal eRulemaking Portal: Go to regulations.gov. Follow
the instructions for submitting comments.
     Fax:<PHONE_NUMBER>.
     Mail: U.S. Department of Transportation, Docket
Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New
Jersey Avenue SE, Washington, DC 20590.
     Hand Delivery: Deliver to Mail address above between 9
a.m. and 5 p.m., Monday through Friday, except Federal holidays.
    AD Docket: You may examine the AD docket at regulations.gov under
Docket No. FAA-2022-1576; or in person at Docket Operations between 9
a.m. and 5 p.m., Monday through Friday, except Federal holidays. The AD
docket contains this final rule, the mandatory continuing airworthiness
information (MCAI), any comments received, and other information. The
street address for Docket Operations is listed above.
    Material Incorporated by Reference:
     For EASA material incorporated by reference in this AD,
contact EASA, Konrad-Adenauer-Ufer 3, 50668 Cologne, Germany; telephone
+49 221 8999 000; email [email protected]; website easa.europa.eu. You
may find this material on the EASA website at ad.easa.europa.eu.
     For Airbus service information identified in this final
rule, contact Airbus SAS, Airworthiness Office--EAL, Rond-Point Emile
Dewoitine No: 2, 31700 Blagnac Cedex, France; telephone +33 5 61 93 36
96; fax +33 5 61 93 45 80; email airbus.com">[email protected]airbus.com; websiteairbus.com.
     You may view this service information at the FAA,
Airworthiness Products Section, Operational Safety Branch, 2200 South
216th St., Des Moines, WA. For information on the availability of this
material at the FAA, call<PHONE_NUMBER>. It is also available at
regulations.gov under Docket No. FAA-2022-1576.

FOR FURTHER INFORMATION CONTACT: Dat Le, Aerospace Engineer, Large
Aircraft

Section, FAA, International Validation Branch, 2200 South 216th St.,
Des Moines, WA 98198; telephone<PHONE_NUMBER>; email [email protected].

SUPPLEMENTARY INFORMATION:

Comments Invited

    The FAA invites you to send any written data, views, or arguments
about this final rule. Send your comments to an address listed under
ADDRESSES. Include ``Docket No. FAA-2022-1576; Project Identifier MCAI-
2022-01183-T'' at the beginning of your comments. The most helpful
comments reference a specific portion of the final rule, explain the
reason for any recommended change, and include supporting data. The FAA
will consider all comments received by the closing date and may amend
this final rule because of those comments.
    Except for Confidential Business Information (CBI) as described in
the following paragraph, and other information as described in 14 CFR
11.35, the FAA will post all comments received, without change, to
regulations.gov, including any personal information you provide. The
agency will also post a report summarizing each substantive verbal
contact received about this final rule.

Confidential Business Information

    CBI is commercial or financial information that is both customarily
and actually treated as private by its owner. Under the Freedom of
Information Act (FOIA) (5 U.S.C. 552), CBI is exempt from public
disclosure. If your comments responsive to this AD contain commercial
or financial information that is customarily treated as private, that
you actually treat as private, and that is relevant or responsive to
this AD, it is important that you clearly designate the submitted
comments as CBI. Please mark each page of your submission containing
CBI as ``PROPIN.'' The FAA will treat such marked submissions as
confidential under the FOIA, and they will not be placed in the public
docket of this AD. Submissions containing CBI should be sent to Dat Le,
Aerospace Engineer, Large Aircraft Section, FAA, International
Validation Branch, 2200 South 216th St., Des Moines, WA 98198;
telephone<PHONE_NUMBER>; email [email protected]. Any commentary that the
FAA receives which is not specifically designated as CBI will be placed
in the public docket for this rulemaking.

Background

    EASA, which is the Technical Agent for the Member States of the
European Union, has issued EASA AD 2022-0183, dated August 30, 2022
(EASA AD 2022-0183) (also referred to as the MCAI), to correct an
unsafe condition for certain Airbus SAS Model A350-1041 airplanes. The
MCAI states that a loud noise and vibration in the BF area above the
wings was reported. The subsequent inspection revealed missing
fasteners on the upper fastener line at the sewing angle attachment of
the BF access panel 196ET. Further investigation determined that a
shorter fastener and inappropriate self-locking nuts may have been used
to install affected BF access panels on the final assembly line
resulting in not enough threads of the collar engaged to ensure the
locking capability. This condition, if not detected and corrected,
could lead to in-flight detachment of an affected BF access panel,
possibly resulting in damage to, and reduced control of, the airplane.
Airbus SAS has developed a new production modification (116929) to
introduce different self-locking nuts for the affected BF access
panels, increasing the design robustness. EASA AD 2022-0183 requires a
one-time detailed inspection of the affected BF access panels and,
depending on findings, accomplishment of applicable corrective actions.
    The FAA is issuing this AD to address the unsafe condition on these
products. You may examine the MCAI in the AD docket at regulations.gov
under Docket No. FAA-2022-1576.

Related Service Information Under 1 CFR Part 51

    EASA AD 2022-0183 requires a one-time detailed inspection of the
affected BF access panels for loose or missing fasteners, and a
detailed inspection of the bolts attached to the sewing angle of the BF
access panel to confirm that the chamfer length of the bolt is fully
extended through the nut. Depending on the inspection results, EASA AD
2022-0183 requires accomplishment of applicable corrective actions
including installing new or missing fasteners, applying torque,
replacing bolts, and repair.
    The FAA reviewed Airbus Service Bulletin A350-53-P073, dated June
9, 2022, which specifies serial numbers of affected airplanes.
    This material is reasonably available because the interested
parties have access to it through their normal course of business or by
the means identified in the ADDRESSES section.

FAA's Determination

    This product has been approved by the aviation authority of another
country and is approved for operation in the United States. Pursuant to
the FAA's bilateral agreement with this State of Design Authority, it
has notified the FAA of the unsafe condition described in the MCAI
described above. The FAA is issuing this AD after determining that the
unsafe condition described previously is likely to exist or develop on
other products of the same type design.

Requirements of This AD

    This AD requires accomplishing the actions specified in EASA AD
2022-0183 described previously, except for any differences identified
as exceptions in the regulatory text of this AD.

Explanation of Required Compliance Information

    In the FAA's ongoing efforts to improve the efficiency of the AD
process, the FAA developed a process to use some civil aviation
authority (CAA) ADs as the primary source of information for compliance
with requirements for corresponding FAA ADs. The FAA has been
coordinating this process with manufacturers and CAAs. As a result,
EASA AD 2022-0183 is incorporated by reference in this AD. This AD
requires compliance with EASA AD 2022-0183 in its entirety through that
incorporation, except for any differences identified as exceptions in
the regulatory text of this AD. Using common terms that are the same as
the heading of a particular section in EASA AD 2022-0183 does not mean
that operators need comply only with that section. For example, where
the AD requirement refers to ``all required actions and compliance
times,'' compliance with this AD requirement is not limited to the
section titled ``Required Action(s) and Compliance Time(s)'' in EASA AD
2022-0183. Service information required by EASA AD 2022-0183 for
compliance will be available at regulations.gov under Docket No. FAA-
2022-1576 after this AD is published.

FAA's Justification and Determination of the Effective Date

    Section 553(b)(3)(B) of the Administrative Procedure Act (APA) (5
U.S.C. 551 et seq.) authorizes agencies to dispense with notice and
comment procedures for rules when the agency, for ``good cause,'' finds
that those procedures are ``impracticable, unnecessary, or contrary to
the public interest.'' Under this section, an agency, upon finding good
cause, may issue a final rule without providing notice and seeking
comment prior to issuance. Further, section 553(d) of the APA
authorizes agencies to make rules

effective in less than thirty days, upon a finding of good cause.
    There are currently no domestic operators of these products.
Accordingly, notice and opportunity for prior public comment are
unnecessary, pursuant to 5 U.S.C. 553(b)(3)(B). In addition, for the
forgoing reason(s), the FAA finds that good cause exists pursuant to 5
U.S.C. 553(d) for making this amendment effective in less than 30 days.

Regulatory Flexibility Act (RFA)

    The requirements of the RFA do not apply when an agency finds good
cause pursuant to 5 U.S.C. 553 to adopt a rule without prior notice and
comment. Because the FAA has determined that it has good cause to adopt
this rule without notice and comment, RFA analysis is not required.

Costs of Compliance

    Currently, there are no affected U.S.-registered airplanes. If an
affected airplane is imported and placed on the U.S. Register in the
future, the FAA provides the following cost estimates to comply with
this AD:

                  Estimated Costs for Required Actions
------------------------------------------------------------------------
                                                             Cost per
              Labor cost                   Parts cost        product
------------------------------------------------------------------------
6 work-hours x $85 per hour = $595....              $0             $595
------------------------------------------------------------------------

    The FAA estimates the following costs to do any necessary on-
condition installations, replacements, or torqueing that would be
required based on the results of any required actions. The FAA has no
way of determining the number of aircraft that might need these on-
condition actions:

                 Estimated Costs of On-Condition Actions
------------------------------------------------------------------------
            Labor cost                Parts cost      Cost per product
------------------------------------------------------------------------
1 work-hour x $85 per hour = $85..              $3  $88 (per fastener or
                                                     bolt).
------------------------------------------------------------------------

    The FAA has received no definitive data on which to base the cost
estimates the on-condition repairs specified in this AD.
    According to the manufacturer, some or all of the costs of this AD
may be covered under warranty, thereby reducing the cost impact on
affected operators. The FAA does not control warranty coverage for
affected operators. As a result, the FAA has included all known costs
in the cost estimate.

Authority for This Rulemaking

    Title 49 of the United States Code specifies the FAA's authority to
issue rules on aviation safety. Subtitle I, section 106, describes the
authority of the FAA Administrator. Subtitle VII: Aviation Programs,
describes in more detail the scope of the Agency's authority.
    The FAA is issuing this rulemaking under the authority described in
Subtitle VII, Part A, Subpart III, Section 44701: General requirements.
Under that section, Congress charges the FAA with promoting safe flight
of civil aircraft in air commerce by prescribing regulations for
practices, methods, and procedures the Administrator finds necessary
for safety in air commerce. This regulation is within the scope of that
authority because it addresses an unsafe condition that is likely to
exist or develop on products identified in this rulemaking action.

Regulatory Findings

    This AD will not have federalism implications under Executive Order
13132. This AD will not have a substantial direct effect on the States,
on the relationship between the national government and the States, or
on the distribution of power and responsibilities among the various
levels of government.
    For the reasons discussed above, I certify that this AD:
    (1) Is not a ``significant regulatory action'' under Executive
Order 12866, and
    (2) Will not affect intrastate aviation in Alaska.
    (3) Will not have a significant economic impact, positive or
negative, on a substantial number of small entities under the criteria
of the Regulatory Flexibility Act.

List of Subjects in 14 CFR Part 39

    Air transportation, Aircraft, Aviation safety, Incorporation by
reference, Safety.

The Amendment

    Accordingly, under the authority delegated to me by the
Administrator, the FAA amends 14 CFR part 39 as follows:

PART 39--AIRWORTHINESS DIRECTIVES

0
1. The authority citation for part 39 continues to read as follows:

    Authority:  49 U.S.C. 106(g), 40113, 44701.

Sec.  39.13  [Amended]

0
2. The FAA amends Sec.  39.13 by adding the following new airworthiness
directive:

2022-25-21 Airbus SAS: Amendment 39-22277; Docket No. FAA-2022-1576;
Project Identifier MCAI-2022-01183-T.

(a) Effective Date

    This airworthiness directive (AD) is effective January 3, 2023.

(b) Affected ADs

    None.

(c) Applicability

    This AD applies to Airbus SAS Model A350-1041 airplanes,
certificated in any category, having serial numbers identified in
Airbus Service Bulletin A350-53-P073, dated June 9, 2022.

(d) Subject

    Air Transport Association (ATA) of America Code: 53, Fuselage.

(e) Unsafe Condition

    This AD was prompted by a report of a loud noise and vibration
in the belly fairing (BF) access panel above the wings. The FAA is
issuing this AD to address missing fasteners on the BF access panels
due to the use of shorter fasteners and inappropriate self-locking
nuts resulting in not enough threads of the collar engaged to ensure
the locking capability. The unsafe condition, if not addressed,
could result in an in-flight detachment of an affected BF access
panel, possibly resulting in damage to, and reduced control of, the
airplane.

(f) Compliance

    Comply with this AD within the compliance times specified,
unless already done.

(g) Requirements

    Except as specified in paragraph (h) of this AD: Comply with all
required actions and compliance times specified in, and in
accordance with, European Union Aviation Safety Agency (EASA) AD
2022-0183, dated August 30, 2022 (EASA AD 2022-0183).

(h) Exceptions to EASA AD 2022-0183

    (1) Where EASA AD 2022-0183 refers to its effective date, this
AD requires using the effective date of this AD.
    (2) Where the service information referenced in EASA AD 2022-
0183 specifies to do certain actions ``in accordance with the IPD,''
for this AD replace the text ``in accordance with'' with ``refer
to.''
    (3) Where paragraph (2) of EASA AD 2022-0183 refers to a
``defect,'' for purposes of this AD, a defect includes a loose or
missing fastener, and a bolt whose length does not fully extend
through the nut.
    (4) The ``Remarks'' section of EASA AD 2022-0183 does not apply
to this AD.

(i) No Reporting Requirement

    Although the service information referenced in EASA AD 2022-0183
specifies to submit certain information to the manufacturer, this AD
does not include that requirement.

(j) Additional AD Provisions

    The following provisions also apply to this AD:
    (1) Alternative Methods of Compliance (AMOCs): The Manager,
International Validation Branch, FAA, has the authority to approve
AMOCs for this AD, if requested using the procedures found in 14 CFR
39.19. In accordance with 14 CFR 39.19, send your request to your
principal inspector or responsible Flight Standards Office, as
appropriate. If sending information directly to the manager of the
certification office, send it to the attention of the person
identified in paragraph (k) of this AD. Information may be emailed
to: [email protected]. Before using any approved AMOC,
notify your appropriate principal inspector, or lacking a principal
inspector, the manager of the responsible Flight Standards Office.
    (2) Contacting the Manufacturer: For any requirement in this AD
to obtain instructions from a manufacturer, the instructions must be
accomplished using a method approved by the Manager, International
Validation Branch, FAA; or EASA; or Airbus SAS's EASA Design
Organization Approval (DOA). If approved by the DOA, the approval
must include the DOA-authorized signature.
    (3) Required for Compliance (RC): Except as required by
paragraph (j)(2) of this AD, if any service information contains
procedures or tests that are identified as RC, those procedures and
tests must be done to comply with this AD; any procedures or tests
that are not identified as RC are recommended. Those procedures and
tests that are not identified as RC may be deviated from using
accepted methods in accordance with the operator's maintenance or
inspection program without obtaining approval of an AMOC, provided
the procedures and tests identified as RC can be done and the
airplane can be put back in an airworthy condition. Any
substitutions or changes to procedures or tests identified as RC
require approval of an AMOC.

(k) Additional Information

    For more information about this AD, contact Dat Le, Aerospace
Engineer, Large Aircraft Section, FAA, International Validation
Branch, 2200 South 216th St., Des Moines, WA 98198; telephone 516-
228-7317; email [email protected].

(l) Material Incorporated by Reference

    (1) The Director of the Federal Register approved the
incorporation by reference (IBR) of the service information listed
in this paragraph under 5 U.S.C. 552(a) and 1 CFR part 51.
    (2) You must use this service information as applicable to do
the actions required by this AD, unless this AD specifies otherwise.
    (i) Airbus Service Bulletin A350-53-P073, dated June 9, 2022.
    (ii) European Union Aviation Safety Agency (EASA) AD 2022-0183,
dated August 30, 2022.
    (3) For EASA AD 2022-0183, contact EASA, Konrad-Adenauer-Ufer 3,
50668 Cologne, Germany; telephone +49 221 8999 000; email
[email protected]; website easa.europa.eu. You may find this EASA
AD on the EASA website at ad.easa.europa.eu.
    (4) For Airbus service information identified in this AD,
contact Airbus SAS, Airworthiness Office--EAL, Rond-Point Emile
Dewoitine No: 2, 31700 Blagnac Cedex, France; telephone +33 5 61 93
36 96; fax +33 5 61 93 45 80; email airbus.com">[email protected]airbus.com; website airbus.com.
    (5) You may view this material at the FAA, Airworthiness
Products Section, Operational Safety Branch, 2200 South 216th St.,
Des Moines, WA. For information on the availability of this material
at the FAA, call<PHONE_NUMBER>.
    (6) You may view this material that is incorporated by reference
at the National Archives and Records Administration (NARA). For
information on the availability of this material at NARA, email
[email protected], or go to: www.archives.gov/federal-register/cfr/ibr-locations.html.

    Issued on December 5, 2022.
Christina Underwood,
Acting Director, Compliance & Airworthiness Division, Aircraft
Certification Service.
[FR Doc. 2022-27403 Filed 12-16-22; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 78, Number 173 (Friday, September 6, 2013)]
[Notices]
[Pages 54941-54942]
[FR Doc No: 2013-21632]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-70295; File No. SR-BX-2013-016)

Self-Regulatory Organizations; NASDAQ OMX BX Inc.; Notice of
Designation of Longer Period for Commission Action on Proceedings To
Determine Whether To Approve or Disapprove the Proposed Rule Change To
Adopt a Directed Order Process

August 30, 2013.
    On February 21, 2013, NASDAQ OMX BX, Inc. (``Exchange'' or ``BX'')
filed with the Securities and Exchange Commission (``Commission''),
pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(``Act''),\1\ and Rule 19b-4 thereunder,\2\ a proposed rule change to
establish a directed order process. The proposed rule change was
published for comment in the Federal Register on March 11, 2013.\3\ The
Commission received a comment letter from one commenter on the
proposal,\4\ a letter responding to the comment,\5\ and a follow up
comment letter from the same commenter.\6\ In addition, on April 17,
2013, the Exchange filed Amendment No. 1 to the proposed rule
change.\7\ On April 22, 2013, the Exchange extended to June 6, 2013,
the time period within which the Commission must approve the proposed
rule change, disapprove the proposed rule change, or institute
proceedings to determine whether to disapprove the proposed rule
change. On June 3, 2013, the Commission instituted proceedings to
determine whether to approve or disapprove the proposed rule change.\8\
On July 1, 2013, BX submitted a letter in further support of its
proposed rule change.\9\ On July 15, 2013, the Commission received a
comment in response to BX's letter,\10\ and on August 28, 2013, BX
submitted a letter responding to the comment letter.\11\
---------------------------------------------------------------------------

    \1\ 15 U.S.C. 78a.
    \2\ 17 CFR 240.19b-4.
    \3\ See Securities Exchange Act Release No. 69040 (March 5,
2013), 78 FR 15385 (March 11, 2013).
    \4\ See Letter, dated April 2, 2013, to Elizabeth M. Murphy,
Secretary, Commission, from Janet McGuiness, Executive Vice
President, Secretary and General Counsel, NYSE Euronext.
    \5\ See Letter, dated April 17, 2013, to Elizabeth M. Murphy,
Secretary, Commission, from Edith Hallahan, Principal Associate
General Counsel, BX.
    \6\ See Letter, dated May 10, 2013, to Elizabeth M. Murphy,
Secretary, Commission, from Janet McGuiness, Executive Vice
President, Secretary and General Counsel, NYSE Euronext.
    \7\ For a description of Amendment No. 1, see Securities
Exchange Act Release No. 69684, 78 FR 34683 (June 10, 2013) (``Order
Instituting Proceedings'').
    \8\ See Order Instituting Proceedings, supra note 7.
    \9\ See Letter, dated July 1, 2013 to Elizabeth M. Murphy,
Secretary, Commission, from Edith Hallahan, Principal Associate
General Counsel, BX.
    \10\ See Letter, dated July 15, 2013 to Elizabeth M. Murphy,
Secretary, Commission, from Janet McGuiness, Executive Vice
President, Secretary and General Counsel, NYSE Euronext.
    \11\ See Letter, dated August 28, 2013 to Elizabeth M. Murphy,
Secretary, Commission, from Edith Hallahan, Principal Associate
General Counsel, BX.
---------------------------------------------------------------------------

    Section 19(b)(2) of the Act \12\ provides that, after initiating
disapproval proceedings, the Commission shall issue an order approving
or disapproving the proposed rule change not later than 180 days after
the date of publication of the notice of the filing of the proposed
rule change. The Commission may extend the period for issuing an order
approving or disapproving the proposed rule change, however, by not
more than 60 days if the Commission determines that a longer period is
appropriate and publishes the reasons for such determination. The
proposed rule change was published for notice and comment in the
Federal Register on March 11, 2013. September 7, 2013 is 180 days from
that date and November 6, 2013 is an additional 60 days from that date.
---------------------------------------------------------------------------

    \12\ 15. U.S.C. 78s(b)(2).
---------------------------------------------------------------------------

    The Commission finds it is appropriate to designate a longer period
within which to issue an order approving or disapproving the proposed

rule change so that it has sufficient time to consider the proposed
rule change, the issues raised in the comment letters that have been
submitted in connection with the proposed rule change, and the
Exchange's response to such issues in its response letter.
    Accordingly, the Commission, pursuant to Section 19(b)(2) of the
Act,\13\ designates November 6, 2013, as the date by which the
Commission shall either approve or disapprove the Proposal.
---------------------------------------------------------------------------

    \13\ 15 U.S.C. 78s(b)(2).

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\14\
---------------------------------------------------------------------------

    \14\ 17 CFR 200.30-3(a)(57).
---------------------------------------------------------------------------

Elizabeth M. Murphy,
Secretary.
[FR Doc. 2013-21632 Filed 9-5-13; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 82, Number 45 (Thursday, March 9, 2017)]
[Notices]
[Pages 13185-13187]
[FR Doc No: 2017-04643]

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DEPARTMENT OF TRANSPORTATION

Federal Motor Carrier Safety Administration

[FMCSA Docket No. FMCSA-2016-0008]

Qualification of Drivers; Exemption Applications; Epilepsy and
Seizure Disorders

AGENCY: Federal Motor Carrier Safety Administration (FMCSA), DOT.

ACTION: Notice of final disposition.

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

SUMMARY: FMCSA announces its decision to exempt nine individuals from
the requirement in the Federal

Motor Carrier Safety Regulations (FMCSRs) that interstate commercial
motor vehicle (CMV) drivers have ``no established medical history or
clinical diagnosis of epilepsy or any other condition which is likely
to cause loss of consciousness or any loss of ability to control a
CMV.'' The exemptions enable these individuals who have had one or more
seizures and are taking anti-seizure medication to operate CMVs in
interstate commerce.

DATES: The exemptions were effective on December 21, 2016. The
exemptions will expire on December 21, 2018.

FOR FURTHER INFORMATION CONTACT: Ms. Christine A. Hydock, Chief,
Medical Programs Division,<PHONE_NUMBER><EMAIL_ADDRESS>FMCSA,
Department of Transportation, 1200 New Jersey Avenue SE., Room W64-224,
Washington, DC 20590-0001. Office hours are from 8:30 a.m. to 5 p.m.
e.t., Monday through Friday, except Federal holidays. If you have
questions regarding viewing or submitting material to the docket,
contact Docket Services, telephone<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Electronic Access

    You may see all the comments online through the Federal Document
Management System (FDMS) at: http://www.regulations.gov.
    Docket: For access to the docket to read background documents or
comments, go to http://www.regulations.gov and/or Room W12-140 on the
ground level of the West Building, 1200 New Jersey Avenue SE.,
Washington, DC, between 9 a.m. and 5 p.m. e.t., Monday through Friday,
except Federal holidays.
    Privacy Act: In accordance with 5 U.S.C. 553(c), DOT solicits
comments from the public to better inform its rulemaking process. DOT
posts these comments, without edit, including any personal information
the commenter provides, to http://www.regulations.gov, as described in
the system of records notice (DOT/ALL-14 FDMS), which can be reviewed
at http://www.dot.gov/privacy.

II. Background

    On November 17, 2016, FMCSA published a notice announcing receipt
of applications from nine individuals requesting an exemption from the
epilepsy prohibition in 49 CFR 391.41(b)(8) and requested comments from
the public (81 FR 81233). The public comment period ended on December
19, 2016, and one comment was received.
    FMCSA has evaluated the eligibility of these applicants and
determined that granting exemptions to these individuals would achieve
a level of safety equivalent to or greater than the level that would be
achieved by complying with the current regulation 49 CFR 391.41(b)(8).
    The physical qualification standard for drivers regarding epilepsy
found in 49 CFR 391.41(b)(8) states that a person is physically
qualified to drive a CMV if that person:

    Has no established medical history or clinical diagnosis of
epilepsy or any other condition which is likely to cause the loss of
consciousness or any loss of ability to control a CMV.

    In addition to the regulations, FMCSA has published advisory
criteria \1\ to assist medical examiners in determining whether drivers
with certain medical conditions are qualified to operate a CMV in
interstate commerce. [49 CFR part 391, APPENDIX A TO PART 391--MEDICAL
ADVISORY CRITERIA, section H. Epilepsy: Sec.  391.41(b)(8), paragraphs
3, 4, and 5.]
---------------------------------------------------------------------------

    \1\ See http://www.ecfr.gov/cgi-bin/text-idx?SID=e47b48a9ea42dd67d999246e23d97970&mc=true&node=pt49.5.391&rgn=div5#ap49.5.391_171.a and https://www.gpo.gov/fdsys/pkg/CFR-2015-title49-vol5/pdf/CFR-2015-title49-vol5-part391-appA.pdf.
---------------------------------------------------------------------------

III. Discussion of Comments

    FMCSA received one comment from Shenella Carlisle, in this
preceding, who cited information from a 2004 article from the American
Academy of Neurology regarding the relative low crash risk of
individuals who have seizures or epilepsy. She believes that an
individual's primary care provider, who is familiar with the
individual's history and treatment plan, is best suited to decide his
or her vehicle crash risk.

IV. Basis for Exemption Determination

    Under 49 U.S.C. 31136(e) and 31315(b), FMCSA may grant an exemption
from the epilepsy/seizure standard in 49 CFR 391.41(b)(8) if the
exemption is likely to achieve an equivalent or greater level of safety
than would be achieved without the exemption. The exemption allows the
applicants to operate CMVs in interstate commerce.
    In reaching the decision to grant these exemption requests, FMCSA
considered the 2007 recommendations of the Agency's Medical Expert
Panel (MEP). The January 15, 2013, Federal Register notice (78 FR 3069)
provides the current MEP recommendations which is the criteria the
Agency uses to grant seizure exemptions.
    The Agency's decision regarding these exemption applications is
based on an individualized assessment of each applicant's medical
information, including the root cause of the respective seizure(s) and
medical information about the applicant's seizure history, the length
of time that has elapsed since the individual's last seizure, the
stability of each individual's treatment regimen and the duration of
time on or off of anti-seizure medication. In addition, the Agency
reviewed the treating clinician's medical opinion related to the
ability of the driver to safely operate a CMV with a history of seizure
and each applicant's driving record found in the Commercial Driver's
License Information System (CDLIS) for commercial driver's license
(CDL) holders, and interstate and intrastate inspections recorded in
the Motor Carrier Management Information System (MCMIS). For non-CDL
holders, the Agency reviewed the driving records from the State
Driver's Licensing Agency (SDLA).
    These nine applicants have been seizure-free over a range of 10 to
32 years while taking anti-seizure medication and maintained a stable
medication treatment regimen for the last two years. In each case, the
applicant's treating physician verified his or her seizure history and
supports the ability to drive commercially.
    A summary of each applicant's seizure history was discussed in the
November 17, 2016, Federal Register notice (81 FR 81233) and will not
be repeated in this notice.
    The Agency acknowledges the potential consequences of a driver
experiencing a seizure while operating a CMV. However, the Agency
believes the drivers granted this exemption have demonstrated that they
are unlikely to have a seizure and their medical condition does not
pose a risk to public safety.
    Consequently, FMCSA finds that in each case exempting these
applicants from the epilepsy/seizure standard in 49 CFR 391.41(b)(8) is
likely to achieve a level of safety equal to that existing without the
exemption.

IV. Conditions and Requirements

    The terms and conditions of the exemption are provided to the
applicants in the exemption document and includes the following: (1)
Each driver must remain seizure-free and maintain a stable treatment
during the two-year exemption period; (2) each driver must submit
annual reports from their treating physicians attesting to the
stability of treatment and that the driver has remained seizure-free;
(3) each driver must undergo an annual medical examination by a
certified Medical

Examiner, as defined by 49 CFR 390.5; and (4) each driver must provide
a copy of the annual medical certification to the employer for
retention in the driver's qualification file, or keep a copy of his/her
driver's qualification file if he/she is self-employed. The driver must
also have a copy of the exemption when driving, for presentation to a
duly authorized Federal, State, or local enforcement official.

V. Preemption

    During the period the exemption is in effect, no State shall
enforce any law or regulation that conflicts with this exemption with
respect to a person operating under the exemption.

VI. Conclusion

    Based upon its evaluation of the nine exemption applications, FMCSA
exempts the following drivers from the epilepsy/seizure standard, 49
CFR 391.41(b)(8), subject to the requirements cited above:

Mark Beery (PA)
Douglas Cantwell (TN)
Mark McDaniel (IL)
Ronnie Moody (NC)
Tye Moore (IN)
Jack Porcellini (PA)
Jeffrey Rathman (CO)
Douglas Simms Jr. (NC)
Tara Van Horn (PA)
    In accordance with 49 U.S.C. 31315(b)(1), each exemption is valid
for two years unless revoked earlier by FMCSA. The exemption will be
revoked if the following occurs: (1) The individual fails to comply
with the terms and conditions of the exemption; (2) the exemption has
resulted in a lower level of safety than was maintained prior to being
granted; or (3) continuation of the exemption would not be consistent
with the goals and objectives of 49 U.S.C. 31136 and 31315.

    Issued on: March 3, 2017.
Larry W. Minor,
Associate Administrator for Policy.
[FR Doc. 2017-04643 Filed 3-8-17; 8:45 am]
 BILLING CODE 4910-EX-P


[Federal Register Volume 79, Number 82 (Tuesday, April 29, 2014)]
[Notices]
[Pages 23981-23982]
[FR Doc No: 2014-09692]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2010-N-0623]

Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Voluntary Cosmetic
Registration Program

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA or we) is announcing
that a proposed collection of information has been submitted to the
Office of Management and Budget (OMB) for review and clearance under
the Paperwork Reduction Act of 1995.

DATES: Fax written comments on the collection of information by May 29,
2014.

ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be faxed to the Office
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer,
FAX:<PHONE_NUMBER>, or emailed to<EMAIL_ADDRESS>All
comments should be identified with the OMB control number 0910-0027.
Also include the FDA docket number found in brackets in the heading of
this document.

FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations,
Food and Drug Administration, 1350 Piccard Dr., PI50-400B, Rockville,
MD 20850<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has
submitted the following proposed collection of information to OMB for
review and clearance.

Voluntary Cosmetic Registration Program--21 CFR Parts 710 and 720 (OMB
Control Number 0910-0027)--Extension

    The Federal Food, Drug, and Cosmetic Act (the FD&C Act) provides us
with the authority to regulate cosmetic products in the United States.
Cosmetic products that are adulterated under section 601 of the FD&C
Act (21 U.S.C. 361) or misbranded under section 602 of the FD&C Act (21
U.S.C. 362) may not be distributed in interstate commerce. We have
developed the VCRP to assist us in carrying out our responsibility to
regulate cosmetics.
    In 21 CFR part 710, we request that establishments that manufacture
or package cosmetic products register with us on Form FDA 2511 entitled
``Registration of Cosmetic Product Establishment.'' The term ``Form FDA
2511'' refers to both the paper and electronic versions of the form.
The electronic version of Form FDA 2511 is available on our VCRP Web
site at http://www.fda.gov/Cosmetics/RegistrationProgram/OnlineRegistration/ucm090947.htm. We strongly encourage electronic
registration of Form FDA 2511 because it is faster and more convenient.
A registering facility will receive confirmation of electronic
registration, including a registration number, by email, usually within
7 business days. The online system also allows for amendments to past
submissions.
    Because registration of cosmetic product establishments is not
mandatory, voluntary registration provides us with the best information
available about the locations, business trade names, and types of
activity (manufacturing or packaging) of cosmetic product
establishments. We place the registration information in a computer
database and use the information to generate mailing lists for
distributing regulatory information and for inviting firms to
participate in workshops on topics in which they may be interested. We
also use the information for estimating the size of the cosmetic
industry and for conducting onsite establishment inspections.
Registration is permanent, although we request that respondents submit
an amended Form FDA 2511 if any of the originally submitted information
changes.
    In part 720 (21 CFR part 720), we request that firms that
manufacture, pack, or distribute cosmetics file with us an ingredient
statement for each of their products. Ingredient statements for new
submissions (Sec. Sec.  720.1 through 720.4) are reported on Form FDA
2512,

``Cosmetic Product Ingredient Statement,'' and on Form FDA 2512a, a
continuation form. Amendments to product formulations (Sec.  720.6)
also are reported on Forms FDA 2512 and FDA 2512a. When a firm
discontinues the commercial distribution of a cosmetic, we request that
the firm file Form FDA 2514, ``Notice of Discontinuance of Commercial
Distribution of Cosmetic Product Formulation'' (Sec. Sec.  720.3 and
720.6). If any of the information submitted on or with these forms is
confidential, the firm may submit a request for confidentiality under
Sec.  720.8.
    FDA's online filing system is available on FDA's VCRP Web site at
http://www.fda.gov/Cosmetics/RegistrationProgram/OnlineRegistration/ucm100241.htm. The online filing system contains the electronic
versions of Forms FDA 2512, 2512a, and 2514, which are collectively
found within the electronic version of Form FDA 2512.
    We place cosmetic product filing information in a computer database
and use the information for evaluation of cosmetic products currently
on the market. Because filing of cosmetic product formulations is not
mandatory, voluntary filings provide us with the best information
available about cosmetic product ingredients and their frequency of
use, businesses engaged in the manufacture and distribution of
cosmetics, and approximate rates of product discontinuance and formula
modifications. The information assists our scientists in evaluating
reports of alleged injuries and adverse reactions from the use of
cosmetics. We also use the information in defining and planning
analytical and toxicological studies pertaining to cosmetics.
    Information from the database is releasable to the public under our
compliance with the Freedom of Information Act. We share
nonconfidential information from our files on cosmetics with consumers,
medical professionals, and industry.
    In the Federal Register of February 6, 2014 (79 FR 7196), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. No comments were received.
    FDA estimates the burden of this collection of information as
follows:

                                                     Table 1--Estimated Annual Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                Annual
          21 CFR Section or Part                      Form no.                No. of       frequency per   Total annual      Hours per      Total hours
                                                                            respondents      response        responses       response
--------------------------------------------------------------------------------------------------------------------------------------------------------
Part 710 (registrations)..................  FDA 2511 \2\................              81               1              81             0.2              16
720.1 through 720.4 (ingredient statements  FDA 2512 \3\................           4,877               1           4,877            0.33           1,609
 for new submissions).
720.6 (amendments)........................  FDA 2512....................           1,042               1           1,042            0.17             177
720.6 (notices of discontinuance).........  FDA 2512....................           1,826               1           1,826             0.1             183
720.8 (requests for confidentiality)......  ............................               1               1               1             2.0             2.0
    Total.................................  ............................  ..............  ..............  ..............  ..............           1,987
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
\2\ The term ``Form FDA 2511'' refers to both the paper Form FDA 2511 and electronic Form FDA 2511 in the electronic system known as the Voluntary
  Cosmetic Registration Program, which is available at http://www.fda.gov/Cosmetics/RegistrationProgram/OnlineRegistration/ucm090947.htm.
\3\ The term ``Form FDA 2512'' refers to the paper Forms FDA 2512, 2512a, and 2514 and electronic Form FDA 2512 in the electronic system known as the
  Voluntary Cosmetic Registration Program, which is available at http://www.fda.gov/Cosmetics/RegistrationProgram/OnlineRegistration/ucm100241.htm.

    We base our estimate of the total annual responses on paper and
electronic submissions received during calendar years 2011, 2012 and
2013. We base our estimate of the hours per response upon information
from cosmetic industry personnel and our experience entering data
submitted on paper Forms 2511, 2512, 2512a, and 2514 into the
electronic system.
    We estimate that, annually, 81 establishments that manufacture or
package cosmetic products will each submit 1 registration on Form FDA
2511, for a total of 81 annual responses. Each submission is estimated
to take 0.2 hour per response for a total of 16.2 hours, rounded to 16.
We estimate that, annually, firms that manufacture, pack, or distribute
cosmetics will file 4,877 ingredient statements for new submissions on
Forms FDA 2512 and FDA 2512a. Each submission is estimated to take 0.33
hour per response for a total of 1,609.41 hours, rounded to 1,609. We
estimate that, annually, firms that manufacture, pack, or distribute
cosmetics will file 1,042 amendments to product formulations on Forms
FDA 2512 and FDA 2512a. Each submission is estimated to take 0.17 hour
per response for a total of 177.14 hours, rounded to 177. We estimate
that, annually, firms that manufacture, pack, or distribute cosmetics
will file 1,826 notices of discontinuance on Form FDA 2514. Each
submission is estimated to take 0.1 hour per response for a total of
182.6 hours, rounded to 183. We estimate that, annually, one firm will
file one request for confidentiality. Each such request is estimated to
take 2 hours to prepare for a total of 2.0 hours. Thus, the total
estimated hour burden for this information collection is 1,987 hours.

    Dated: April 21, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-09692 Filed 4-28-14; 8:45 am]
BILLING CODE 4160-01-P