[Federal Register Volume 83, Number 233 (Tuesday, December 4, 2018)]
[Rules and Regulations]
[Pages 62475-62479]
[FR Doc No: 2018-26353]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2018-0091; FRL-9986-06]

Calcium Formate; Exemption From the Requirement of a Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes an exemption from the requirement
of a tolerance for residues of calcium formate (CAS Reg. No. 544-17-2)
when used as an inert ingredient (carrier) in pesticide formulations
applied to growing crops only. ADAMA Agan, Ltd. c/o Makhteshim Agan of
North America, Inc. submitted a petition to EPA under the Federal Food,
Drug, and Cosmetic Act (FFDCA), requesting establishment of an
exemption from the requirement of a tolerance. This regulation
eliminates the need to establish a maximum permissible level for
residues of calcium formate.

DATES: This regulation is effective December 4, 2018. Objections and
requests for hearings must be received on or before February 4, 2019,
and must be filed in accordance with the instructions provided in 40
CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).

ADDRESSES: The docket for this action, identified by docket
identification (ID) number EPA-HQ-OPP-2018-0091, is available at http://www.regulations.gov or at the Office of Pesticide Programs Regulatory
Public Docket (OPP Docket) in the Environmental Protection Agency
Docket Center (EPA/DC), West William Jefferson Clinton Bldg., Rm. 3334,
1301 Constitution Ave., NW, Washington, DC 20460-0001. The Public
Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through
Friday, excluding legal holidays. The telephone number for the Public
Reading Room is<PHONE_NUMBER>, and the telephone number for the OPP
Docket is<PHONE_NUMBER>. Please review the visitor instructions and
additional information about the docket available at http://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: Michael L. Goodis, Director,
Registration Division (7505P), Office of Pesticide Programs,
Environmental Protection Agency, 1200 Pennsylvania Ave., NW,
Washington, DC 20460-0001; main telephone number:<PHONE_NUMBER>; email
address: [email protected].

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this action apply to me?

    You may be potentially affected by this action if you are an
agricultural producer, food manufacturer, or pesticide manufacturer.
The following list of North American Industrial Classification System
(NAICS) codes is not intended to be exhaustive, but rather provides a
guide to help readers determine whether this document applies to them.
Potentially affected entities may include:

 Crop production (NAICS code 111).
 Animal production (NAICS code 112).
 Food manufacturing (NAICS code 311).
 Pesticide manufacturing (NAICS code 32532).

B. How can I get electronic access to other related information?

    You may access a frequently updated electronic version of 40 CFR
part 180 through the Government Printing Office's e-CFR site at http://www.ecfr.gov/cgi-bin/text-idx?&c=ecfr&tpl=/ecfrbrowse/Title40/40tab_02.tpl. To access the OCSPP test guidelines referenced in this
document electronically, please go to http://www.epa.gov/ocspp and
select ``Test Methods and Guidelines.''

C. How can I file an objection or hearing request?

    Under FFDCA section 408(g), 21 U.S.C. 346a, any person may file an
objection to any aspect of this regulation and may also request a
hearing on those objections. You must file your objection or request a
hearing on this regulation in accordance with the instructions provided
in 40 CFR part 178. To ensure proper receipt by EPA, you must identify
docket ID number EPA-HQ-OPP-2018-0091 in the subject line on the first
page of your submission. All objections and requests for a hearing must
be in writing, and must be received by the Hearing Clerk on or before
February 4, 2019. Addresses for mail and hand delivery of objections
and hearing requests are provided in 40 CFR 178.25(b).
    In addition to filing an objection or hearing request with the
Hearing Clerk as described in 40 CFR part 178, please submit a copy of
the filing (excluding any Confidential Business Information (CBI)) for
inclusion in the public docket. Information not marked confidential
pursuant to 40 CFR part 2 may be disclosed publicly by EPA without
prior notice. Submit the non-CBI copy of your objection or hearing
request, identified by docket ID number EPA-HQ-OPP-2018-0091, by one of
the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov.
Follow the online instructions for submitting comments. Do not submit
electronically any information you consider to be CBI or other
information whose disclosure is restricted by statute.
     Mail: OPP Docket, Environmental Protection Agency Docket
Center (EPA/DC), (28221T), 1200 Pennsylvania Ave. NW, Washington, DC
20460-0001.
     Hand Delivery: To make special arrangements for hand
delivery or delivery of boxed information, please follow the
instructions at http://www.epa.gov/dockets/contacts.html.
    Additional instructions on commenting or visiting the docket, along
with more information about dockets generally, is available at http://www.epa.gov/dockets.

II. Petition for Exemption

    In the Federal Register of April 11, 2018 (83 FR 15528) (FRL-9975-
57), EPA issued a document pursuant to FFDCA section 408, 21 U.S.C.
346a, announcing the filing of a pesticide petition (PP IN-11075) by
ADAMA Agan, Ltd. c/o Makhteshim Agan of North America, Inc., 3120
Highwoods Blvd., Suite 100, Raleigh, NC 27604. The petition requested
that 40 CFR 180.920 be amended by establishing an exemption from the
requirement of a tolerance for residues of calcium formate (CAS Reg.
No. 544-17-2) when used as an inert ingredient (carrier) in pesticide
formulations applied to growing crops only. That document referenced a
summary of the petition prepared by ADAMA Agan, LTD, the petitioner,
which is available in the docket, http://www.regulations.gov.
    This is based on the Agency's risk assessment which can be found at
http://www.regulations.gov in document: Calcium Formate; Human Health
Risk Assessment in docket ID number EPA-HQ-OPP-2018-0091. No comments
were received in response to the notice published by EPA.

III. Inert Ingredient Definition

    Inert ingredients are all ingredients that are not active
ingredients as defined in 40 CFR 153.125 and include, but are not
limited to, the following types of ingredients (except when they have a
pesticidal efficacy of their own): Solvents such as alcohols and
hydrocarbons; surfactants such as polyoxyethylene polymers and fatty
acids; carriers such as clay and

diatomaceous earth; thickeners such as carrageenan and modified
cellulose; wetting, spreading, and dispersing agents; propellants in
aerosol dispensers; microencapsulating agents; and emulsifiers. The
term ``inert'' is not intended to imply nontoxicity; the ingredient may
or may not be chemically active. Generally, EPA has exempted inert
ingredients from the requirement of a tolerance based on the low
toxicity of the individual inert ingredients.

IV. Aggregate Risk Assessment and Determination of Safety

    Section 408(c)(2)(A)(i) of FFDCA allows EPA to establish an
exemption from the requirement for a tolerance (the legal limit for a
pesticide chemical residue in or on a food) only if EPA determines that
the tolerance is ``safe.'' Section 408(b)(2)(A)(ii) of FFDCA defines
``safe'' to mean that ``there is a reasonable certainty that no harm
will result from aggregate exposure to the pesticide chemical residue,
including all anticipated dietary exposures and all other exposures for
which there is reliable information.'' This includes exposure through
drinking water and in residential settings, but does not include
occupational exposure. Section 408(b)(2)(C) of FFDCA requires EPA to
give special consideration to exposure of infants and children to the
pesticide chemical residue in establishing a tolerance and to ``ensure
that there is a reasonable certainty that no harm will result to
infants and children from aggregate exposure to the pesticide chemical
residue . . . .''
    EPA establishes exemptions from the requirement of a tolerance only
in those cases where it can be clearly demonstrated that the risks from
aggregate exposure to pesticide chemical residues under reasonably
foreseeable circumstances will pose no appreciable risks to human
health. In order to determine the risks from aggregate exposure to
pesticide inert ingredients, the Agency considers the toxicity of the
inert in conjunction with possible exposure to residues of the inert
ingredient through food, drinking water, and through other exposures
that occur as a result of pesticide use in residential settings. If EPA
is able to determine that a finite tolerance is not necessary to ensure
that there is a reasonable certainty that no harm will result from
aggregate exposure to the inert ingredient, an exemption from the
requirement of a tolerance may be established.
    Consistent with FFDCA section 408(c)(2)(A), and the factors
specified in FFDCA section 408(c)(2)(B), EPA has reviewed the available
scientific data and other relevant information in support of this
action. EPA has sufficient data to assess the hazards of and to make a
determination on aggregate exposure for calcium formate including
exposure resulting from the exemption established by this action. EPA's
assessment of exposures and risks associated with calcium formate
follows.

A. Toxicological Profile

    EPA has evaluated the available toxicity data and considered their
validity, completeness, and reliability as well as the relationship of
the results of the studies to human risk. EPA has also considered
available information concerning the variability of the sensitivities
of major identifiable subgroups of consumers, including infants and
children.
    The toxicity database on calcium formate is somewhat limited.
Consequently, studies on appropriate surrogates were used to supplement
the database on calcium formate. Formic acid, sodium formate, potassium
formate and ammonium formate were selected as appropriate surrogates
since they are either the acid form of calcium formate or other salts
of formic acid.
    Calcium formate is not expected to be acutely toxic based on acute
toxicity data. There are no subchronic or chronic studies on calcium
formate, although there are studies on potassium formate. These studies
show effects based on reduced body weight gain. A two-year study with
potassium formate indicates the compound is not carcinogenic to Wistar
rats.
    In mutagenicity studies with calcium formate, sodium formate and
methyl formate, results of the test were negative for all chemicals.
The weight-of-evidence suggests that calcium is not expected to be
mutagenic.
    There are no available developmental toxicity studies on calcium
formate; however, both a rat and rabbit developmental toxicity study
have been conducted on sodium formate. In the rat study, the maternal
and developmental no-observed-adverse-effect-level (NOAEL) was
considered the highest dose tested at 945 milligram/kilogram/day (mg/
kg/day). In the rabbit study, the maternal and developmental toxicity
NOAEL was also the highest dose tested at 1,000 mg/kg/day. A five-
generation rat reproductive toxicity study on calcium formate has been
conducted with a NOAEL of >200 mg/kg/day (only dose tested). In a
three-generation reproduction study in rats via drinking water, no
treatment related effects were observed in the parental animals and off
springs at doses up to 200 mg/kg/day.
    No studies were submitted for immunotoxicity. However, the toxicity
studies available did not show any signs of immunotoxicity up to limit
doses. Therefore, immunotoxicity is not of concern.
    There are no available studies for neurotoxicity. However, the
functional observation battery performed in the 90-day oral toxicity
study did not show any signs of neurotoxicity up to limit doses.
Therefore, neurotoxicity is not of concern.
    A metabolism study is available in the toxicity database. Calcium
formate breaks down into calcium and formate ions. Calcium ions are
ubiquitous in the natural environment and can be considered as having
little toxicity or hazard. Formate ions are readily converted to carbon
dioxide in the environment by biodegradation or photooxidation.
    Specific information on the studies received and the nature of the
adverse effects caused by calcium formate as well as the NOAEL and the
lowest-observed-adverse-effect-level (LOAEL) from the toxicity studies
can be found at http://www.regulations.gov in the document Calcium
Formate Risk Assessment at page 7 in docket ID number EPA-HQ-OPP-2018-
0091.

B. Toxicological Points of Departure/Levels of Concern

    Once a pesticide's toxicological profile is determined, EPA
identifies toxicological points of departure (POD) and levels of
concern to use in evaluating the risk posed by human exposure to the
pesticide. For hazards that have a threshold below which there is no
appreciable risk, the toxicological POD is used as the basis for
derivation of reference values for risk assessment. PODs are developed
based on a careful analysis of the doses in each toxicological study to
determine the dose at which no adverse effects are observed (the NOAEL)
and the lowest dose at which adverse effects of concern are identified
(the LOAEL). Uncertainty/safety factors are used in conjunction with
the POD to calculate a safe exposure level--generally referred to as a
population-adjusted dose (PAD) or a reference dose (RfD)--and a safe
margin of exposure (MOE). For non-threshold risks, the Agency assumes
that any amount of exposure will lead to some degree of risk. Thus, the
Agency estimates risk in terms of the probability of an occurrence of
the adverse effect expected in a lifetime. For more information on the
general principles EPA uses in risk characterization and a

complete description of the risk assessment process, see http://www.epa.gov/pesticides/factsheets/riskassess.htm.
    No toxicological endpoints of concern were identified for calcium
formate based on available toxicity studies on surrogate chemicals.
Formic acid, sodium formate, potassium formate and ammonium formate
were selected as appropriate surrogates since they are either the acid
form of calcium formate or other salts of formic acid. Most of the
available studies on these substances were not conducted up to the
limit dose. The highest dose of 200 mg/kg/day in a lifelong study in
rats via drinking water did not produce any systemic toxicity (IUCLID,
Calcium formate, 2001). Therefore, a conservative risk assessment was
conducted using a NOAEL of 200 mg/kg/day for chronic dietary and short-
and intermediate-term dermal exposure risk estimates. An uncertainty/
safety factor of 100X (10X for interspecies variability and 10X for
interspecies extrapolation) was used. The Food Quality Protection Act
(FQPA) factor of 10X was reduced to 1X, therefore, the chronic
Reference Dose (cRfD) of 2 mg/kg/day is equal to the chronic Population
Adjusted Dose (cPAD). A 100% dermal absorption factor is assumed for
converting oral to dermal equivalent doses in the absence of dermal
toxicity or dermal absorption studies.
    For short and intermediate term inhalation exposure, the route
specific study was used. The NOAEL of 0.62 mg/l (32 parts per million
(ppm)) was observed in a 90-day inhalation toxicity study in rats
(IUCLID, Formic acid, 2000). The uncertainty factor is 100X (10X for
interspecies variability and IOX for interspecies extrapolation). The
FQPA factor of 10 X was reduced to 1X.

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary
exposure to calcium formate, EPA considered exposure under the proposed
exemption from the requirement of a tolerance. EPA assessed dietary
exposures from calcium formate in food as follows:
    Because no endpoint was identified for acute exposure, an acute
exposure assessment was not conducted.
    In conducting the chronic dietary exposure assessment using the
Dietary Exposure Evaluation Model DEEM-FCID\TM\, EPA used food
consumption information from the U.S. Department of Agriculture's
National Health and Nutrition Examination Survey, what we eat in
America, (NHANES/WWEIA). This dietary survey was conducted from 1994-
98. As to residue levels in food, no residue data were submitted. In
the absence of specific residue data, EPA has developed an approach
which uses surrogate information to derive upper bound exposure
estimates for the subject inert ingredient. Upper bound exposure
estimates are based on the highest tolerance for a given commodity from
a list of high-use insecticides, herbicides, and fungicides. A complete
description of the general approach taken to assess inert ingredient
risks in the absence of residue data is contained in the memorandum
entitled ``Alkyl Amines Polyalkoxylates (Cluster 4): Acute and Chronic
Aggregate (Food and Drinking Water) Dietary Exposure and Risk
Assessments for the Inerts.'' (D361707, S. Piper, 2/25/09) and can be
found at http://www.regulations.gov in docket ID number EPA-HQ-OPP-
2008-0738.
    In the dietary exposure assessment, the Agency assumed that the
residue level of the inert ingredient would be no higher than the
highest tolerance for a given commodity. Implicit in this assumption is
that there would be similar rates of degradation (if any) between the
active and inert ingredient and that the concentration of inert
ingredient in the scenarios leading to these highest of tolerances
would be no higher than the concentration of the active ingredient.
    The Agency believes the assumptions used to estimate dietary
exposures lead to an extremely conservative assessment of dietary risk
due to a series of compounded conservatisms. First, assuming that the
level of residue for an inert ingredient is equal to the level of
residue for the active ingredient will overstate exposure. The
concentration of active ingredients in agricultural products is
generally at least 50 percent of the product and often can be much
higher. Further, pesticide products rarely have a single inert
ingredient; rather there is generally a combination of different inert
ingredients used which additionally reduces the concentration of any
single inert ingredient in the pesticide product in relation to that of
the active ingredient.
    Second, the conservatism of this methodology is compounded by EPA's
decision to assume that, for each commodity, the active ingredient
which will serve as a guide to the potential level of inert ingredient
residues is the active ingredient with the highest tolerance level.
This assumption overstates residue values because it would be highly
unlikely, that a single inert ingredient or class of ingredients would
be present at the level of the active ingredient in the highest
tolerance for every commodity.
    Finally, a third compounding conservatism is EPA's assumption that
all foods contain the inert ingredient at the highest tolerance level.
In other words, EPA assumed 100 percent of all foods are treated with
the inert ingredient at the rate and manner necessary to produce the
highest residue legally possible for an active ingredient.
    In summary, EPA chose a very conservative method for estimating
what level of inert residue could be on food, and then used this
methodology to choose the highest possible residue that could be found
on food and assumed that all food contained this residue. No
consideration was given to potential degradation between harvest and
consumption even though monitoring data shows that tolerance level
residues are typically one to two orders of magnitude higher than
actual residues in food when distributed in commerce.
    Accordingly, although sufficient information to quantify actual
residue levels in food is not available, the compounding of these
conservative assumptions will lead to a significant exaggeration of
actual exposures. EPA does not believe that this approach
underestimates exposure in the absence of residue data.
    2. Dietary exposure from drinking water. For the purpose of the
screening level dietary risk assessment to support this request for an
exemption from the requirement of a tolerance for calcium formate, a
conservative drinking water concentration value of 100 parts per
billion (ppb) based on screening level modeling was used to assess the
contribution to drinking water for the chronic dietary risk assessments
for parent compound. These values were directly entered into the
dietary exposure model.
    3. From non-dietary exposure. The term ``residential exposure'' is
used in this document to refer to non-occupational, non-dietary
exposure (e.g., textiles (clothing and diapers), carpets, swimming
pools, and hard surface disinfection on walls, floors, tables).
    There are no known or anticipated residential uses for calcium
formate and therefore, residential exposure is not expected.
    4. Cumulative effects from substances with a common mechanism of
toxicity. Section 408(b)(2)(D)(v) of FFDCA requires that, when
considering whether to establish, modify, or revoke a tolerance, the
Agency consider ``available information'' concerning the cumulative
effects of a particular pesticide's residues and ``other

substances that have a common mechanism of toxicity.''
    EPA has not found calcium formate to share a common mechanism of
toxicity with any other substances, and calcium formate does not appear
to produce a toxic metabolite produced by other substances. For the
purposes of this tolerance action, therefore, EPA has assumed that
calcium formate does not have a common mechanism of toxicity with other
substances. For information regarding EPA's efforts to determine which
chemicals have a common mechanism of toxicity and to evaluate the
cumulative effects of such chemicals, see EPA's website at http://www.epa.gov/pesticides/cumulative.

D. Safety Factor for Infants and Children

    Section 408(b)(2)(c) of FFDCA provides that EPA shall apply an
additional tenfold (10X) margin of safety for infants and children in
the case of threshold effects to account for pre-natal and post-natal
toxicity and the completeness of the database on toxicity and exposure
unless EPA determines, based on reliable data, that a different margin
of safety will be safe for infants and children. This additional margin
of safety is commonly referred to as the FQPA Safety Factor (SF). In
applying this provision, EPA either retains the default value of 10X,
or uses a different additional safety factor when reliable data is
available to EPA to support the choice of a different factor.
    EPA has determined that reliable data show the safety of infants
and children would be adequately protected if the FQPA SF were reduced
to 1X. That decision is based on the following findings:
    1. Toxicological studies were identified for calcium formate in the
publicly available databases. However, calcium formate breaks down into
calcium and formate ions. Calcium ions are ubiquitous in the natural
environment and can be considered as having little toxicity or hazard
risk. The toxicological database for calcium formate is limited. There
is available data on formic acid and related formate compounds (such as
ammonium, sodium and methyl formate), which can serve as suitable
surrogates for calcium formate. Studies conducted with methanol are
also applicable to formate compounds, since methanol is metabolized
into formic acid. Therefore, the database is considered adequate for
FQPA assessment.
    2. There is no evidence of increased susceptibility of infants and
children in the available reproduction and developmental toxicity
studies with calcium formate and/or sodium formate. No developmental or
maternal systemic toxicity was observed in rats at doses up to 200 mg/
kg/day when calcium format was administered via drinking water. No
developmental or maternal toxicity was observed in mice at doses up to
750 mg/kg gavage dose of sodium formate on gestation day 8. No evidence
of increased susceptibility was observed following pre- and post-natal
exposure to calcium formate. In a multigeneration reproduction study
(three to five generations), no parental, reproductive or offspring
toxicity was observed at doses up to 200 mg/kg/day.
    3. No neurotoxicity studies are available in the database. However,
there is no evidence of clinical signs of neurotoxicity in the
database, nor evidence of susceptibility in the young in the database.
Therefore, EPA concluded that the developmental neurotoxicity study is
not required. There is no evidence of immunotoxicity in the available
database.
    4. The dietary food exposure assessment utilizes highly
conservative default assumptions that would not under estimate the
dietary risk to all populations. For the purpose of the screening level
dietary risk assessment to support this request for an exemption from
the requirement of a tolerance for ammonium formate, a value of 100 ppb
for drinking water based on screening level modeling was used for the
chronic dietary risk assessment. The value of 100 ppb is considered to
be a high end, conservative assumption that is not likely to
underestimate drinking water risks.
    Taking into consideration the available information, EPA concludes
the additional 10X FQPA safety factor can be reduced to 1X. These
assessments will not underestimate the exposure and risks posed by
calcium formate.

E. Aggregate Risks and Determination of Safety

    Taking into consideration all available information on calcium. EPA
has determined that there is a reasonable certainty that no harm to any
population subgroup will result from aggregate exposure to calcium
formate under reasonable foreseeable circumstances. Therefore, the
establishment of an exemption from tolerance under 40 CFR 180.920 for
residues of calcium formate when used as an inert ingredient in
pesticide formulations applied is safe under FFDCA section 408.
    1. Acute risk. An acute aggregate risk assessment takes into
account acute exposure estimates from dietary consumption of food and
drinking water. No adverse effect resulting from a single oral exposure
was identified and no acute dietary endpoint was selected. Therefore,
calcium formate is not expected to pose an acute risk.
    2. Chronic risk. Using the exposure assumptions described in this
unit for chronic exposure analysis, EPA has concluded that risk
estimates for chronic exposure to calcium formate from food and water
are not of concern (<100% cPAD with a risk estimate at 31.2% of the
cPAD for children 1-2 years old, the population group receiving the
greatest exposure. There are no residential uses for calcuim formate.
    3. Short-and intermediate term risk. Short- and intermediate-term
toxicological endpoints were established; however, calcium formate is
not registered for any use patterns that would result in short- or
intermediate-term residential exposure. Short- and intermediate-term
risk is assessed based on short- and intermediate-term residential
exposure plus chronic dietary exposure. Because there is no short- or
intermediate-term residential exposure and chronic dietary exposure has
already been assessed under the appropriately protective cPAD (which is
at least as protective as the POD used to assess short-term risk), no
further assessment of short- or intermediate-term risk is necessary,
and EPA relies on the chronic dietary risk assessment for evaluating
short- and intermediate-term risk for calcium formate.
    4. Aggregate cancer risk U.S. population. Based on the lack of
evidence of carcinogenicity in two adequate rodent carcinogenicity
studies, calcium formate is not expected to pose a cancer risk to
humans.
    5. Determination of safety. Based on these risk assessments, EPA
concludes that there is a reasonable certainty that no harm will result
to the general population, or to infants and children from aggregate
exposure to calcium formate residues.

V. Analytical Enforcement Methodology

    An analytical method is not required for enforcement purposes since
the Agency is establishing an exemption from the requirement of a
tolerance without any numerical limitation.

VI. Conclusions

    Therefore, an exemption from the requirement of a tolerance is
established under 40 CFR 180.920 for calcium formate (CAS Reg. No. 544-
17-2) when used as an inert ingredient (carrier) in pesticide
formulations applied to growing crops only.

VII. Statutory and Executive Order Reviews

    This action establishes an exemption from the requirement of a
tolerance under FFDCA section 408(d) in response to a petition
submitted to the Agency. The Office of Management and Budget (OMB) has
exempted these types of actions from review under Executive Order
12866, entitled ``Regulatory Planning and Review'' (58 FR 51735,
October 4, 1993). Because this action has been exempted from review
under Executive Order 12866, this action is not subject to Executive
Order 13211, entitled ``Actions Concerning Regulations That
Significantly Affect Energy Supply, Distribution, or Use'' (66 FR
28355, May 22, 2001) or Executive Order 13045, entitled ``Protection of
Children from Environmental Health Risks and Safety Risks'' (62 FR
19885, April 23, 1997), or Executive Order 13771, entitled ``Reducing
Regulations and Controlling Regulatory Costs'' (82 FR 9339, February 3,
2017). This action does not contain any information collections subject
to OMB approval under the Paperwork Reduction Act (PRA) (44 U.S.C. 3501
et seq.), nor does it require any special considerations under
Executive Order 12898, entitled ``Federal Actions to Address
Environmental Justice in Minority Populations and Low-Income
Populations'' (59 FR 7629, February 16, 1994).
    Since tolerances and exemptions that are established on the basis
of a petition under FFDCA section 408(d), such as the exemption in this
final rule, do not require the issuance of a proposed rule, the
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et
seq.), do not apply.
    This action directly regulates growers, food processors, food
handlers, and food retailers, not States or tribes, nor does this
action alter the relationships or distribution of power and
responsibilities established by Congress in the preemption provisions
of FFDCA section 408(n)(4). As such, the Agency has determined that
this action will not have a substantial direct effect on States or
tribal governments, on the relationship between the national government
and the States or tribal governments, or on the distribution of power
and responsibilities among the various levels of government or between
the Federal Government and Indian tribes. Thus, the Agency has
determined that Executive Order 13132, entitled ``Federalism'' (64 FR
43255, August 10, 1999) and Executive Order 13175, entitled
``Consultation and Coordination with Indian Tribal Governments'' (65 FR
67249, November 9, 2000) do not apply to this action. In addition, this
action does not impose any enforceable duty or contain any unfunded
mandate as described under Title II of the Unfunded Mandates Reform Act
(UMRA) (2 U.S.C. 1501 et seq.).
    This action does not involve any technical standards that would
require Agency consideration of voluntary consensus standards pursuant
to section 12(d) of the National Technology Transfer and Advancement
Act (NTTAA) (15 U.S.C. 272 note).

VIII. Congressional Review Act

    Pursuant to the Congressional Review Act (5 U.S.C. 801 et seq.),
EPA will submit a report containing this rule and other required
information to the U.S. Senate, the U.S. House of Representatives, and
the Comptroller General of the United States prior to publication of
the rule in the Federal Register. This action is not a ``major rule''
as defined by 5 U.S.C. 804(2).

List of Subjects in 40 CFR Part 180

    Environmental protection, Administrative practice and procedure,
Agricultural commodities, Pesticides and pests, Reporting and
recordkeeping requirements.

    Dated: November 14, 2018.
Donna Davis,
Acting Director, Registration Division, Office of Pesticide Programs.

    Therefore, 40 CFR chapter I is amended as follows:

PART 180--[AMENDED]

0
1. The authority citation for part 180 continues to read as follows:

    Authority:  21 U.S.C. 321(q), 346a and 371.

0
2. In Sec.  180.920, add alphabetically the inert ingredient to the
table to read as follows:

Sec.  180.920  Inert ingredients used pre-harvest; exemptions from the
requirement of a tolerance.

* * * * *

------------------------------------------------------------------------
         Inert ingredients              Limits              Uses
------------------------------------------------------------------------

                              * * * * * * *
Calcium formate (CAS Reg. No. 544-  ..............  Carrier
 17-2).

                              * * * * * * *
------------------------------------------------------------------------

[FR Doc. 2018-26353 Filed 12-3-18; 8:45 am]
 BILLING CODE 6560-50-P


[Federal Register: November 15, 2006 (Volume 71, Number 220)]
[Notices]
[Page 66571-66574]
[DOCID:fr15no06-110]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-54706; File No. SR-NASDAQ-2006-036]

Self-Regulatory Organizations; The NASDAQ Stock Market LLC;
Notice of Filing and Immediate Effectiveness of Proposed Rule Change To
Exempt Certain Cross Transactions From NASDAQ Rule 3350(a)

November 3, 2006.
    Pursuant to Section 19(b)(1) under the Securities Exchange Act of
1934 (``Act''),\1\ and Rule 19b-4 thereunder,\2\ notice is hereby given
that on September 25, 2006, The NASDAQ Stock Market LLC (``Nasdaq''),
filed with the Securities and Exchange Commission (``Commission'' or
``SEC'') the proposed rule change as described in Items I and II below,
which Items have been prepared by Nasdaq. On October 31, 2006, Nasdaq
filed Amendment No. 1 to the proposed rule change.\3\ Nasdaq has
designated the proposed rule change, as amended, as constituting a non-
controversial rule change under Rule 19b-4(f)(6) under the Act,\4\
which renders the proposal, as amended, effective upon filing with the
Commission. The Commission is publishing this notice to solicit
comments on the proposed rule change, as amended, from interested
persons.
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    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
    \3\ Amendment No. 1 was a partial amendment in which Nasdaq made
certain technical changes following discussions with Commission
staff.
    \4\ 17 CFR 240.19b-4(f)(6).
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I. Self-Regulatory Organization's Statement of the Terms of Substance
of the Proposed Rule Change

    Nasdaq proposes to exempt all transactions executed in the Nasdaq
Crossing Network pursuant to NASDAQ Rule 4770 from the price test set
forth in NASDAQ Rule 3350(a). Nasdaq plans to implement the proposed
rule change, as amended, on November 6, 2006.
    The text of the proposed rule change is below. Proposed new
language is underlined; proposed deletions are in brackets.\5\
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    \5\ Changes are marked to the rule text that appears in the
electronic NASDAQ Manual found at http://www.nasdaqtrader.com.

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* * * * *
3350 Short Sale Rule
    (a)-(b) No Change.
    (c)(1)-(10) No Change.
    (11) Short sales of securities in the Nasdaq Crossing Network
pursuant to NASDAQ Rule 4770 provided that:
    (a) Such short sales involve securities that comprise the S&P 500
Index;
    (b) Such short sales involve securities that qualify as ``actively-
traded securities'' under Regulation M; or
    (c) Such short sales are part of a basket transaction of 20 or more
securities in which the subject security does not comprise more than
five percent of the value of the basket traded.
    (d)-(l) No Change.

II. Self-Regulatory Organization's Statement of the Purpose of, and
Statutory Basis for, the Proposed Rule Change

    In its filing with the Commission, Nasdaq included statements
concerning the purpose of and basis for the proposed rule change and
discussed any comments it received on the proposed rule change. The
text of these statements may be examined at the places specified in
Item IV below. Nasdaq has prepared summaries, set forth in Sections A,
B, and C below, of the most significant aspects of such statements.

A. Self-Regulatory Organization's Statement of the Purpose of, and
Statutory Basis for, the Proposed Rule Change

1. Purpose
    Nasdaq is proposing to amend Rule 3350(c) to create an exemption
from the short sale rule for transactions executed in the Nasdaq
Crossing Network pursuant to NASDAQ Rule 4770. Nasdaq states that Rule
3350, voluntarily adopted by the NASD in 1994, is modeled closely on
SEC Rule 10a-1.\6\ Nasdaq notes that in its January 13, 2006 order
approving Nasdaq's registration as a national securities exchange, the
Commission granted Nasdaq an exemption from Rule 10a-1 to permit the
continued application of Rule 3350 to the trading of Nasdaq-listed
securities on Nasdaq.\7\ Nasdaq notes, however, that Rule 10a-1
continues to apply to Nasdaq's trading of securities listed on other
national securities exchanges.
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    \6\ Securities Exchange Act Release No. 34277 (June 29, 1994),
59 FR 34885 (July 7, 1994).
    \7\ Securities Exchange Act Release No. 53128 (January 13,
2006), 71 FR 3550 (January 23, 2006). Nasdaq Rule 3350 will continue
to apply to Nasdaq Global Market securities and not to Nasdaq
Capital Market securities.
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    Background. Nasdaq states that the Nasdaq Crossing Network will
consist of a series of trading day and after hours Reference Price
Crosses. Nasdaq states that Reference Price Crosses involve the
execution of trades at an externally derived price and in accordance
with a predetermined algorithm. Nasdaq asserts that the purpose of the
Nasdaq Crossing Network is to provide market participants and investors
with an accurate single trading price at specific times during and
after the trading day, resulting in an enhanced ability to execute
block trades quickly and anonymously, while minimizing market impact
and associated price movements. Nasdaq states that it expects to launch
the Nasdaq Crossing Network on November 6, 2006.
    Nasdaq explains that during the regular trading hours session (i.e.
9:30 a.m. to 4 p.m.), a series of Nasdaq Reference Price Crosses would
allow market participants to place orders that will be executed at the
midpoint of the national best bid and offer (``NBBO'') during a
designated trading window. An additional cross would be scheduled to
take place after the close of the trading day and eligible orders would
be executed at either the Nasdaq official closing price (``NOCP'') for
Nasdaq-listed securities or the official closing price of the primary
market (``Primary Market Close'') for non-Nasdaq securities. Nasdaq
states that eligible orders can be either market or limit orders and
must be designated for one or more Nasdaq Reference Price Crosses with
time-in-force indicators.\8\ Nasdaq notes that eligible orders will not
be displayed.
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    \8\ Orders may be submitted as existing market or limit order
types and would be designated by the firm upon entry with a time-in-
force indicator as follows: (i) participate in the next scheduled
regular hours cross with unexecuted shares being immediately
canceled back to the user after that cross (NXT), (ii) participate
in all of the regular hours crosses (i.e., 10:45 a.m., 12:45 p.m. or
2:45 p.m. ET) with unexecuted shares being immediately canceled back
to the user following the last regular hours cross (REG) or (iii)
participate in all crosses for the current day (i.e., 10:45 a.m.,
12:45 p.m., 2:45 p.m. and 4:30 p.m. ET) with unexecuted shares
immediately canceled back to the user following the after hours
cross (AHX).
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    Nasdaq states that it will execute the cross through an automated
and random matching mechanism at a randomly designated time during a
predetermined one minute trading window. Nasdaq notes that initially,
the Nasdaq Reference Price Crosses will commence during the trading day
at 10:45 a.m., 12:45 p.m. and 2:45 p.m. ET. In addition, an after hours
cross would take place at 4:30 p.m. ET.\9\
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    \9\ In the event that Nasdaq wishes to institute further
Reference Price Crosses or alter the timing of the crosses, it will
submit a rule change to the Commission.
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    Nasdaq states that orders would be required to be entered in round
lots with a minimum of one round lot and may designate a minimum
acceptable quantity for execution. In addition, Nasdaq notes that
orders may not be canceled or replaced during the time of the cross,
but may at any other time, including periods when trading in the
applicable security is halted. Nasdaq states that Reference Price Cross
orders would be required to be available for automatic execution. All
market participants would be able to enter automatically executable
orders into the Nasdaq Market Center to participate in the Reference
Price Cross. Orders that are not automatically executable would not be
accommodated by the Reference Price Cross. Further, Nasdaq states that
Reference Price Crosses would have no order delivery capability and no
special orders would be accommodated.
    Nasdaq states that upon initiation of a cross, available shares
would be treated as if they were the same price and would be allocated
on a pro-rata basis to eligible orders. Such shares would be allocated
based on the original size of the order, not on the size of the
remaining unexecuted portion of the order. If additional shares remain
after the initial pro-rata allocation, those shares would continue to
be allocated pro-rata to eligible orders until a number of round lots
remain that is less than the number of eligible orders. Any remaining
shares would be allocated to the oldest eligible order.
    Nasdaq states that the executions would be reported to the market
participants via Nasdaq Market Center execution reports as a single
trade reflecting the aggregate shares executed. In addition, Nasdaq
notes that in order to reduce information leakage that could lead to
adverse price movements, executions would be reported as anonymous
trades, without identifying a contra party. Nasdaq also states that
each execution would be reported to the Nasdaq Market Center trade
reporting service for trade reporting, clearance and settlement.
    Rationale for Proposed Exemption. Nasdaq believes that exempting
the Reference Price Cross transactions from Rule 3350 is consistent
with the goals of short sale regulation. Nasdaq states that
Congressional and Commission objectives included allowing relatively
unrestricted short selling in an advancing market, preventing short
selling at successively lower prices; and preventing short sellers from
accelerating a declining market by exhausting all remaining bids at one
price level. Nasdaq asserts that given the algorithmic nature of the
Nasdaq crosses, the proposed exemption poses little risk to investors.
    Nasdaq states that in proposing Regulation SHO, the Commission
noted that, due to the passive nature of pricing and the lack of price
discovery, passive pricing systems ``generally do not appear to involve
the types of abuses that Exchange Act Rule 10a-1 was designed to
prevent.'' \10\ Nasdaq states that the Commission also noted that one
of the reasons for its proposed bid test was to ``better accommodate
the recent growth of matching systems that execute trades at an
independently derived price above the consolidated best bid.'' \11\ In
addition, Nasdaq states that in connection with the representations
made by other parties requesting relief for similar matching systems,
the Commission took the view that these trades would not appear to
involve the types of abuses that Rule 10a-1 was designed to
address.\12\
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    \10\ See Securities Exchange Act Release No. 48709 (October 28,
2003), 68 Fed. Reg. 62972, 62982 (November 6, 2003).
    \11\ Id. Although the Commission decided to defer consideration
on adopting a uniform bid test until the conclusion of the Pilot
Program established under Rule 202T of Regulation SHO, this decision
does not appear to be related to the Commission's views on passive
pricing systems.
    \12\ See e.g., Letter from James A. Brigagliano, Assistant
Director, SEC, to Anitra T. Cassas, Wilmer, Cutler & Pickering, LLP
(April 22, 2005) (granting ITG an extension of modified exemptive
relief from Rule 10a-1 for certain transactions executed through
ITG's Portfolio System for Institutional Trading; see also Letter
from James A. Brigagliano, Acting Associate Director, SEC, to Alan
G. Reed, Instinet Group, LLC (June 15, 2006) (granting Instinet an
extension of exemptive relief from Rule 10a-1 for transactions
executed through Instinet's Intraday Crossing System).

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    Nasdaq believes that, consistent with the Commission's articulated
belief regarding passive pricing systems and its view with respect to
similar matching systems, trades executed in the Nasdaq Crossing
Network are not the types of abuses that Rule 3350 was designed to
address. Nasdaq states that the purpose of the Reference Price Cross is
to provide an accurate single trading price at specific times of the
day, resulting in an enhanced ability to execute block trades quickly
and anonymously, thereby minimizing market impact and associated price
movements.
    Nasdaq notes that the Reference Price Crosses are designed to occur
at an externally derived price and in accordance with a predetermined
algorithm. There would be no price discovery, as orders would not be
displayed and prices of orders are not specified, providing minimal
information to persons interested in engaging in abusive short sale
practices. Nasdaq also states that because a customer cannot predict in
advance the final execution price of the cross, which during the
trading day will be the mid-point of the NBBO and, for post-close cross
executions, the NOCP for Nasdaq-listed securities or the Primary Market
Close for non-Nasdaq-listed securities, the cross transactions will not
exert downward pressure on a subject stock's price. In addition, Nasdaq
notes that all short sale orders will be marked in accordance with Rule
200(g) of Regulation SHO.
    Furthermore, Nasdaq states that each Reference Price Cross will
occur through an automated and random matching mechanism at a randomly
selected time during a predetermined one minute trading window so no
participant will know precisely when a match will occur, and no
participant will be assured of receiving a match. During each one-
minute trading window of cross, there will not be solicitation of
orders from customers, nor will there be any communication to customers
that the match has not yet occurred.
    Nasdaq notes that the exemption for the Crossing Network would
apply to short sale transactions involving securities that comprise the
S&P 500 Index or that qualify as ``actively-traded securities'' under
Regulation M.\13\ If the Reported Security is not an S&P 500 Index
security or an ``actively-traded security,'' the exemption would apply
only if the transaction is part of a basket transaction of 20 or more
securities in which the subject security does not comprise more than
five percent of the value of the basket traded.
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    \13\ 17 CFR 242.101(c)(1). Under Rule 101(c)(1) of Regulation M,
actively-traded securities have an average daily trading volume
(ADTV) value of at least $1 million and are issued by an issuer with
a public float value of at least $150 million. For purposes of this
letter, the ADTV would be calculated in reference to the date on
which the proposed Nasdaq Reference Price Cross is to take place.
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    Nasdaq states that it is working with NASD to develop procedures to
monitor for signs of manipulation and suspicious activity, which
systems will be in place by the launch date of the Crossing
Network.\14\ Nasdaq states that in connection with these procedures,
Nasdaq will advise persons relying on this exemption to participate in
the Crossing Network that they may not be represented in the primary
market offer or otherwise influence the NBBO at the time of the
transaction. Furthermore, Nasdaq states that it will advise such
persons that transactions effected on the Crossing Network shall not be
made for the purpose of creating actual, or apparent, active trading in
or depressing, or otherwise manipulating, the price of any security.
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    \14\ The surveillance systems specifically designed for the
Reference Price Crosses will be in place for the launch of the
Reference Price Crosses, currently scheduled for November 6, 2006.
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    Nasdaq states that the proposed exemption will also remove the
disparity in short sale regulation that Nasdaq believes currently
exists between markets. Nasdaq asserts that as opposed to Nasdaq, which
has voluntarily adopted a short sale rule for Nasdaq securities,
several exchanges that trade Nasdaq securities do so with no short sale
regulation, encouraging market participants to route short sale orders
to their markets to avoid any regulatory restriction. As a result,
Nasdaq believes that the level of regulatory protection an investor
receives depends almost entirely on the market to which the investor's
order is routed. Nasdaq states that this disparity harms customers on
all markets by forcing traders to choose between bypassing limit orders
posted on Nasdaq, delaying executing those orders, or declining to
execute. Nasdaq states that the proposed exemption is designed to help
to alleviate these issues.
2. Statutory Basis
    Nasdaq believes that the proposed rule change, as amended, is
consistent with the provisions of Section 6 of the Act,\15\ in general,
and with Section 6(b)(5) of the Act,\16\ in particular, in that it is
designed to prevent fraudulent and manipulative acts and practices, to
promote just and equitable principles of trade, remove impediments to a
free and open market and a national market system, and, in general, to
protect investors and the public interest.
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    \15\ 15 U.S.C. 78f.
    \16\ 15 U.S.C. 78f(b)(5).
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B. Self-Regulatory Organization's Statement on Burden on Competition

    Nasdaq does not believe that the proposed rule change, as amended,
will result in any burden on competition that is not necessary or
appropriate in furtherance of the purposes of the Act.

C. Self-Regulatory Organization's Statement on Comments on the Proposed
Rule Change Received From Members, Participants, or Others

    Written comments were neither solicited nor received.

III. Date of Effectiveness of the Proposed Rule Change and Timing for
Commission Action

    (a) This proposed rule change, as amended, is filed pursuant to
paragraph (A) of section 19(b)(3) of the Act.
    (b) Because the foregoing rule change does not: (i) Significantly
affect the protection of investors or the public interest; (ii) impose
any significant burden on competition; and (iii) become operative for
30 days from the date on which it was filed, or such shorter time as
the Commission may designate, it has become effective pursuant to
Section 19(b)(3)(A) of the Act \17\ and Rule 19b-4(f)(6)
thereunder.\18\
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    \17\ 15 U.S.C. 78s(b)(3)(A).
    \18\ 17 CFR 240.19b-4(f)(6).
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    At any time within 60 days of the filing of a rule change pursuant
to Section 19(b)(3)(A) of the Act, the Commission may summarily
abrogate the rule change if it appears to the Commission that such
action is necessary or appropriate in the public interest, for the
protection of investors, or otherwise in furtherance of the purposes of
the Act.

IV. Solicitation of Comments

    Interested persons are invited to submit written data, views, and
arguments concerning the foregoing, including whether the proposed rule
change, as amended, is consistent with

the Act. Comments may be submitted by any of the following methods:

Electronic Comments

     Use the Commission's Internet comment form (http://www.sec.gov/rules/sro.shtml.
); or     Send an e-mail to<EMAIL_ADDRESS>Please include

File Number SR-NASDAQ-2006-036 on the subject line.

Paper Comments

     Send paper comments in triplicate to Nancy M. Morris,
Secretary, Securities and Exchange Commission, 100 F Street, NE.,
Washington, DC 20549-1090.

All submissions should refer to File Number SR-NASDAQ-2006-036. This
file number should be included on the subject line if e-mail is used.
To help the Commission process and review your comments more
efficiently, please use only one method. The Commission will post all
comments on the Commission's Internet Web site (http://www.sec.gov/rules/sro.shtml
). Copies of the submission, all subsequent amendments,

all written statements with respect to the proposed rule change that
are filed with the Commission, and all written communications relating
to the proposed rule change between the Commission and any person,
other than those that may be withheld from the public in accordance
with the provisions of 5 U.S.C. 552, will be available for inspection
and copying in the Commission's Public Reference Section, 100 F Street,
NE., Washington, DC 20549. Copies of such filing also will be available
for inspection and copying at the principal office of the NASD. All
comments received will be posted without change; the Commission does
not edit personal identifying information from submissions. You should
submit only information that you wish to make available publicly. All
submissions should refer to File Number SR-NASDAQ-2006-036 and should
be submitted on or before December 6, 2006.
    For the Commission, by the Division of Market Regulation, pursuant
to delegated authority.\19\
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    \19\ 17 CFR 200.30-3(a)(12).\

Nancy M. Morris,
Secretary.
[FR Doc. E6-19206 Filed 11-14-06; 8:45 am]

BILLING CODE 8011-01-P


[Federal Register Volume 81, Number 122 (Friday, June 24, 2016)]
[Notices]
[Page 41301]
[FR Doc No: 2016-15003]

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

[FRL-9948-23-Region 5]

EPA Great Lakes Advisory Board; Notice of Charter Renewal

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice of charter renewal.

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    Notice is hereby given that the Environmental Protection Agency
(EPA) has determined that, in accordance with the provisions of the
Federal Advisory Committee Act (FACA), 5 U.S.C. App. 2, the EPA Great
Lakes Advisory Board (GLAB) is a necessary committee which is in the
public interest. Accordingly, GLAB will be renewed for an additional
two-year period. The purpose of the GLAB is to provide advice to the
Administrator in her capacity as Chair of the Inter-Agency Task Force
established per Executive Order 13340 (May 18, 2004), on matters
related to Great Lakes restoration and protection. The GLAB's major
objectives are to provide advice and recommendations on: Great Lakes
protection and restoration policy; long term goals and objectives for
Great Lakes protection and restoration; annual priorities to protect
and restore the Great Lakes that may be used to help inform budget
decisions; and issues addressed by the Great Lakes Interagency Task
Force. Inquiries may be directed to Rita Cestaric, U.S. Environmental
Protection Agency, 77 W. Jackson, Chicago, IL 60604, Email address:
<EMAIL_ADDRESS>Telephone number:<PHONE_NUMBER>.

    Dated: May 3, 2016.
Cameron Davis,
Senior Advisor.
[FR Doc. 2016-15003 Filed 6-23-16; 8:45 am]
 BILLING CODE 6560-50-P


[Federal Register: March 11, 2008 (Volume 73, Number 48)]
[Proposed Rules]
[Page 12901-12905]
[DOCID:fr11mr08-17]

========================================================================
Proposed Rules
                                                Federal Register
________________________________________________________________________

This section of the FEDERAL REGISTER contains notices to the public of
the proposed issuance of rules and regulations. The purpose of these
notices is to give interested persons an opportunity to participate in
the rule making prior to the adoption of the final rules.

========================================================================

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2008-0265; Directorate Identifier 2007-NM-349-AD]
RIN 2120-AA64

Airworthiness Directives; Bombardier Model CL-600-2B19 (Regional
Jet Series 100 & 440) Airplanes

AGENCY: Federal Aviation Administration (FAA), Department of
Transportation (DOT).

ACTION: Notice of proposed rulemaking (NPRM).

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SUMMARY: The FAA proposes to supersede an existing airworthiness
directive (AD) that applies to certain Bombardier Model CL-600-2B19
airplanes. The existing AD currently requires repetitive eddy current
inspections for cracking of the main landing gear (MLG) main fittings,
and replacement with new or serviceable MLG main fittings if necessary.
The existing AD also currently requires servicing the MLG shock struts;
inspecting the MLG shock struts for nitrogen pressure, visible chrome
dimension, and oil leakage; and performing corrective actions, if
necessary. This proposed AD would require replacement of the MLG main
fittings with new improved MLG main fittings, which would terminate the
repetitive inspections of the MLG main fittings and inspection and
servicing of the MLG shock struts. This proposed AD results from
premature failure of the MLG main fittings. We are proposing this AD to
prevent failure of the MLG main fittings, which could result in
collapse of the MLG upon landing.

DATES: We must receive comments on this proposed AD by April 10, 2008.

ADDRESSES: You may send comments by any of the following methods:
     Federal eRulemaking Portal: Go to http://
www.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: U.S. Department of Transportation, Docket
Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New
Jersey Avenue SE., Washington, DC 20590, between 9 a.m. and 5 p.m.,
Monday through Friday, except Federal holidays.
    For service information identified in this AD, contact Bombardier,
Inc., Canadair, Aerospace Group, P.O. Box 6087, Station Centre-ville,
Montreal, Quebec H3C 3G9, Canada.

Examining the AD Docket

    You may examine the AD docket on the Internet at http://
www.regulations.gov; or in person at the Docket Management Facility
between 9 a.m. and 5 p.m., Monday through Friday, except Federal
holidays. The AD docket contains this proposed AD, the regulatory
evaluation, any comments received, and other information. The street
address for the Docket Office (telephone<PHONE_NUMBER>) is in the
ADDRESSES section. Comments will be available in the AD docket shortly
after receipt.

FOR FURTHER INFORMATION CONTACT: Pong K. Lee, Aerospace Engineer,
Airframe and Propulsion Branch, ANE-171, FAA, New York Aircraft
Certification Office, 1600 Stewart Avenue, Suite 410, Westbury, New
York 11590; telephone<PHONE_NUMBER>; fax<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Comments Invited

    We invite you to send any written relevant data, views, or
arguments about this proposed AD. Send your comments to an address
listed under the ADDRESSES section. Include ``Docket No. FAA-2008-0265;
Directorate Identifier 2007-NM-349-AD'' at the beginning of your
comments. We specifically invite comments on the overall regulatory,
economic, environmental, and energy aspects of this proposed AD. We
will consider all comments received by the closing date and may amend
this proposed AD because of those comments.
    We will post all comments we receive, without change, to http://
www.regulations.gov, including any personal information you provide. We
will also post a report summarizing each substantive verbal contact we
receive about this proposed AD.

Discussion

    On May 20, 2003, we issued AD 2003-11-11, amendment 39-13170 (68 FR
31956, May 29, 2003), for certain Bombardier Model CL-600-2B19
airplanes. That AD requires repetitive eddy current inspections for
cracking of the main landing gear (MLG) main fittings, and replacement
with new or serviceable MLG main fittings if necessary. That AD also
requires servicing the MLG shock struts; inspecting the MLG shock
struts for nitrogen pressure, visible chrome dimension, and oil
leakage; and performing corrective actions, if necessary. That AD
resulted from issuance of mandatory continuing airworthiness
information by a foreign civil airworthiness authority. We issued that
AD to prevent failure of the MLG main fittings, which could result in
collapse of the MLG upon landing.

Actions Since Existing AD Was Issued

    Since we issued AD 2003-11-11, Transport Canada Civil Aviation
(TCCA), which is the airworthiness authority for Canada, notified us
that it has certified a new design of the MLG main fitting.
Installation of the new improved MLG main fittings would eliminate the
need for the repetitive inspections of the MLG main fittings and the
inspection and servicing of the MLG shock struts.
    The preamble to AD 2003-11-11 explains that we consider the
requirements ``interim action'' and were considering further
rulemaking. We now have determined that further rulemaking is indeed
necessary, and this proposed AD follows from that determination.

Other Related Rulemaking

    On December 21, 2006, we issued AD 2007-01-07, amendment 39-14879
(72 FR 1430, January 12, 2007), for Model CL-600-2B19 (Regional Jet
Series 100 & 440) airplanes having serial numbers (S/Ns) 7003 through
7067 inclusive and S/Ns 7069 through 8999 inclusive, equipped with MLG
main fittings having part number (P/N) 601R85001-3 or -4 (Messier-Dowty
P/N 17064-101, -102, -103, or -104). That AD requires

repetitive inspections for cracks, sealant damage, and corrosion of the
main fittings of the MLG, and corrective actions if necessary. That AD
also requires replacement of both main fittings of the MLG with new
main fittings, which terminates the repetitive inspections. That AD
resulted from a report of a cracked main fitting of the MLG. We issued
that AD to detect and correct fatigue cracking of the main fitting of
the MLG and consequent failure of the main fitting, which could result
in the collapse of the MLG. For certain airplanes, accomplishing the
replacements in accordance with paragraph (l) of AD 2007-01-07 is
considered acceptable for compliance with the replacement specified in
this proposed AD.
    On January 29, 2007, we issued AD 2007-03-19, amendment 39-14930
(72 FR 5925, February 8, 2007), for certain Model CL-600-2B19 (Regional
Jet Series 100 & 440) airplanes having S/Ns 7003 and subsequent,
equipped with MLG main fittings having P/N 601R85001-81 and -82
(Messier-Dowty P/N 17064-105 and -106). That AD requires repetitive
detailed and eddy current inspections of the main fittings of the MLGs
to detect discrepancies, and related investigative/corrective actions
if necessary. That AD also requires servicing the shock strut of the
MLGs; inspecting the shock strut of the MLGs for nitrogen pressure,
visible chrome dimension, and oil leakage; and servicing any discrepant
strut. That AD also requires installing a new improved MLG main
fitting, which terminates the repetitive inspections and servicing
requirements. That AD resulted from stress analyses that showed certain
main fittings of the MLG are susceptible to premature cracking,
starting in the radius of the upper lug. We issued that AD to detect
and correct premature cracking of the main fittings of the MLGs, which
could result in failure of the fittings and consequent collapse of the
MLGs during landing. The requirements of AD 2007-03-19 do not affect
the actions specified in this proposed AD, since AD 2007-03-19 is
applicable to airplanes equipped with different MLG main fittings.

Relevant Service Information

    Bombardier has issued Service Bulletin 601R-32-093, Revision B,
dated July 14, 2005. The service bulletin describes procedures for
replacing the MLG main fittings with new improved MLG main fittings
having P/Ns 601R85001-83 and -84 (Messier-Dowty P/Ns 17064-107 and -
108). Accomplishing the actions specified in the service information is
intended to adequately address the unsafe condition. TCCA mandated the
service information and issued Canadian airworthiness directive CF-
1999-32R3, dated September 21, 2005, to ensure the continued
airworthiness of these airplanes in Canada.

FAA's Determination and Requirements of the Proposed AD

    These airplanes are manufactured in Canada and are type
certificated for operation in the United States under the provisions of
section 21.29 of the Federal Aviation Regulations (14 CFR 21.29) and
the applicable bilateral airworthiness agreement. Pursuant to this
bilateral airworthiness agreement, TCCA has kept the FAA informed of
the situation described above. We have examined TCCA's findings,
evaluated all pertinent information, and determined that AD action is
necessary for airplanes of this type design that are certificated for
operation in the United States.
    This proposed AD would supersede AD 2003-11-11 and would retain the
requirements of the existing AD. This proposed AD would also require
accomplishing the actions specified in the service information
described previously, except as discussed under ``Difference Between
the Proposed AD and Canadian Airworthiness Directive.''

Difference Between the Proposed AD and Canadian Airworthiness Directive

    Canadian airworthiness directive CF-1999-32R3 specifies replacing
the MLG main fittings by June 30, 2007, which is a compliance time of
about 21 months after issuance of Canadian airworthiness directive CF-
1999-32R3. This proposed AD, however, would require replacing the MLG
main fittings within 6 months after the effective date of the AD. In
developing an appropriate compliance time for this proposed AD, we
considered not only the manufacturer's recommendation, but the degree
of urgency associated with addressing the subject unsafe condition, the
average utilization of the affected fleet, and the time necessary to
perform the replacements. In light of all of these factors, we find a
compliance time of 6 months for completing the required actions to be
warranted, in that it represents an appropriate interval of time for
affected airplanes to continue to operate without compromising safety.
This difference has been coordinated with TCCA.

Change to Existing AD

    This proposed AD would retain all requirements of AD 2003-11-11.
Since AD 2003-11-11 was issued, the AD format has been revised, and
certain paragraphs have been rearranged. As a result, the corresponding
paragraph identifiers have changed in this proposed AD, as listed in
the following table:

                      Revised Paragraph Identifiers
------------------------------------------------------------------------
                                           Corresponding requirement in
      Requirement in AD 2003-11-11               this proposed  AD
------------------------------------------------------------------------
Paragraph (a)...........................  Paragraph (f).
Paragraph (b)...........................  Paragraph (g).
Paragraph (c)...........................  Paragraph (h).
Paragraph (d)...........................  Paragraph (i).
Paragraph (e)...........................  Paragraph (j).
Paragraph (f)...........................  Paragraph (k).
Paragraph (g)...........................  Paragraph (l).
Paragraph (h)...........................  Paragraph (m).
Paragraph (i)...........................  Paragraph (n).
Paragraph (j)...........................  Paragraph (o).
Paragraph (k)...........................  Paragraph (p).
Paragraph (l)...........................  Paragraph (q).
------------------------------------------------------------------------

Costs of Compliance

    The following table provides the estimated costs, at an average
labor rate of $80 per work hour, for U.S. operators to comply with this
proposed AD. Due to other existing ADs, the proposed actions have
already been accomplished on the majority of affected U.S.-registered
airplanes; therefore, the estimated costs will be significantly less
than those specified in the table.

                                                 Estimated Costs
----------------------------------------------------------------------------------------------------------------
                                                                                Number of U.S.-
            Action               Work hours         Parts           Cost per       registered       Fleet cost
                                                                    airplane        airplanes
----------------------------------------------------------------------------------------------------------------
Detailed inspection (required               1  None...........  $80, per                    618  $49,440, per
 by AD 2003-11-11).                                              inspection                       inspection
                                                                 cycle.                           cycle
Eddy current inspection                     1  None...........  $80, per                    618  $49,440, per
 (required by AD 2003-11-11).                                    inspection                       inspection
                                                                 cycle.                           cycle
Fluorescent penetrant                       1  None...........  $80, per                    618  $49,440, per
 inspection (required by AD                                      inspection                       inspection
 2003-11-11).                                                    cycle.                           cycle
Inspection and servicing of                 2  None...........  $160, per                   618  $98,880, per
 shock struts (required by AD                                    inspection                       inspection
 2003-11-11).                                                    cycle.                           cycle
Replacement (new proposed                  56  Up to $35,000..  Up to $39,480..             618  $24,398,640
 action).
----------------------------------------------------------------------------------------------------------------

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.
    We are 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

    We have determined that this proposed AD would not have federalism
implications under Executive Order 13132. This proposed AD would 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 the proposed
regulation:
    1. Is not a ``significant regulatory action'' under Executive Order
12866;
    2. Is not a ``significant rule'' under the DOT Regulatory Policies
and Procedures (44 FR 11034, February 26, 1979); and
    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.
    We prepared a regulatory evaluation of the estimated costs to
comply with this proposed AD and placed it in the AD docket. See the
ADDRESSES section for a location to examine the regulatory evaluation.

List of Subjects in 14 CFR Part 39

    Air transportation, Aircraft, Aviation safety, Safety.

The Proposed Amendment

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

PART 39--AIRWORTHINESS DIRECTIVES

    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]

    2. The Federal Aviation Administration (FAA) amends Sec.  39.13 by
removing amendment 39-13170 (68 FR 31956, May 29, 2003) and adding the
following new airworthiness directive (AD):
Bombardier, Inc. (Formerly Canadair): Docket No. FAA-2008-0265;
Directorate Identifier 2007-NM-349-AD.

Comments Due Date

    (a) The FAA must receive comments on this AD action by April 10,
2008.

Affected ADs

    (b) This AD supersedes AD 2003-11-11.

Applicability

    (c) This AD applies to Bombardier Model CL-600-2B19 (Regional
Jet Series 100 & 440) airplanes, certificated in any category;
having serial numbers (S/Ns) 7003 and subsequent, equipped with main
landing gear (MLG) main fittings having part numbers (P/Ns)
601R85001-3 and -4 (Messier-Dowty P/Ns 17064-101, -102, -103, and -
104).

Unsafe Condition

    (d) This AD results from premature failure of the MLG main
fittings. We are issuing this AD to prevent failure of the MLG main
fittings, which could result in collapse of the MLG upon landing.

Compliance

    (e) You are responsible for having the actions required by this
AD performed within the compliance times specified, unless the
actions have already been done.

    Note 1: Where there are differences between the referenced
service bulletin and the AD, the AD prevails.

Restatement of Requirements of AD 2003-11-11

Service Bulletin References

    (f) Accomplishment of the inspections and servicing, as applicable,
specified in paragraphs (h), (l), (m), and (n) of this AD, per
Bombardier Alert Service Bulletin A601R-32-079, dated December 3, 1999;
Revision `A,' dated January 7, 2000; Revision `B,' dated June 1, 2000;
Revision `C,' dated October 26, 2000; or Revision `D,' dated December
1, 2000; prior to June 13, 2003 (the effective date of AD 2003-11-11),
is considered acceptable for compliance with the requirements of
paragraphs (h), (l), (m), and (n) of this AD.
    (g) The term ``service bulletin,'' as used in paragraphs (h)
through (q) of this AD, means the Accomplishment Instructions of
Bombardier Alert Service Bulletin A601R-32-079, Revision `E,' dated
September 12, 2002; including Appendix 1, Revision D, dated September
12, 2002; including Appendices 2 and 3, dated September 12, 2002.

Initial Eddy Current Inspection

    (h) Perform an eddy current inspection to detect cracking of the
MLG main fittings, per PART B of the service bulletin, at the earlier
of the times specified in paragraph (h)(1) or (h)(2) of this AD.
    (1) Prior to the accumulation of 1,500 total flight cycles on the
MLG, or within 150 flight cycles after December 4, 2001

(the effective date of AD 2001-22-09, amendment 39-12488, which was
superseded by AD 2003-11-11), whichever occurs later.
    (2) Prior to the accumulation of 1,000 total flight cycles on the
MLG, or within 150 flight cycles after June 13, 2003, whichever occurs
later.

Repetitive Eddy Current Inspections

    (i) Repeat the eddy current inspection specified in paragraph (h)
of this AD at the time specified in paragraph (i)(1), (i)(2), or
(i)(3), as applicable, except as provided by paragraph (i)(4) of this
AD, per PART B of the service bulletin.
    (1) For airplanes on which the eddy current inspection required by
paragraph (g) of this AD is accomplished after June 13, 2003: Repeat
the inspection at intervals not to exceed 500 flight cycles.
    (2) For airplanes on which the repetitive eddy current inspection
required by AD 2001-22-09 has been accomplished, and on which the
repetitive intervals have been increased per paragraph (j) of AD 2001-
22-09 before June 13, 2003: Repeat the inspection within 500 flight
cycles after June 13, 2003, or within 1,000 flight cycles since the
last eddy current inspection, whichever occurs first, and thereafter at
intervals not to exceed 500 flight cycles.
    (3) For airplanes on which the repetitive eddy current inspection
required by AD 2001-22-09 has been accomplished, and on which the
repetitive intervals have not been increased per paragraph (j) of AD
2001-22-09 before June 13, 2003: Repeat the eddy current inspection at
intervals not to exceed 500 flight cycles.
    (4) For airplanes on which an eddy current inspection has been
accomplished to confirm the detailed inspection required by paragraph
(o) of this AD: The next eddy current inspection must be done within
500 flight cycles following the last detailed inspection required by
paragraph (o) of this AD, and thereafter at intervals not to exceed 500
flight cycles.

Corrective Actions

    (j) If no cracking of the MLG main fittings is suspected during the
next eddy current inspection required by paragraph (h) or (i) of this
AD, but the paint has been removed: Prior to further flight, apply a
new finish and install the harness clamp on the brake line with the
bolt, washers, nut, and cotter pin; per PART B of the service bulletin.
    (k) If any cracking of the MLG main fittings is found during any
eddy current inspection required by paragraph (h) or (i) of this AD:
Prior to further flight, replace any cracked MLG main fitting with a
new or serviceable part per the service bulletin.

Servicing the Shock Struts

    (l) Prior to the accumulation of 1,500 total flight cycles on the
MLG shock struts, or within 500 flight cycles after December 4, 2001,
whichever occurs later: Service (Oil and Nitrogen) the left and right
MLG shock struts per PART C (for airplanes on the ground) or PART D
(for airplanes on jacks) of the service bulletin.

Other Inspections

    (m) Within 500 flight cycles after completing the actions required
by paragraph (l) of this AD: Inspect the MLG left and right shock
struts for nitrogen pressure, visible chrome dimension, and oil
leakage, in accordance with PART E of the service bulletin. Thereafter,
repeat the inspection at intervals not to exceed 500 flight cycles.

Corrective Actions for Certain Inspections

    (n) If the chrome extension dimension of the shock strut pressure
reading is outside the limits specified in the Airplane Maintenance
Manual, Task 32-11-05-220-801, or any oil leakage is found during any
inspection required by paragraph (m) of this AD: Prior to further
flight, service the MLG shock strut in accordance with PART C (for
airplanes on the ground) or PART D (for airplanes on jacks) of the
service bulletin.

Detailed and Follow-On Inspections and Corrective Action

    (o) Prior to the accumulation of 1,000 total flight cycles on the
MLG, or within 250 flight cycles after June 13, 2003, whichever occurs
later: Accomplish a detailed inspection of the MLG main fittings to
detect signs of cracking (including linear paint cracks along the
circumference of the main fitting tube, lack of paint (paint peeling)
or other paint damage, lack of adhesion or paint bulging, and signs of
corrosion), per PART A of the service bulletin. Repeat the inspection
thereafter at intervals not to exceed 100 flight cycles.

    Note 2: For the purposes of this AD, a detailed inspection is
defined as: ``An intensive visual examination of a specific
structural area, system, installation, or assembly to detect damage,
failure, or irregularity. Available lighting is normally
supplemented with a direct source of good lighting at intensity
deemed appropriate by the inspector. Inspection aids such as mirror,
magnifying lenses, etc., may be used. Surface cleaning and elaborate
access procedures may be required.''

    (p) If any linear paint crack along the circumference of the main
fitting tube, lack of paint (paint peeling) or other paint damage,
evidence of paint bulging due to lack of adhesion, or evidence of
corrosion is found during any inspection required by paragraph (o) of
this AD: Prior to further flight, accomplish either an eddy current
inspection to detect cracking, per PART B of the service bulletin; or a
fluorescent penetrant inspection to detect cracking, per PART F of the
service bulletin.
    (1) If no cracking of the MLG main fittings is found during any
inspection required by paragraph (p) of this AD: Prior to further
flight, repaint and/or repair/rework any paint damage per PART B of the
service bulletin.
    (2) If any cracking of the MLG main fittings is found during any
inspection required by paragraph (p) of this AD: Prior to further
flight, replace any cracked MLG main fitting with a new or serviceable
part per the service bulletin.

Reporting Requirement

    (q) Within 30 days after each inspection and servicing required by
paragraphs (h), (i), (l), (m), (o), and (p) of this AD, report all
findings, positive or negative, to: Bombardier Aerospace, In-Service
Engineering, fax number<PHONE_NUMBER>. Although the service bulletin
references completion of a ``Service Bulletin Comment Sheet-Facsimile
Reply Sheet,'' this AD does not require that action. Information
collection requirements contained in this regulation have been approved
by the Office of Management and Budget (OMB) under the provisions of
the Paperwork Reduction Act of 1980 (44 U.S.C. 3501 et seq.) and have
been assigned OMB Control Number 2120-0056.

New Requirements of This AD

Replacement

    (r) Within 6 months after the effective date of this AD, replace
the MLG main fittings with new improved MLG main fittings, in
accordance with Bombardier Service Bulletin 601R-32-093, Revision B,
dated July 14, 2005. Replacing the MLG main fittings terminates the
requirements of paragraphs (h) through (q) of this AD.

Credit for Actions Done According to Previous Issues of the Service
Bulletin

    (s) Replacements done before the effective date of this AD in
accordance with Bombardier Service Bulletin 601R-32-093, dated October
17, 2003; or Revision A, dated September 21, 2004; are acceptable for
compliance with the requirements of paragraph (r) of this AD.

Credit for AD 2007-01-07

    (t) For airplanes having S/Ns 7003 through 7067 inclusive and S/Ns
7069 through 8999 inclusive, equipped with MLG main fittings having P/N
601R85001-3 or -4 (Messier-Dowty P/N 17064-101, -102, -103, or -104):
Accomplishing the replacements required by paragraph (l) of AD 2007-01-
07, amendment 39-14879, is acceptable for compliance with the
requirements of paragraph (r) of this AD.

Alternative Methods of Compliance (AMOCs)

    (u)(1) The Manager, New York Aircraft Certification Office (ACO),
FAA, has the authority to approve AMOCs for this AD, if requested in
accordance with the procedures found in 14 CFR 39.19.
    (2) To request a different method of compliance or a different
compliance time for this AD, follow the procedures in 14 CFR 39.19.
Before using any approved AMOC on any airplane to which the AMOC
applies, notify your appropriate principal inspector (PI) in the FAA
Flight Standards District Office (FSDO), or lacking a PI, your local
FSDO.
    (3) AMOCs issued to allow escalation of the repetitive intervals
for the eddy current inspections from 500 to 1,000 flight cycles in
accordance with paragraph (e) of AD 2001-22-09 are not approved as
AMOCs with this AD.

    Note 3: Information concerning the existence of AMOCs with this
AD, if any, may be obtained from the New York ACO.

Related Information

    (v) Canadian airworthiness directive CF-1999-32R3, dated September
21, 2005, also addresses the subject of this AD.

    Issued in Renton, Washington, on March 3, 2008.
Ali Bahrami,
Manager, Transport Airplane Directorate, Aircraft Certification
Service.
[FR Doc. E8-4769 Filed 3-10-08; 8:45 am]

BILLING CODE 4910-13-P