[Federal Register Volume 87, Number 182 (Wednesday, September 21, 2022)]
[Rules and Regulations]
[Pages 57615-57620]
[FR Doc No: 2022-20332]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2021-0153; FRL-10187-01-OCSPP]

Novaluron; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes tolerances for residues of
novaluron in or on multiple crops that are discussed later in this
document. Interregional Research Project Number 4 (IR-4) requested
these tolerances under the Federal Food, Drug, and Cosmetic Act
(FFDCA).

DATES: This regulation is effective September 21, 2022. Objections and
requests for hearings must be received on or before November 21, 2022,
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-2021-0153, is available at
https://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 and the OPP Docket is<PHONE_NUMBER>. For the latest
status information on EPA/DC services, docket access, visit https://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: Marietta Echeverria, Acting Director,
Registration Division (7505T), 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 EPA's
tolerance regulations at 40 CFR part 180 through the Office of the
Federal Register's e-CFR site at https://www.ecfr.gov/current/title-40.

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

    Under FFDCA section 408(g), 21 U.S.C. 346a(g), 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-2021-0153 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
November 21, 2022. 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-2021-0153, by one of
the following methods:
     Federal eRulemaking Portal: https://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 https://www.epa.gov/dockets/where-send-comments-epa-dockets.
    Additional instructions on commenting or visiting the docket, along
with more information about dockets generally, is available at https://www.epa.gov/dockets.

II. Summary of Petitioned-For Tolerance

    In the Federal Register of June 28, 2021 (86 FR 33922) (FRL-10025-
08), EPA issued a document pursuant to FFDCA section 408(d)(3), 21
U.S.C.

346a(d)(3), announcing the filing of a pesticide petition (PP 0E8882)
by IR-4, North Carolina State University, 1730 Varsity Drive, Venture
IV, Suite 210, Raleigh, NC 27606. The petition requested that 40 CFR
180.598 be amended by establishing tolerances for residues of the
insecticide novaluron in or on individual crops of proposed Crop
Subgroup 6-XXA: Edible podded bean legume vegetable subgroup at 0.7
parts per million (ppm); individual crops of proposed Crop Subgroup 6-
XXB: Edible podded pea legume vegetable subgroup at 2 ppm; individual
crops of Proposed Crop Subgroup 6-XXC: Succulent shelled bean subgroup
at 0.7 ppm; individual crops of Proposed Crop Subgroup 6-XXD: Succulent
shelled pea subgroup at 0.05 ppm; individual crops of Proposed Crop
Subgroup 6-XXE: Dried shelled bean, except soybean at 0.3 ppm;
individual crops of Proposed Crop Subgroup 6-XXF: Dried shelled pea
subgroup at 0.1 ppm; and Pea, forage at 15 ppm. The petition also
requested to amend 40 CFR part 180 by removing established tolerances
for residues of novaluron, including its metabolites and degradates, in
or on Bean, dry, seed at 0.30 ppm, and Bean, succulent at 0.70 ppm.
That document referenced a summary of the petition, which is available
in the docket, https://www.regulations.gov. One comment was received
from the United States Department of Agriculture in support of the
notice of filing.
    In the Federal Register of April 28, 2022 (87 FR 25178) (FRL-9410-
12-OCSPP) EPA issued a document pursuant to FFDCA section 408(d)(3), 21
U.S.C. 346a(d)(3), announcing the filing of a pesticide petition (PP
0E8882) by IR-4, North Carolina State University, 1730 Varsity Drive,
Venture IV, Suite 210, Raleigh, NC 27606. The petition requested that
40 CFR 180.598 be amended by establishing tolerances for residues of
the insecticide novaluron in or on the following raw agricultural
commodities: Bean, phaseolus, forage at 15 ppm; Cowpea, forage at 15
ppm; Pea, field, forage at 15 ppm; Bean, phaseolus, hay at 80 ppm;
Cowpea, hay at 80 ppm; and Pea, field, hay at 80 ppm. That document
referenced a summary of the petition, which is available in the docket,
https://www.regulations.gov. No substantive comments were received in
response to the notice.
    Based upon review of the data supporting the petition and in
accordance with its authority under FFDCA section 408(d)(4)(A)(i), EPA
is modifying many of the commodity definitions to be consistent with
Agency terminology. The tolerance levels being established are the same
as the petition requested.

III. Aggregate Risk Assessment and Determination of Safety

    Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish 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. . .
.''
    Consistent with FFDCA section 408(b)(2)(D), and the factors
specified therein, 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 novaluron including exposure resulting from the
tolerances established by this action. EPA's assessment of exposures
and risks associated with novaluron follows.
    In an effort to streamline its publications in the Federal
Register, EPA is not reprinting sections that repeat what has been
previously published for tolerance rulemakings for the same pesticide
chemical. Where scientific information concerning a particular chemical
remains unchanged, the content of those sections would not vary between
tolerance rulemakings, and EPA considers referral back to those
sections as sufficient to provide an explanation of the information EPA
considered in making its safety determination for the new rulemaking.
    EPA has previously published tolerance rulemakings for novaluron in
which EPA concluded, based on the available information, that there is
a reasonable certainty that no harm would result from aggregate
exposure to novaluron and established tolerances for residues of that
chemical. EPA is incorporating previously published sections from these
rulemakings as described further in this rulemaking, as they remain
unchanged.
    In addition, EPA has conducted a human health risk assessment in
support of registration review for novaluron. That document,
``Novaluron: Draft Human Health Risk Assessment to Support Registration
Review'' dated March 24, 2020, along with the Novaluron Interim
Registration Review Decision, are available in docket ID number EPA-HQ-
OPP-2015-0171 and are referenced below.
    Toxicological profile. For a discussion of the Toxicological
Profile of novaluron, see Unit III.A. of the novaluron tolerance
rulemaking published in the Federal Register of July 22, 2015 (80 FR
43329) (FRL-9929-57) as well as the Novaluron: Draft Human Health Risk
Assessment to Support Registration Review and Novaluron Interim
Registration Review Decision.
    Toxicological points of departure/Levels of concern. For a summary
of the Toxicological Points of Departure/Levels of Concern for
novaluron used for human health risk assessment, please reference Unit
III.B. of the July 22, 2015, rulemaking as well as the Novaluron: Draft
Human Health Risk Assessment to Support Registration Review and
Novaluron Interim Registration Review Decision.
    Exposure assessment. EPA's dietary exposure assessments have been
updated to include the additional exposure from the proposed new uses
of novaluron on the commodities identified in this action. An acute
dietary exposure assessment was not performed as there are no
toxicological effects attributable to a single exposure (dose). A
partially refined chronic dietary (food and drinking water) exposure
and risk assessment was conducted that incorporated tolerance-level
residues for the proposed new uses. The chronic dietary exposure and
risk assessment also incorporated average percent crop treated (PCT)
data for several registered commodities as well as projected PCT data
for the proposed Field Pea and Cowpea feed commodities. For the
remaining commodities, 100 PCT was assumed. Anticipated residues for
meat, milk, hog, and poultry commodities were incorporated as well. A
cancer dietary assessment was not conducted because novaluron is
classified as ``not likely to be carcinogenic to humans.''
    Anticipated residue and PCT information. Section 408(b)(2)(E) of
FFDCA authorizes EPA to use available data and information on the
anticipated residue levels of pesticide residues in food and the actual
levels of pesticide residues that have been measured in food. If EPA
relies on such information,

EPA must require pursuant to FFDCA section 408(f)(1) that data be
provided 5 years after the tolerance is established, modified, or left
in effect, demonstrating that the levels in food are not above the
levels anticipated. For the present action, EPA will issue such data
call-ins as are required by FFDCA section 408(b)(2)(E) and authorized
under FFDCA section 408(f)(1). Data will be required to be submitted no
later than 5 years from the date of issuance of these tolerances.
    Section 408(b)(2)(F) of FFDCA states that the Agency may use data
on the actual percent of food treated for assessing chronic dietary
risk only if:
     Condition a: The data used are reliable and provide a
valid basis to show what percentage of the food derived from such crop
is likely to contain the pesticide residue.
     Condition b: The exposure estimate does not underestimate
exposure for any significant subpopulation group.
     Condition c: Data are available on pesticide use and food
consumption in a particular area, and the exposure estimate does not
understate exposure for the population in such area.
    In addition, the Agency must provide for periodic evaluation of any
estimates used. To provide for the periodic evaluation of the estimate
of PCT as required by FFDCA section 408(b)(2)(F), EPA may require
registrants to submit data on PCT.
    Updated average percent crop treated values were used for the
following crops that are currently registered for novaluron: apples
(10%), broccoli (1%), cabbage (5%), cantaloupe (1%), cauliflower (1%),
cherries (1%), cotton (5%), dry beans/peas (1%), peaches (1%), peanuts
(5%), pears (25%), peppers (5%), plums/prunes (1%), potatoes (5%),
pumpkins (1%), sorghum (1%), squash (1%), strawberries (45%), sugarcane
(1%), sweet corn (1%), tomatoes (2.5%), and watermelons (1%).
    In most cases, EPA uses available data from the United States
Department of Agriculture/National Agricultural Statistics Service
(USDA/NASS), proprietary market surveys, and California Department of
Pesticide Regulation (CalDPR) Pesticide Use Reporting (PUR) for the
chemical/crop combination for the most recent 10 years. EPA uses an
average PCT for chronic dietary risk analysis and a maximum PCT for
acute dietary risk analysis. The average PCT figure for each existing
use is derived by combining available public and private market survey
data for that use, averaging across all observations, and rounding to
the nearest 5%, except for those situations in which the average PCT is
less than 1% or less than 2.5% as the average PCT value, respectively.
In those cases, the Agency would use less than 1% or less than 2.5% as
the average PCT value, respectively. The maximum PCT figure is the
highest observed maximum value reported within the most recent 10 years
of available public and private market survey data for the existing use
and rounded up to the nearest multiple of 5%, except where the maximum
PCT is less than 2.5%, in which case, the Agency uses less than 2.5% as
the maximum PCT.
    Projected PCT was used for Field Pea and Cowpea feed commodities
(10%). EPA estimates the projected PCT, also known as the percent crop
treated of a new use (PCTn), based on the PCT of the dominant pesticide
(i.e., the one with the greatest PCT) used on that crop over the three
most recent years of available data. Comparisons are only made among
pesticides of the same pesticide types (e.g., the dominant insecticide
on the crop is selected for comparison with a new insecticide). The
PCTs included in the analysis may be for the same pesticide or for
different pesticides since the same or different pesticides may
dominate for each year. Typically, EPA uses USDA NASS as the source for
raw PCT data because it is publicly available and does not have to be
calculated from available data sources. When a specific use site is not
surveyed by USDA NASS, EPA uses other appropriate public data or
private market research to calculate the PCTn.
    The average PCT of the market leader(s) is appropriate for use in
the chronic dietary risk assessment. This method of estimating a PCT
for a new use of a registered pesticide or a new pesticide produces a
high-end estimate that is unlikely, in most cases, to be exceeded
during the initial five years of actual use. The predominant factors
that bear on whether the estimated PCTn could be exceeded are (1) the
extent of pest pressure on the crops in question; (2) the pest spectrum
of the new pesticide in comparison with the market; and (3) resistance
concerns with the market leaders. EPA has examined the relevant data
and concludes that it is unlikely that the actual PCT with novaluron on
the Field Pea and Cowpea feed commodities will exceed the PCTn within
the next 5 years.
    The Agency believes that Conditions a, b, and c discussed above
have been met. With respect to Condition a, PCT estimates are derived
from Federal and private market survey data, which are reliable and
have a valid basis. The Agency is reasonably certain that the
percentage of the food treated is not likely to be an underestimation.
As to Conditions b and c, regional consumption information and
consumption information for significant subpopulations is taken into
account through EPA's computer-based model for evaluating the exposure
of significant subpopulations including several regional groups. Use of
this consumption information in EPA's risk assessment process ensures
that EPA's exposure estimate does not understate exposure for any
significant subpopulation group and allows the Agency to be reasonably
certain that no regional population is exposed to residue levels higher
than those estimated by the Agency. Other than the data available
through national food consumption surveys, EPA does not have available
reliable information on the regional consumption of food to which
novaluron may be applied in a particular area.
    Drinking water and non-occupational exposures. The previously
recommended estimated drinking water concentrations (EDWCs) remain
current and are considered protective potential drinking water residue
levels anticipated from the proposed tolerances. As stated in Unit III
of the novaluron tolerance rulemaking published in the Federal Register
of August 13, 2020 (85 FR 49261) (FRL-10011-78), the chronic dietary
exposure and risk assessment incorporate the highest total estimated
drinking water concentration (EDWC) of 8.4 parts per billion directly
into this dietary assessment. The residential exposure assessment has
not changed since the July 22, 2015, rulemaking because there are no
proposed new residential uses. For a summary of the residential
exposure analysis for novaluron used for the human health risk
assessment, please reference Unit III.C.3. of the July 22, 2015,
rulemaking.
    Cumulative exposure. 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.'' Unlike other
pesticides for which EPA has followed a cumulative risk approach based
on a common mechanism of toxicity, EPA has not made a common mechanism
of toxicity finding as to novaluron and any other substances and
novaluron does not appear to produce a toxic metabolite produced by
other substances. For the purposes of this action, therefore, EPA has
not assumed that novaluron has a common

mechanism of toxicity with other substances.
    Safety factor for infants and children. EPA continues to conclude
that there are reliable data to support the reduction of the Food
Quality Protection Act (FQPA) safety factor from 10X to 1X. See Unit
III.D. of the July 22, 2015, rulemaking for a discussion of the
Agency's rationale for that determination.
    Aggregate risks and determination of safety. EPA determines whether
acute and chronic dietary pesticide exposures are safe by comparing
aggregate exposure estimates to the acute population-adjusted dose
(aPAD) and chronic population-adjusted dose (cPAD). Short-,
intermediate-, and chronic-term risks are evaluated by comparing the
estimated aggregate food, water, and residential exposure to the
appropriate points of departure to ensure that an adequate margin of
exposure (MOE) exists. For linear cancer risks, EPA calculates the
lifetime probability of acquiring cancer given the estimated aggregate
exposure.
    An acute dietary exposure assessment was not performed as there
were no toxicological effects attributable to a single exposure (dose)
observed in available oral toxicity studies, including maternal
toxicity in the developmental toxicity studies. Chronic dietary risks
are below the Agency's level of concern of 100% of the cPAD; they are
29% of the cPAD for children 1 to 2 years old, the group with the
highest exposure. The combined short- and intermediate-term food,
water, and residential exposures result in aggregate margins of
exposures of 3,800 for adults and 280 for children 1 to 2 years old.
These MOEs are greater than the level of concern of 100 and are
therefore not of concern. Novaluron is classified as ``Not Likely to Be
Carcinogenic to Humans''; therefore, EPA does not expect novaluron
exposures to pose an aggregate cancer risk.
    Therefore, based on the risk assessments and information described
above, EPA concludes there is a reasonable certainty that no harm will
result to the general population, or to infants and children, from
aggregate exposure to novaluron residues. More detailed information on
this action can be found in the document titled ``Novaluron. Human
Health Risk Assessment for Petition for Individual Commodities of
Proposed Crop Subgroup 6-XXA: Vegetable, legume, bean, edible podded,
subgroup 6-xxA; Proposed Crop Subgroup 6-XXB: Vegetable, legume, pea,
edible podded, subgroup 6-xxB; Proposed Crop Subgroup 6-XXC: Vegetable,
legume, bean, succulent shelled, subgroup 6-xxC; Proposed Crop Subgroup
6-XXD: Vegetable, legume, pea, succulent shelled, subgroup 6-xxD;
Proposed Crop Subgroup 6-XXE: Vegetable, legume, bean, dried shelled,
subgroup 6-xxE; Proposed Crop Subgroup 6-XXF: Vegetable, legume, pea,
dried shelled, subgroup 6-xxF; Proposed Crop Subgroup 7-XXA: Vegetable,
legume, forage and hay, except soybean group 7-xxA, forage; and
Proposed Crop Subgroup 7-XXA: Vegetable, legume, forage and hay, except
soybean group 7-xxA, hay'' in docket ID EPA-HQ-OPP-2021-0153.

IV. Other Considerations

A. Analytical Enforcement Methodology

    For a discussion of the available analytical enforcement method,
see Unit IV.A. of the July 22, 2015, rulemaking.

B. International Residue Limits

    In making its tolerance decisions, EPA seeks to harmonize U.S.
tolerances with international standards whenever possible, consistent
with U.S. food safety standards and agricultural practices. EPA
considers the international maximum residue limits (MRLs) established
by the Codex Alimentarius Commission (Codex), as required by FFDCA
section 408(b)(4).
    The U.S. and Codex levels are harmonized for edible-podded and
succulent shelled beans at 0.7 ppm. Using the Organization for Economic
Cooperation and Development (OECD) calculator for the dried shelled
beans, except soybean, subgroup gives a recommended tolerance level of
0.3 ppm, which is higher than the established Codex MRL of 0.1 ppm for
``beans (dry).'' The Agency is not lowering the tolerance level to
harmonize with Codex because doing so could cause U.S. growers to have
violative residues despite legal use of novaluron according to the
label. There are no Codex MRLs for any of the other commodities
identified in this action.

V. Conclusion

    Therefore, tolerances are established for residues of novaluron in
or on Bean, adzuki, dry seed at 0.3 ppm; Bean, African yam, dry seed at
0.3 ppm; Bean, American potato, dry seed at 0.3 ppm; Bean, asparagus,
dry seed at 0.3 ppm; Bean, asparagus edible podded at 0.7 ppm; Bean,
black, dry seed at 0.3 ppm; Bean, broad, dry seed at 0.3 ppm; Bean,
broad, succulent shelled at 0.7 ppm; Bean, catjang, dry seed at 0.3
ppm; Bean, catjang edible podded at 0.7 ppm; Bean, catjang, succulent
shelled at 0.7 ppm; Bean, cranberry, dry seed at 0.3 ppm; Bean, dry
bean, dry seed at 0.3 ppm; Bean, field, dry seed at 0.3 ppm; Bean,
French, dry seed at 0.3 ppm; Bean, French, edible podded at 0.7 ppm;
Bean, garden, dry seed at 0.3 ppm; Bean, garden, edible podded at 0.7
ppm; Bean, goa, dry seed at 0.3 ppm; Bean, goa, edible podded at 0.7
ppm; Bean, goa, succulent shelled at 0.7 ppm; Bean, great northern, dry
seed at 0.3 ppm; Bean, green, dry seed at 0.3 ppm; Bean, green, edible
podded at 0.7 ppm; Bean, guar, dry seed at 0.3 ppm; Bean, guar, edible
podded at 0.7 ppm; Bean, horse gram, dry seed at 0.3 ppm; Bean, kidney,
dry seed at 0.3 ppm; Bean, kidney, edible podded at 0.7 ppm; Bean,
lablab, dry seed at 0.3 ppm; Bean, lablab, edible podded at 0.7 ppm;
Bean, lablab, succulent shelled at 0.7 ppm; Bean, lima, dry seed at 0.3
ppm; Bean, lima, succulent shelled at 0.7 ppm; Bean, morama, dry seed
at 0.3 ppm; Bean, moth, dry seed at 0.3 ppm; Bean, moth, edible podded
at 0.7 ppm; Bean, moth, succulent shelled at 0.7 ppm; Bean, mung, dry
seed at 0.3 ppm; Bean, mung, edible podded at 0.7 ppm; Bean, navy, dry
seed at 0.3 ppm; Bean, navy, edible podded at 0.7 ppm; Bean, phaseolus,
forage at 15 ppm; Bean, phaseolus, hay at 80 ppm; Bean, pink, dry seed
at 0.3 ppm; Bean, pinto, dry seed at 0.3 ppm; Bean, red, dry seed at
0.3 ppm; Bean, rice, dry seed at 0.3 ppm; Bean, rice, edible podded at
0.7 ppm; Bean, scarlet runner, dry seed at 0.3 ppm; Bean, scarlet
runner, edible podded at 0.7 ppm; Bean, scarlet runner, succulent
shelled at 0.7 ppm; Bean, snap, edible podded at 0.7 ppm; Bean, sword,
dry seed at 0.3 ppm; Bean, sword, edible podded at 0.7 ppm; Bean,
tepary, dry seed at 0.3 ppm; Bean, urd, dry seed at 0.3 ppm; Bean, urd,
edible podded at 0.7 ppm; Bean, wax, edible podded at 0.7 ppm; Bean,
wax, succulent shelled at 0.7 ppm; Bean, yardlong, dry seed at 0.3 ppm;
Bean, yardlong, edible podded at 0.7 ppm; Bean, yellow, dry seed at 0.3
ppm; Chickpea, dry seed at 0.1 ppm; Chickpea, edible podded at 2 ppm;
Chickpea, succulent shelled at 0.05 ppm; Cowpea, dry seed at 0.3 ppm;
Cowpea, edible podded at 0.7 ppm; Cowpea, forage at 15 ppm; Cowpea, hay
at 80 ppm; Cowpea, succulent shelled at 0.7 ppm; Jackbean, dry seed at
0.3 ppm; Jackbean, edible podded at 0.7 ppm; Jackbean, succulent
shelled at 0.7 ppm; Lentil, dry seed at 0.1 ppm; Lentil, edible podded
at 2 ppm; Lentil, succulent shelled at 0.05 ppm; Longbean, Chinese, dry
seed at 0.3 ppm; Longbean, Chinese, edible podded at 0.7 ppm; Lupin,
Andean, dry seed at 0.3 ppm; Lupin, Andean, succulent shelled

at 0.7 ppm; Lupin, blue, dry seed at 0.3 ppm; Lupin, blue, succulent
shelled at 0.7 ppm; Lupin, grain, dry seed at 0.3 ppm; Lupin, grain,
succulent shelled at 0.7 ppm; Lupin, sweet, dry seed at 0.3 ppm; Lupin,
sweet, succulent shelled at 0.7 ppm; Lupin, white sweet, dry seed at
0.3 ppm; Lupin, white sweet, succulent shelled at 0.7 ppm; Lupin,
white, dry seed at 0.3 ppm; Lupin, white, succulent shelled at 0.7 ppm;
Lupin, yellow, dry seed at 0.3 ppm; Lupin, yellow, succulent shelled at
0.7 ppm; Pea, blackeyed, dry seed at 0.3 ppm; Pea, blackeyed, succulent
shelled at 0.7 ppm; Pea, crowder, dry seed at 0.3 ppm; Pea, crowder,
succulent shelled at 0.7 ppm; Pea, dry, dry seed at 0.1 ppm; Pea,
dwarf, edible podded at 2 ppm; Pea, English, succulent shelled at 0.05
ppm; Pea, field, dry seed at 0.1 ppm; Pea, field, forage at 15 ppm;
Pea, field, hay at 80 ppm; Pea, garden, dry seed at 0.1 ppm; Pea,
garden, succulent shelled at 0.05 ppm; Pea, grass, dry seed at 0.1 ppm;
Pea, grass, edible podded at 2 ppm; Pea, green, dry seed at 0.1 ppm;
Pea, green, edible podded at 2 ppm; Pea, green, succulent shelled at
0.05 ppm; Pea, pigeon, dry seed at 0.1 ppm; Pea, pigeon, edible podded
at 2 ppm; Pea, pigeon, succulent shelled at 0.05 ppm; Pea, snap, edible
podded at 2 ppm; Pea, snow, edible podded at 2 ppm; Pea, southern, dry
seed at 0.3 ppm; Pea, southern, succulent shelled at 0.7 ppm; Pea,
sugar snap, edible podded at 2 ppm; Pea, winged, dry seed at 0.3 ppm;
Pea, winged, edible podded at 0.7 ppm; Soybean, vegetable, dry seed at
0.3 ppm; Soybean, vegetable, edible podded at 0.7 ppm; Soybean,
vegetable, succulent shelled at 0.7 ppm; Velvetbean, dry seed at 0.3
ppm; Velvetbean, edible podded at 0.7 ppm; Velvetbean, succulent
shelled at 0.7 ppm.
    Additionally, the established tolerances on Bean, dry, seed and
Bean, succulent are removed as unnecessary.

VI. Statutory and Executive Order Reviews

    This action establishes tolerances 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 to Executive Order 13045,
entitled ``Protection of Children from Environmental Health Risks and
Safety Risks'' (62 FR 19885, April 23, 1997). 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 tolerances 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).

VII. 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: September 15, 2022.
Marietta Echeverria,
Acting Director, Registration Division, Office of Pesticide Programs.

    Therefore, for the reasons stated in the preamble, EPA is amending
40 CFR chapter 1 as follows:

PART 180--TOLERANCES AND EXEMPTIONS FOR PESTICIDE CHEMICAL RESIDUES
IN FOOD

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.  180.598, amend the Table 1 to Paragraph (a) by:
0
a. Adding in alphabetical order the entries ``Bean, adzuki, dry seed'';
``Bean, African yam, dry seed''; ``Bean, American potato, dry seed'';
``Bean, asparagus, dry seed''; ``Bean, asparagus, edible podded'';
``Bean, black, dry seed''; ``Bean, broad, dry seed''; ``Bean, broad,
succulent shelled''; ``Bean, catjang, dry seed''; ``Bean, catjang
edible podded''; ``Bean, catjang, succulent shelled''; ``Bean,
cranberry, dry seed''; and ``Bean, dry bean, dry seed''.
0
b. Removing the entry for ``Bean, dry, seed''.
0
c. Adding in alphabetical order the entries ``Bean, field, dry seed'';
``Bean, French, dry seed''; ``Bean, French, edible podded''; ``Bean,
garden, dry seed''; ``Bean, garden, edible podded''; ``Bean, goa, dry
seed''; ``Bean, goa, edible podded''; ``Bean, goa, succulent shelled'';
``Bean, great northern, dry seed''; ``Bean, green, dry seed''; ``Bean,
green, edible podded''; ``Bean, guar, dry seed''; ``Bean, guar, edible
podded''; ``Bean, horse gram, dry seed''; ``Bean, kidney, dry seed'';
``Bean, kidney, edible podded''; ``Bean, lablab, dry seed''; ``Bean,
lablab, edible podded''; ``Bean, lablab, succulent shelled''; ``Bean,
lima, dry seed''; ``Bean, lima, succulent shelled''; ``Bean, morama,
dry seed''; ``Bean, moth, dry seed''; ``Bean, moth, edible podded'';
``Bean, moth, succulent shelled''; ``Bean, mung, dry seed''; ``Bean,
mung, edible podded''; ``Bean, navy, dry seed''; ``Bean, navy, edible
podded''; ``Bean, phaseolus, forage''; ``Bean, phaseolus, hay'';
``Bean, pink, dry seed''; ``Bean, pinto, dry seed''; ``Bean, red, dry
seed''; ``Bean, rice, dry

seed''; ``Bean, rice, edible podded''; ``Bean, scarlet runner, dry
seed''; ``Bean, scarlet runner, edible podded''; ``Bean, scarlet
runner, succulent shelled''; and ``Bean, snap, edible podded''.
0
d. Removing the entry for ``Bean, succulent''.
0
e. Adding in alphabetical order the entries ``Bean, sword, dry seed'';
``Bean, sword, edible podded''; ``Bean, tepary, dry seed''; ``Bean,
urd, dry seed''; ``Bean, urd, edible podded''; ``Bean, wax, edible
podded''; ``Bean, wax, succulent shelled''; ``Bean, yardlong, dry
seed''; ``Bean, yardlong, edible podded''; ``Bean, yellow, dry seed'';
``Chickpea, dry seed''; ``Chickpea, edible podded''; ``Chickpea,
succulent shelled''; ``Cowpea, dry seed''; ``Cowpea, edible podded'';
``Cowpea, forage''; ``Cowpea, hay''; ``Cowpea, succulent shelled'';
``Jackbean, dry seed''; ``Jackbean, edible podded''; ``Jackbean,
succulent shelled''; ``Lentil, dry seed''; ``Lentil, edible podded'';
``Lentil, succulent shelled''; ``Longbean, Chinese, dry seed'';
``Longbean, Chinese, edible podded''; ``Lupin, Andean, dry seed'';
``Lupin, Andean, succulent shelled''; ``Lupin, blue, dry seed'';
``Lupin, blue, succulent shelled''; ``Lupin, grain, dry seed'';
``Lupin, grain, succulent shelled''; ``Lupin, sweet, dry seed'';
``Lupin, sweet, succulent shelled''; ``Lupin, white sweet, dry seed'';
``Lupin, white sweet, succulent shelled''; ``Lupin, white, dry seed'';
``Lupin, white, succulent shelled''; ``Lupin, yellow, dry seed'';
``Lupin, yellow, succulent shelled''; ``Pea, blackeyed, dry seed'';
``Pea, blackeyed, succulent shelled''; ``Pea, crowder, dry seed'';
``Pea, crowder, succulent shelled''; ``Pea, dry, dry seed''; ``Pea,
dwarf, edible podded''; ``Pea, English, succulent shelled''; ``Pea,
field, dry seed''; ``Pea, field, forage''; ``Pea, field, hay''; ``Pea,
garden, dry seed''; ``Pea, garden, succulent shelled''; ``Pea, grass,
dry seed''; ``Pea, grass, edible podded''; ``Pea, green, dry seed'';
``Pea, green, edible podded''; ``Pea, green, succulent shelled'';
``Pea, pigeon, dry seed''; ``Pea, pigeon, edible podded''; ``Pea,
pigeon, succulent shelled''; ``Pea, snap, edible podded''; ``Pea, snow,
edible podded''; ``Pea, southern, dry seed''; ``Pea, southern,
succulent shelled''; ``Pea, sugar snap, edible podded''; ``Pea, winged,
dry seed''; ``Pea, winged, edible podded''; ``Soybean, vegetable, dry
seed''; ``Soybean, vegetable, edible podded''; ``Soybean, vegetable,
succulent shelled''; ``Velvetbean, dry seed''; ``Velvetbean, edible
podded''; and ``Velvetbean, succulent shelled''.
    The additions read as follows:

Sec.  180.598  Novaluron; tolerances for residues.

    (a) * * *

                        Table 1 to Paragraph (a)
------------------------------------------------------------------------
                                                                  Parts
                           Commodity                               per
                                                                 million
------------------------------------------------------------------------

                                * * * * *
Bean, adzuki, dry seed........................................       0.3
Bean, African yam, dry seed...................................       0.3
Bean, American potato, dry seed...............................       0.3
Bean, asparagus, dry seed.....................................       0.3
Bean, asparagus, edible podded................................       0.7
Bean, black, dry seed.........................................       0.3
Bean, broad, dry seed.........................................       0.3
Bean, broad, succulent shelled................................       0.7
Bean, catjang, dry seed.......................................       0.3
Bean, catjang edible podded...................................       0.7
Bean, catjang, succulent shelled..............................       0.7
Bean, cranberry, dry seed.....................................       0.3
Bean, dry bean, dry seed......................................       0.3
Bean, field, dry seed.........................................       0.3
Bean, French, dry seed........................................       0.3
Bean, French, edible podded...................................       0.7
Bean, garden, dry seed........................................       0.3
Bean, garden, edible podded...................................       0.7
Bean, goa, dry seed...........................................       0.3
Bean, goa, edible podded......................................       0.7
Bean, goa, succulent shelled..................................       0.7
Bean, great northern, dry seed................................       0.3
Bean, green, dry seed.........................................       0.3
Bean, green, edible podded....................................       0.7
Bean, guar, dry seed..........................................       0.3
Bean, guar, edible podded.....................................       0.7
Bean, horse gram, dry seed....................................       0.3
Bean, kidney, dry seed........................................       0.3
Bean, kidney, edible podded...................................       0.7
Bean, lablab, dry seed........................................       0.3
Bean, lablab, edible podded...................................       0.7
Bean, lablab, succulent shelled...............................       0.7
Bean, lima, dry seed..........................................       0.3
Bean, lima, succulent shelled.................................       0.7
Bean, morama, dry seed........................................       0.3
Bean, moth, dry seed..........................................       0.3
Bean, moth, edible podded.....................................       0.7
Bean, moth, succulent shelled.................................       0.7
Bean, mung, dry seed..........................................       0.3
Bean, mung, edible podded.....................................       0.7
Bean, navy, dry seed..........................................       0.3
Bean, navy, edible podded.....................................       0.7
Bean, phaseolus, forage.......................................        15
Bean, phaseolus, hay..........................................        80
Bean, pink, dry seed..........................................       0.3
Bean, pinto, dry seed.........................................       0.3
Bean, red, dry seed...........................................       0.3
Bean, rice, dry seed..........................................       0.3
Bean, rice, edible podded.....................................       0.7
Bean, scarlet runner, dry seed................................       0.3
Bean, scarlet runner, edible podded...........................       0.7
Bean, scarlet runner, succulent shelled.......................       0.7
Bean, snap, edible podded.....................................       0.7
Bean, sword, dry seed.........................................       0.3
Bean, sword, edible podded....................................       0.7
Bean, tepary, dry seed........................................       0.3
Bean, urd, dry seed...........................................       0.3
Bean, urd, edible podded......................................       0.7
Bean, wax, edible podded......................................       0.7
Bean, wax, succulent shelled..................................       0.7
Bean, yardlong, dry seed......................................       0.3
Bean, yardlong, edible podded.................................       0.7
Bean, yellow, dry seed........................................       0.3

                                * * * * *
Chickpea, dry seed............................................       0.1
Chickpea, edible podded.......................................         2
Chickpea, succulent shelled...................................      0.05

                                * * * * *
Cowpea, dry seed..............................................       0.3
Cowpea, edible podded.........................................       0.7
Cowpea, forage................................................        15
Cowpea, hay...................................................        80
Cowpea, succulent shelled.....................................       0.7

                                * * * * *
Jackbean, dry seed............................................       0.3
Jackbean, edible podded.......................................       0.7
Jackbean, succulent shelled...................................       0.7

                                * * * * *
Lentil, dry seed..............................................       0.1
Lentil, edible podded.........................................         2
Lentil, succulent shelled.....................................      0.05
Longbean, Chinese, dry seed...................................       0.3
Longbean, Chinese, edible podded..............................       0.7
Lupin, Andean, dry seed.......................................       0.3
Lupin, Andean, succulent shelled..............................       0.7
Lupin, blue, dry seed.........................................       0.3
Lupin, blue, succulent shelled................................       0.7
Lupin, grain, dry seed........................................       0.3
Lupin, grain, succulent shelled...............................       0.7
Lupin, sweet, dry seed........................................       0.3
Lupin, sweet, succulent shelled...............................       0.7
Lupin, white sweet, dry seed..................................       0.3
Lupin, white sweet, succulent shelled.........................       0.7
Lupin, white, dry seed........................................       0.3
Lupin, white, succulent shelled...............................       0.7
Lupin, yellow, dry seed.......................................       0.3
Lupin, yellow, succulent shelled..............................       0.7

                                * * * * *
Pea, blackeyed, dry seed......................................       0.3
Pea, blackeyed, succulent shelled.............................       0.7
Pea, crowder, dry seed........................................       0.3
Pea, crowder, succulent shelled...............................       0.7
Pea, dry, dry seed............................................       0.1
Pea, dwarf, edible podded.....................................         2
Pea, English, succulent shelled...............................      0.05
Pea, field, dry seed..........................................       0.1
Pea, field, forage............................................        15
Pea, field, hay...............................................        80
Pea, garden, dry seed.........................................       0.1
Pea, garden, succulent shelled................................      0.05
Pea, grass, dry seed..........................................       0.1
Pea, grass, edible podded.....................................         2
Pea, green, dry seed..........................................       0.1
Pea, green, edible podded.....................................         2
Pea, green, succulent shelled.................................      0.05
Pea, pigeon, dry seed.........................................       0.1
Pea, pigeon, edible podded....................................         2
Pea, pigeon, succulent shelled................................      0.05
Pea, snap, edible podded......................................         2
Pea, snow, edible podded......................................         2
Pea, southern, dry seed.......................................       0.3
Pea, southern, succulent shelled..............................       0.7
Pea, sugar snap, edible podded................................         2
Pea, winged, dry seed.........................................       0.3
Pea, winged, edible podded....................................       0.7

                                * * * * *
Soybean, vegetable, dry seed..................................       0.3
Soybean, vegetable, edible podded.............................       0.7
Soybean, vegetable, succulent shelled.........................       0.7

                                * * * * *
Velvetbean, dry seed..........................................       0.3
Velvetbean, edible podded.....................................       0.7
Velvetbean, succulent shelled.................................       0.7
------------------------------------------------------------------------

* * * * *
[FR Doc. 2022-20332 Filed 9-20-22; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 83, Number 122 (Monday, June 25, 2018)]
[Notices]
[Page 29564]
[FR Doc No: 2018-13522]

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

DEPARTMENT OF HOMELAND SECURITY

Coast Guard

[Docket No. USCG-2018-0136]

Information Collection Request to Office of Management and
Budget; OMB Control Number: 1625--NEW

AGENCY: Coast Guard, DHS.

ACTION: Sixty-day notice requesting comments.

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

SUMMARY: In compliance with the Paperwork Reduction Act of 1995, the
U.S. Coast Guard intends to submit an Information Collection Request
(ICR) to the Office of Management and Budget (OMB), Office of
Information and Regulatory Affairs (OIRA), requesting approval for the
following collection of information: 1625--NEW, Coast Guard Art Program
Membership Application Form. Our ICR describes the information we seek
to collect from the public. Before submitting this ICR to OIRA, the
Coast Guard is inviting comments as described below.

DATES: Comments must reach the Coast Guard on or before August 24,
2018.

ADDRESSES: You may submit comments identified by Coast Guard docket
number [USCG-2018-0136] to the Coast Guard using the Federal
eRulemaking Portal at http://www.regulations.gov. See the ``Public
participation and request for comments'' portion of the SUPPLEMENTARY
INFORMATION section for further instructions on submitting comments.
    A copy of the ICR is available through the docket on the internet
at http://www.regulations.gov. Additionally, copies are available from:
Commandant (CG-612), Attn: Paperwork Reduction Act Manager, U.S. Coast
Guard, 2703 Martin Luther King Jr. Ave. SE, STOP 7710, Washington, DC
20593-7710.

FOR FURTHER INFORMATION CONTACT: Mr. Anthony Smith, Office of
Information Management, telephone<PHONE_NUMBER>, or fax<PHONE_NUMBER>,
for questions on these documents.

SUPPLEMENTARY INFORMATION:

Public Participation and Request for Comments

    This Notice relies on the authority of the Paperwork Reduction Act
of 1995; 44 U.S.C. Chapter 35, as amended. An ICR is an application to
OIRA seeking the approval, extension, or renewal of a Coast Guard
collection of information (Collection). The ICR contains information
describing the Collection's purpose, the Collection's likely burden on
the affected public, an explanation of the necessity of the Collection,
and other important information describing the Collection. There is one
ICR for each Collection.
    The Coast Guard invites comments on whether this ICR should be
granted based on the Collection being necessary for the proper
performance of Departmental functions. In particular, the Coast Guard
would appreciate comments addressing: (1) The practical utility of the
Collection; (2) the accuracy of the estimated burden of the Collection;
(3) ways to enhance the quality, utility, and clarity of information
subject to the Collection; and (4) ways to minimize the burden of the
Collection on respondents, including the use of automated collection
techniques or other forms of information technology. In response to
your comments, we may revise this ICR or decide not to seek approval
for the Collection. We will consider all comments and material received
during the comment period.
    We encourage you to respond to this request by submitting comments
and related materials. Comments must contain the OMB Control Number of
the ICR and the docket number of this request, [USCG-2018-0136], and
must be received by August 24, 2018.

Submitting Comments

    We encourage you to submit comments through the Federal eRulemaking
Portal at http://www.regulations.gov. If your material cannot be
submitted using http://www.regulations.gov, contact the person in the
FOR FURTHER INFORMATION CONTACT section of this document for alternate
instructions. Documents mentioned in this notice, and all public
comments, are in our online docket at http://www.regulations.gov and
can be viewed by following that website's instructions. Additionally,
if you go to the online docket and sign up for email alerts, you will
be notified when comments are posted.
    We accept anonymous comments. All comments received will be posted
without change to http://www.regulations.gov and will include any
personal information you have provided. For more about privacy and the
docket, you may review a Privacy Act notice regarding the Federal
Docket Management System in the March 24, 2005, issue of the Federal
Register (70 FR 15086).

Information Collection Request

    Title: Coast Guard Art Program Membership Application Form.
    OMB Control Number: 1625--NEW.
    Summary: This collection of information contains the application
form for membership and samples of artwork for those wishing to become
Coast Guard Art Program (COGAP) member artists.
    Need: The application and samples of artwork are needed to
determine if the applicant has the necessary artistic skills and
ability to become a contributing member of the COGAP. The authority to
collect this information is contained in 5 U.S.C. 301, Departmental
regulations; 14 U.S.C. 93(a)(6), Commandant general powers; and 44
U.S.C. 3101, Records management by agency heads.
    Forms: CG-5700, Membership Application Form.
    Respondents: Artist interested in becoming contributing member of
the Coast Guard Art Program.
    Frequency: Annually.
    Hour Burden Estimate: This is a new collection. The estimated
burden is 10 hours a year.

    Authority: The Paperwork Reduction Act of 1995; 44 U.S.C.
Chapter 35, as amended.

    Dated: June 19, 2018.
James D. Roppel,
Acting Chief, U.S. Coast Guard, Office of Information Management.
[FR Doc. 2018-13522 Filed 6-22-18; 8:45 am]
 BILLING CODE 9110-04-P


[Federal Register Volume 77, Number 16 (Wednesday, January 25, 2012)]
[Notices]
[Page 3760]
[FR Doc No: 2012-1420]

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

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Notice Announcing Filing Priority for Preliminary Permit
Applications

------------------------------------------------------------------------
                                                                Project
                                                                  No.
------------------------------------------------------------------------
FFP Project 17, LLC.........................................   12865-002
Northland Power Mississippi River LLC.......................   14072-000
------------------------------------------------------------------------

    On January 17, 2012, the Commission held a drawing to determine
priority among competing preliminary permit applications with identical
filing times. In the event that the Commission concludes that none of
the applicants' plans are better adapted than the others to develop,
conserve, and utilize in the public interest the water resources of the
region at issue, the priority established by this drawing will serve as
the tiebreaker. Based on the drawing, the order of priority is as
follows:
    1. Northland Power Mississippi River LLC; Project No. 14072-000.
    2. FFP Project 17, LLC; Project No. 12865-002.

    Dated: January 18, 2012.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2012-1420 Filed 1-24-12; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register: June 15, 2010 (Volume 75, Number 114)]
[Notices]
[Page 33869-33871]
[DOCID:fr15jn10-126]

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

SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-62234; File No. SR-Phlx-2010-78]

Self-Regulatory Organizations; NASDAQ OMX PHLX, Inc.; Notice of
Filing and Immediate Effectiveness of Proposed Rule Change Relating to
Trading Halts in Foreign Currency Options Under Rule 133

June 7, 2010.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(the ``Act'') \1\ and Rule 19b-4 thereunder,\2\ notice is hereby given
that, on June 1, 2010, NASDAQ OMX PHLX, Inc. (``Phlx'' or the
``Exchange'') filed with the Securities and Exchange Commission (the
``Commission'') the proposed rule change as described in Items I and II
below, which Items have been prepared by the Exchange. The Commission
is publishing this notice to solicit comments on the proposed rule
change from interested persons.
---------------------------------------------------------------------------

    \1\ 15 U.S.C.78s(b)(1).
    \2\ 17 CFR 240.19b-4.
---------------------------------------------------------------------------

I. Self-Regulatory Organization's Statement of the Terms of Substance
of the Proposed Rule Change

    The Exchange proposes to amend Rule 133, Trading Halts Due to
Extraordinary Market Volatility, to delete a parenthetical exception
for trading in foreign currency options. The text of the proposed rule
change is available on the Exchange's Web site at http://
www.nasdaqtrader.com/micro.aspx?id=PHLXRulefilings, at the principal
office of the Exchange, and at the Commission's Public Reference Room.

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

    In its filing with the Commission, the Exchange 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 those statements may be examined at the places specified in
Item IV below. The Exchange has prepared summaries, set forth in
sections A, B, and C below, of the most significant parts of such
statements.

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

1. Purpose
    Currently, Rule 133 provides that trading in securities (other than
FCOs) shall halt on the Exchange and shall not reopen for the time
periods described in the rule if the Dow Jones Industrial Average
reaches certain levels below its closing value on the previous trading
day. When the Exchange added the parenthetical exceptions regarding
FCOs to Rule 133 in 1997, all FCOs trading on the Exchange were
physically settled options that traded on a different system than the
system on which equity and index options traded.\3\ The Exchange has
since delisted all physical delivery FCOs.
---------------------------------------------------------------------------

    \3\ It was therefore a straightforward and simple process to
halt trading in equity and index options without also being required
to halt the FCOs that traded on a separate system. Due to an
oversight, the text of Rule 133 was not also amended when U.S.
dollar-settled FCOs were originally listed to make clear that U.S.
dollar-settled FCOs, unlike physical delivery FCOs, would indeed
halt if the circuit breaker provisions were triggered and equity and
index options trading were halted.
---------------------------------------------------------------------------

    In 2006 the Exchange began listing and trading U.S. dollar-settled
FCOs.\4\ Unlike the physical delivery FCOs which the Exchange also
listed at the time, the U.S. dollar-settled FCOs trade on the same
platform as the Exchange's equity and equity index options.
Consequently, due to trading system limitations when U.S. dollar-
settled FCOs were first listed by the Exchange, it was not feasible to
halt trading in equity and equity index options without also halting
trading in U.S. dollar-settled FCOs. The proposing release for the U.S.
dollar-settled FCOs therefore stated that ``[i]n the event of system-
wide trading halts in equity and equity index options required by
Exchange Rule 133 (the `circuit breaker' rule), Trading Halts Due to
Extraordinary Market Volatility, trading in U.S. dollar-settled FCO
also would be halted.'' \5\ The Exchange is now updating Rule 133 to
reflect that, consistent with the Exchange's proposed rule change to
list and trade the U.S. dollar-settled FCOs, trading U.S. dollar-
settled FCOs is also halted in the event equity and index options
trading is halted pursuant to Rule 133.
---------------------------------------------------------------------------

    \4\ See Securities Exchange Act Release No. 54989 (December 21,
2006), 71 FR 78506 (December 29, 2006) (approving SR-Phlx-2006-34).
    \5\ See Securities Exchange Act Release No. 54652 (October 25,
2006), 71 FR 64597 (November 2, 2006), footnote 33.
---------------------------------------------------------------------------

2. Statutory Basis
    The Exchange believes that its proposal is consistent with Section
6(b) of the Act \6\ in general, and furthers the objectives of Section
6(b)(5) of the Act \7\ in particular, in that it is designed to promote
just and equitable principles of trade, to remove impediments to and
perfect the mechanism of a free and open market and a national market
system, and, in general to protect investors and the public interest,
by clarifying in Exchange Rule 133 that trading in U.S. dollar-settled
FCO also halts when trading in equity and equity index options halts
pursuant to that rule.
---------------------------------------------------------------------------

    \6\ 15 U.S.C. 78f(b).
    \7\ 15 U.S.C. 78f(b)(5).
---------------------------------------------------------------------------

B. Self-Regulatory Organization's Statement on Burden on Competition

    The Exchange does not believe that the proposed rule change will
impose any burden on competition 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

    No written comments were either solicited or received.

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

    Because the foregoing proposed rule change: (i) Does not
significantly affect the protection of investors or the public
interest; (ii) does not impose any significant burden on competition;
and (iii) by its terms, does not become operative for 30 days from the
date on which it was filed, or such shorter time as the Commission may
designate, if consistent with the protection of investors and the
public interest, it has become effective pursuant to Section
19(b)(3)(A) of the Act \8\ and Rule 19b-4(f)(6) thereunder.\9\
---------------------------------------------------------------------------

    \8\ 15 U.S.C. 78s(b)(3)(A).
    \9\ 17 CFR 240.19b-4(f)(6). In addition, Rule 19b-4(f)(6)(iii)
requires the self-regulatory organization to submit to the
Commission written notice of its intent to file the proposed rule
change, along with a brief description and text of the proposed rule
change, at least five business days prior to the date of filing of
the proposed rule change, or such shorter time as designated by the
Commission. The Exchange has satisfied this requirement.
---------------------------------------------------------------------------

    A proposed rule change filed pursuant to Rule 19b-4(f)(6) under the
Act \10\ normally does not become operative for 30 days after the date
of its filing. However, Rule 19b-4(f)(6)(iii) \11\ permits the
Commission to designate a shorter time if such action is consistent
with the protection of investors and the public interest. The Exchange
has requested that the Commission waive the 30-day operative delay.
---------------------------------------------------------------------------

    \10\ 17 CFR 240.19b 4(f)(6).
    \11\ 17 CFR 240.19b 4(f)(6)(iii).
---------------------------------------------------------------------------

    The Commission believes that waiver of the operative delay is
consistent with the protection of investors and the public interest
because the proposed rule change would immediately conform Phlx Rule
133 to the Exchange's practice since 2006. As noted above, when the
Exchange began listing and trading U.S. dollar-settled FCOs in 2006, it
stated in its notice of the proposed rule change that the trading halts
in Rule 133 would apply to U.S. dollar-settled FCOs.\12\ However, at
that time, the Exchange did not amend Rule 133 to make clear that U.S.
dollar-settled FCOs, unlike physical delivery FCOs, would halt if the
circuit breaker provisions were triggered. As such, the Commission
believes that the current proposed rule change raises no new regulatory
issues and waiver of the operative delay will allow the Exchange to
immediately clarify in its rules its current practice with regard to
trading halts and FCOs. For these reasons, the Commission designates
the proposal operative upon filing.\13\
---------------------------------------------------------------------------

    \12\ See supa note 5 and accompanying text.
    \13\ For purposes only of waiving the operative delay for this
proposal, the Commission has considered the proposed rule's impact
on efficiency, competition, and capital formation. See 15 U.S.C.
78c(f).
---------------------------------------------------------------------------

    At any time within 60 days of the filing of the proposed rule
change, the Commission may summarily abrogate such 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 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-Phlx-2010-78 on the subject line.

Paper Comments

     Send paper comments in triplicate to Elizabeth M. Murphy,
Secretary,

Securities and Exchange Commission, 100 F Street, NE., Washington, DC
20549-1090.

All submissions should refer to File Number SR-Phlx-2010-78. 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 Web site viewing and
printing in the Commission's Public Reference Room, 100 F Street, NE.,
Washington, DC 20549, on official business days between the hours of 10
a.m. and 3 p.m. Copies of such filing also will be available for
inspection and copying at the principal office of the Exchange. 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-Phlx-2010-78 and should be
submitted on or before July 6, 2010.
---------------------------------------------------------------------------

    \14\ 17 CFR 200.30-3(a)(12).

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\14\
Florence E. Harmon,
Deputy Secretary.
[FR Doc. 2010-14362 Filed 6-14-10; 8:45 am]
BILLING CODE 8011-01-P


PAPERWORK REDUCTION ACT SUBMISSION Please read the instructions before completing this form. For additional forms or assistance in completing this form, contact your agency's Paperwork Clearance Officer. Send two copies of this form, the collection instrument to be reviewed, the Supporting Statement and any additional documentation to: Office of Information and Regulatory Affairs, Office of Management and Budget, Docket Library, Room 10102, 725 17th Street NW Washington, DC 20503.

1. Agency/ Subagency originating request USEPA/ Office of Enforcement and Compliance Assurance 2. OMB control number b. G None a. 2 0 6 0  0 0 7 2 __ __ __ __ __

3. Type of information collection ( check one) a. G New collection b. G Revision of a currently approved collection c. X Extension of a currently approved collection d. G Reinstatement, without change, of a previously approved collection for which approval has expired e. G Reinstatement, with change, of a previously approved collection for which approval has expired f. G Existing collection in use without an OMB control number 4. Type of review requested ( check one) a. X Regular b. G Emergency  Approval requested by: / / c. G Delegated 5. Small entities Will this information collection have a significant economic impact on a substantial number of small entities? G Yes X No For b f, note item A2 of Supporting Statement Instructions 6. Requested expiration date a. X Three years from approval date b. G Other Specify: / /___

7. Title NSPS for Industrial Commercial Institutional Steam Generating Units, ( 40 CFR part 60, subpart Db)

8. Agency form number( s) ( If applicable) EPA ICR No. 1088.10 9. Keywords Steam generating units; information collection; standards of performance 10. Abstract Owners or operators of affected facilities must: make one time only notifications of occurrences such as construction/ reconstruction and startup; submit reports containing information such as monitoring results and excess emissions; and maintain records of occurrences such as startups and shutdowns. Responses to this information collection are deemed to be mandatory, per Section 114( a) of the Clean Air Act.

11. Affected public ( Mark primary with " P" and all others that apply with " X") a. Individuals or households d. Farms b. P Business or other for profit e. Federal Government c. Not for profit institutions f. State, Local or Tribal Government 12. Obligation to respond ( Mark primary with " P" and all others that apply with " X") a. G Voluntary b. G Required to obtain or retain benefits c. P Mandatory 13. Annual reporting and recordkeeping hour burden a. Number of respondents 1,230 b. Total annual responses 2,952 1. Percentage of these responses collected electronically 20 % c. Total hours requested 591,389 d. Current OMB inventory 575,033 e. Difference 16,356 f. Explanation of difference 1. Program Change 0 2. Adjustment 16,356 14. Annual reporting and recordkeeping cost burden ( in thousands of dollars)

a. Total annualized capital/ startup costs 9,000 b. Total annual costs ( O& M) 17,775 c. Total annualized cost requested 26,775 d. Current OMB inventory 25,955 e. Difference 820 f. Explanation of difference 1. Program change 0 2. Adjustment 820 15. Purpose of information collection ( Mark Primary With " P" and all others that apply with " X") a. Application for benefits e. Program planning or management b. Program evaluation f. Research c. General purpose statistics g. P Regulatory or compliance d. __ Audit 16. Frequency of recordkeeping or reporting ( check all that apply) a. X Recordkeeping b. Q Third party disclosure c. X Reporting 1. Q On occasion 2. Q Weekly 3. Q Monthly 4. X Quarterly 5. X Semi annually 6. Q Annually 7. Q Biannually 8. Q Other ( describe)

17. Statistical methods Does this information collection employ statistical methods?

Q Yes X No 18. Agency contact ( person who can best answer questions regarding the content of this submission) Name: Dan Chadwick Phone: ( 202)  564  7054 OMB 83 I 10/ 95 19. Certification for Paperwork Reduction Act Submissions On behalf of this Federal agency, I certify that the collection of information encompassed by this request complies with' 5 CFR 1320.9.

NOTE: The text of 5 CFR 1320.9, and the related provisions of 5 CFR 1320.8( b)( 3), appear at the end of the instructions. The certification is to be made with reference to those regulatory provisions as set forth in the instructions.

The following is a summary of the topics, regarding the proposed collection of information, that the certification covers:

( a) It is necessary for the proper performance of agency functions;

( b) It avoids unnecessary duplication;

( c) It reduces burden on small entities;

( d) It uses plain, coherent, and unambiguous terminology that is understandable to respondents;

( e) Its implementation will be consistent and compatible with current reporting and recordkeeping practices;

( f) It indicates the retention periods for recordkeeping requirements;

( g) It informs respondents of the information called for under 5 CFR 1320.8( b)( 3):

( i) Why the information is being collected; ( ii) Use of information; ( iii) Burden estimate; ( iv) Nature of response ( voluntary, required for a benefit, or mandatory); ( v) Nature and extent of confidentiality; and ( vi) Need to display currently valid OMB control number;

( h) It was developed by an office that has planned and allocated resources for the efficient and effective management and use of the information to be collected ( see note in Item 19 of the instructions);

( i) It uses effective and efficient statistical survey methodology; and ( j) It makes appropriate use of information technology.

If you are unable to certify compliance with any of these provisions, identify the item below and explain the reason in Item 18 of the Supporting Statement.

Signature of Program Official Michael S. Alushin, Director Compliance Assessment and Media Programs Division Office of Compliance Office of Enforcement and Compliance Assurance Date Signature of Senior Official or designee Oscar Morales, Director Collection Strategies Division Office of Environmental Information Date OMB 83 I 10/ 95 Certification Requirement for Paperwork Reduction Act Submissions 5 CFR 1320.9 reads " As part of the agency submission to OMB of a proposed collection of information, the agency ( through the head of the agency, the Senior Official or their designee) shall certify ( and provide a record supporting such certification) that the proposed collection of information

"( a) is necessary for the proper performance of the functions of the agency, including that the information to be collected will have practical utility;

"( b) is not unnecessarily duplicative of information otherwise reasonably accessible to the agency;

"( c) reduces to the extent practicable and appropriate the burden on persons who shall provide information to or for the agency, including with respect to small entities, as defined in the Regulatory Flexibility Act 5 U. S. C. § 601( 6)), the use of such techniques as:

"( 1) establishing differing compliance or reporting requirements or timetables that take into account the resources available to those who are to respond; "( 2) the clarification, consolidation, or simplification of compliance and reporting requirements; or collection of information , or any part thereof; "( 3) an exemption from coverage of the collection of information, or any part thereof;

"( d) is written using plain, coherent, and unambiguous terminology and is understandable to those who are to respond;

"( e) is to be implemented in ways consistent and compatible, to the maximum extent practicable, with the existing reporting and recordkeeping practices of those who are to respond;

"( f) indicates for each recordkeeping requirement the length of time persons are required to maintain the records specified;

"( g) informs potential respondents of the information called for under § 1320.8( b)( 3); [ see below]

"( h) has been developed by an office that has planned and allocated resources for the efficient and effective management and use of the information to be collected, including the processing of the information in a manner which shall enhance, where appropriate, the utility of the information to agencies and the public;

"( i) uses effective and efficient statistical survey methodology appropriate to the purpose for which the information is to be collected; and "( j) to the maximum extent practicable, uses appropriate information technology to reduce burden and improve data quality, agency efficiency and responsiveness to the public."

NOTE: 5 CFR 1320.8( b)( 3) requires that each collection of information:

"( 3) informs and provides reasonable notice to the potential persons to whom the collection of information is addressed of:

"( i) the reasons the information is planned to be and/ or has been used to further the proper performance of the functions of the agency; "( ii) the way such information is planned to be and/ or has been used to further the proper performance of the functions of the agency; "( iii) an estimate, to the extent practicable, of the average burden of the collection ( together with a request that the public direct to the agency any comments concerning the accuracy of this burden estimate and any suggestions for reducing this burden); "( iv) whether responses to the collection of information are voluntary, required to obtain or retain a benefit ( citing authority), or mandatory ( citing authority); "( v) the nature and extent of confidentiality to be provided, if any ( citing authority); and "( vi) the fact that any agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number."

OMB 83 I ( Instructions) 10/ 95


	UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

WASHINGTON, D.C.  20460

OFFICE OF

PREVENTION, PESTICIDES

AND TOXIC SUBSTANCES

Date: March 27, 2008

MEMORANDUM

SUBJECT:	Formaldehyde/paraformadehyde  - Report of the Antimicrobials
Division Toxicity Endpoint Selection Committee (ADTC).

FROM:	Timothy F. McMahon, Ph.D., Chair, ADTC

Antimicrobials  Division (7510C)

TO:		Sharon Carlisle, Chemical Review Manager

		Mark Hartman, Branch Chief

		Regulatory Management Branch II

		Antimicrobials Division (7510C)

		         And

		Timothy F. McMahon, Ph.D., Risk Assessor

		Antimicrobials Division  (7510C)

 		PC Code:  043001; 043002

On  January 29, 2008,  the Antimicrobials Division's Toxicity Endpoint
Selection Committee (ADTC)  evaluated the toxicology data base of
formaldehyde,  and selected  toxicological endpoints appropriate for the
currently registered uses of formaldehyde and paraformaldehyde. The
conclusions of this meeting are presented in this report.

Committee Members in Attendance

Members present were:  John Redden;  Stephen Dapson, Ph.D.;  Jonathan
Chen, Ph.D., Michelle Centra, Najm Shamim, Ph.D; Timothy F. McMahon,
Ph.D.; Roger Gardner; Jenny Tao.

I. INTRODUCTION

Formaldehyde  is used primarily as a fumigant in agricultural premises
such as poultry and swine farms and processing plants as well as in
citrus and mushroom houses.  It is used as a hard surface disinfectant
in commercial premises, industrial premises and veterinary clinics.
Formaldehyde containing products are also used in oil drilling wells for
preservation of processing waters. There are no dietary uses of
formaldehyde.

™Fumigant is used as a bacteriostat, fungicide, and sanitizer in
hair/beauty salons and barber shops, and Sun Pac is used as mildewcide
for closets, cupboards, dresser drawers, trunks, suitcases, lockers,
golf bags, trailers, bathroom and kitchens, and mobile homes.

II.	HAZARD IDENTIFICATION

A1. Acute Reference Dose (aRfD) [general population including infants
and children]

There are no expected dietary exposures to formaldehyde or
paraformaldehyde from the currently registered uses.  Therefore an
acute reference dose value is not needed.

A2. Acute Reference Dose (females 13-49)

 There are no expected dietary exposures to formaldehyde or
paraformaldehyde from the currently registered uses.  Therefore an
acute reference dose value is not needed.

 	B. Chronic Reference Dose (cPAD)

There are no expected dietary exposures to formaldehyde or
paraformaldehyde from the currently registered uses.  Therefore a
chronic reference dose value is not needed.  There is an existing
chronic reference dose value in the current EPA IRIS assessment for
formaldehyde, but for registered antimicrobial uses this value is not
needed.

C. Incidental Oral Exposure

 The committee determined that an incidental oral endpoint was not
needed for formaldehyde. Formaldehyde is  highly volatile with a low
percentage of active ingredient in those products with residential
exposures (laundry detergents, general household cleaners) and residues
available for incidental oral exposure are not expected to occur.  An
accidental ingestion is considered a misuse and is not a regulatory
endpoint. Therefore, no incidental oral endpoint was selected.

D. Dermal Exposure

There are available studies on the dermal irritancy and dermal
sensitization potential of formaldehyde (Krivanek et al., Flyvholm et
al, 1997). These data demonstrate irritancy and sensitization potential
of formaldehyde, which is well known. However, the committee determined
that dermal endpoints are not needed for formaldehyde for the registered
antimicrobial uses. Residential uses do not involve purposeful contact
with the skin.  Use in laundry detergents and household cleaners is not
expected to result in any significant dermal exposure based on the high
water solubility of formaldehyde and the volatility of the active
ingredient.

E. Inhalation Exposure (all durations)

The committee considered the data set forth in the 2001 ACGIH
publication on formaldehyde as relevant for selection of a non-cancer
inhalation endpoint for use in risk assessment. Inhalation is the major
route of exposure to formaldehyde and thus hazard and risk need to be
addressed from inhalation exposures.

As noted in the ACGIH document, “A TLV-Ceiling of 0.3 ppm (0.37 mg/m3)
is recommended for occupational exposure to formaldehyde. This value is
recommended to minimize the potential for sensory irritation, chiefly
eye and upper respiratory tract. Although the recommended TLV is
intended to protect nearly all workers, ACGIH recognizes that the value
may not safeguard that portion of the worker population (10-20%)
reported to be responsive to low ambient concentrations (< 0.25 ppm), of
the chemical…”

Additional published literature on human exposure to formaldehyde via
inhalation (Ballarin, C. at al., Mutat. Res. 280(1), 1992;
Akbar-Khanzadeh F., Am. J. Ind. Med. 26(1), 1994; Dally, KA et al.,
Arch. Environ. Health 36(6), 1981; Alexandersson and Hedenstierna, Arch.
Environ. Health 43(3), 1988; 	Alexandersson and Hedenstierna, Arch.
Environ. Health 44(1), 1989) show effects of formaldehyde on pulmonary
function and irritation of the eye and nasal passages at similar
concentrations.  The level of formaldehyde causing such symptoms does
not appear to vary regardless of exposure duration (i.e. hours to
years).

In 2005, the Registration Division, in conjunction with the
Antimicrobials Division, issued an emergency exemption for use of
paraformaldehyde to decontaminate microbiological containment areas and
equipment. In this assessment, the NOAEL of 0.1 ppm was selected  from
the epidemiology study of Horvath et al. (JAMA 259(5), 1988), who
recorded complaints of eye, nose, and throat irritation in particle
board workers at concentrations of formaldehyde from 0.4 – 1.0 ppm.
Four additional studies were cited in the 2005 assessment as co-critical
in support of the selected NOAEL value.

For occupational exposures, the committee felt that the 0.1 ppm
inhalation endpoint was appropriate. No uncertainty factor was applied
for occupational assessments.  However, for residential and children’s
inhalation exposure, an uncertainty factor of 10x was applied to the 01
ppm endpoint.  The common effects of formaldehyde exposure are various
symptoms as a result of irritation of the mucosa in the eyes and upper
airways. In the non-industrial indoor environment, sensory reactions are
typical effects, but there are large individual differences in the
normal population and between hyperreactive and sensitized people.
Thus, the committee concluded that in order to protect sensitive
subpopulations (children, older people and/or sensitized persons), an
extra safety factor of 10X is applied to address this concern.

F. Recommendation for Aggregate Risk Assessments

 Inhalation exposures are appropriate for aggregate risk assessment.

CLASSIFICATION OF CARCINOGENIC POTENTIAL

Formaldehyde has been extensively investigated for carcinogenic
potential and several regulatory organizations including the government
of Australia and IARC have reviewed the available carcinogenicity data
in animals and humans with respect to formaldehyde.  A detailed review
is not necessary here but links to the documentation are:   HYPERLINK
"http://www.nicnas.gov.au"  www.nicnas.gov.au  for the Australian
review, and   HYPERLINK "http://monographs.iarc.fr/"
http://monographs.iarc.fr/  for the IARC publication.  The U.S. EPA
National Center for Environmental Assessment (NCEA) is also in the
process of updating the carcinogenic assessment for formaldehyde.
Information from the draft document is reproduced here with permission.

The Agency is currently reevaluating the carcinogenic potential of
formaldehyde. The historical and ongoing development of an inhalation
unit risk value to assess the carcinogenic potential of formaldehyde is
briefly summarized below. Contributors to this summary included
scientists from several EPA program offices (OPP, OPPT, ORD, OAR, and
NHEERL)

e human carcinogen with a potency factor of 1.3 E-5 per (μg/m3) ) on
the basis of squamous cell nasal tumors observed in a two-year study in
rats (Kerns et al., 1983).

In 1999 the Chemical Industry Institute of Toxicology (CIIT) developed a
health risk assessment for formaldehyde based upon the animal toxicology
data (CIIT, 1999).  This document presented the dose-response modeling
of these data in two distinct parts: 1). based upon a biologically-based
dose response (BBDR) model , 2) benchmark dose models that were based
upon point of departures at various response levels of the tumor and
precursor data.  Both these approaches made extensive use of the
available time-to-tumor and mechanistic information. The 1999 assessment
was subsequently published in various articles in peer-reviewed journals
(2001, 2002, 2003, 2004).

In 1999, the U.S. EPA’s Office of Air and Radiation and Office of
Research and Development, in conjunction with Health Canada, conducted
an external peer review workshop for the CIIT BDDR model as well as an
external written peer review and public comment period for their
assessments. While the review was largely positive on the overall
approach in the assessment, reviewers also pointed to the potential for
significant uncertainty due to model mis-specification and uncertainties
in key parameters involved in the BBDR model

Based on the peer review of the CIIT model, OAR determined in 2004 that
the CIIT model was the most appropriate tool for risk assessment for
formaldehyde.   OAR has subsequently used the formaldehyde cancer
potency derived using the CIIT model for a number of risk assessments
involving formaldehyde emissions to the atmosphere such as the Plywood
and Composite Wood Products National Emission Standard for Hazardous Air
Pollutants (final rule 2004, reconsidered final rule 2006, remanded to
EPA by court 2007); Control of Hazardous Air Pollutants from Mobile
Sources (Final Rule 2007); and Proposed Rule for National Emission
Standard for Combustion Turbines (2004). Health Canada, Australia, the
World Health Organization, and the German MAK Commission have also used
the CIIT model. Model strengths include consideration of the mode of
action data for formaldehyde and a conservative approach to account for
potential direct DNA interaction and mutation induction.  Model
uncertainties include variability for some of the parameters of the
model (e.g., cell proliferation) which can affect predictions of risk
(Subramanian et al 2007;   2008 [in press]).

In 2004, NCEA convened a panel of experts, including scientists from
CIIT, to provide advice on these and other critical biological and
statistical uncertainties.  The strength of the CIIT model is its
consideration of mode of action and extensive mechanistic information.

Although current OAR assessments still use the CIIT model, these
assessments now acknowledge previously unknown uncertainties with the
CIIT model when characterizing the risk results.

In 2004, the International Agency for Research on Cancer (IARC)
characterized formaldehyde as a human carcinogen based on their review
of the current literature (IARC, 2004), including data in humans on
nasopharyngeal cancer,  cancer of the nasal cavity and paranasal
sinuses,and  leukemia.  It should be noted that some epidemiology
studies did not find a reported association between formaldehyde
exposure and carcinogenicity. For example, Coggon et al, 2003 studied
over 14,000 workers exposed to formaldehyde in industrial workplaces and
reported no excesses of either leukemia or nasal and nasopharyngeal
cancer.

In 2005, the Scientific Review Panel (SRP) of the California Office of
Environmental Health Hazard Assessment responded to the CA Air Resources
Board request to reevaluate the carcinogenic potential of formaldehyde.
The Panel noted in this 2005 review that OEHHA’s November 2002
evaluation of a petition had included the 1999 report on the CIIT model
and other information, and that California’s OEHHA had concluded that
“the evidence…(1) did not change the determination that formaldehyde
is a carcinogen; (2) presented information that considered the
possibility of non-linear dose response relationships, but presented no
clear grounds to review the original “no threshold” determination;
and (3) did not provide any new epidemiology or bioassays supporting a
change in potency.   In addition, there was insufficient information to
fully evaluate the CIIT model, issues such as model uncertainty were not
adequately addressed….”   The Scientific Review Panel’s overall
conclusion in 2005 was,  “The Panel concluded that there was not
sufficient new data to support the petition to review the [OEHHA’s
earlier 1992] formaldehyde risk assessment.  In addition, the newly
published studies represented relevant new information, but they did not
allow determination of a causal relationship between formaldehyde
exposure and leukemia.  These studies deserve further evaluation over
time given their potential importance.”  Froines (2005).

EPA is currently completing a new IRIS assessment and unit risk value
for formaldehyde; the reassessment is scheduled to start internal peer
review in May 2008 and begin independent external peer review in January
2009
(http://cfpub.epa.gov/ncea/iristrac/index.cfm?fuseaction=viewChemical.sh
owChemical&sw_id=1031).  EPA anticipates that the peer review of the
formaldehyde assessment will be a longer process then that of EPA’s
reregistration process scheduled to conclude in September 2008.

Based of the on going development of the science to predict carcinogenic
potential of formaldehyde, OPP has decided to present the formaldehyde
cancer risks for the pesticidal uses using both the existing 1991 IRIS
cancer unit risk of 1.3 E-5 per (µg/m3) and the CIIT BBDR model until
any new cancer estimates are fully peer reviewed.  OPP also acknowledges
the wide range in cancer risks using these approaches and will
coordinate with other offices in EPA on the outcome of the upcoming peer
review process on the carcinogenicity of formaldehyde.  Because
formaldehyde air concentrations approach those associated with ocular
and respiratory tract irritation, the risk mitigation measures to be
implemented in the meantime for the pesticidal uses will be based on
mitigating the non-cancer effects at a limit of 0.01 ppm.  It is
believed that this level will reduce exposures sufficiently such that
the cancer risks would not be of concern.  The EPA  process of
regulating pesticides allows for reevaluation at any time if new
information from the peer review process of the carcinogenic potential
of formaldehyde warrants.

MUTAGENICITY

 Formaldehyde’s mutagenicity has been examined in a variety of in
vitro and in vivo test systems. In a bacterial reverse mutation test
(MRID 00132156), formaldehyde (2%) was tested at concentrations of
0.001, 0.01, 0.10, 1.0, or 5.0 µL and found to be negative. In a second
submitted study (MRID 00132157), formaldehyde (2%) was tested at
concentrations of 3.0, 15.0, 75.0, 150, or 300 µg/plate and found to be
positive in the bacterial reverse mutation assay. Formaldehyde caused a
positive response (3.2-fold increase) on tester strain TA98 without
metabolic activation. A 1.9-fold increase was observed on TA98 with
metabolic activation. Also, increases of 2.2-fold and 1.7-fold were
observed on tester strain TA100 with and without activation,
respectively. In an in vitro mammalian chromosome aberration test (MRID
00132168), formaldehyde (37% formalin), was tested on Chinese hamster
ovary cells at concentrations of 28.43, 37.91, or 50.55 nL/mL. The test
article caused a significant dose-dependant increase in the frequencies
of chromosome aberrations in the Chinese Hamster Ovary cells, both with
and without S-9 activation. One submitted study (MRID 00132169), tested
formaldehyde (37%) for Unscheduled DNA synthesis (UDS) in Primary rat
liver hepatocytes. The test material was tested at concentrations of
0.0005, 0.001, 0.005, 0.01, 0.02, or 0.04 µL/mL and found to cause no
significant increase in UDS in rat hepatocytes.

In published studies, formaldehyde has shown both positive and negative
results in the Ames Salmonella assay (Donovan et al., 1983; Connor et
al., 1983, 1985;  Frei et al., 1984; Fiddler et al., 1984; Oerstavik and
Hongslo, 1985; Takahashi et al., 1985; Schmid et al., 1986; Zielenska
and Guttenplan, 1988;  Le Curieux et al., 1993; O’Donovan and Mee
(1993) Watanabe et al., 1996; Dillon et al., 1998; Ryden et al., 2000;
Wilcox et al., 1990; Jung et al., 1992; Marnett et al., 1985; Mueller et
al., 1993).

	Temcharoen and Thilly (1983) examined the capacity of formaldehyde to
induce forward mutations to 8-azaguanine resistance in S. typhimurium TM
677, a his+ revertant of TA 1535. Both toxicity and mutagenicity were
obtained at formaldehyde concentrations of 0.17 mM in the absence of S9
and 0.33 mM in the presence of S9 Dillon et al. (1998) employed
Salmonella strains TA102 and TA104 because they are more sensitive to
oxidative mutagens. Formaldehyde was mutagenic in both strains, as well
as in TA100. However, the authors reported that the mutagenic activity
was not reduced in TA104 in the presence of S9 from either
Aroclor-induced male Fischer F 344 rats or male B6C3F1 mice.

	In another study, formaldehyde induced forward mutations to
trifluorothymidine resistance in mouse lymphoma L5178Y tk+/- cells both
in the absence and presence of rat liver S9 (higher concentrations
required for effect with S9). Both toxicity and mutagenicity were
abolished when formaldehyde dehydrogenase was incorporated in the
exposure medium (Blackburn et al., 1991).

d by formaldehyde, with SSB at concentrations greater than 200 M and
a reduction of radiation-induced breaks (indirect measure of DPX) at 50
M. Formaldehyde-induced DPX were repaired 24 hours after the compound
was removed from the culture.

	In vivo, no treatment-related increase in either micronuclei or
chromosome aberrations were observed following  intraperitoneal exposure
to formaldehyde at 0, 6.25, 12.5, or 25 mg/kg. (Natarajan et al. (1983)
).  Similarly,  chromosomal analysis of spermatocytes at metaphase I did
not reveal any chromosomal lesions in Q strain mice injected
intraperitoneally with 50 mg/kg of the compound (Fontignie-Houbrechts,
1981).   Exposure of male and female Fischer F-344 rats to 0.5, 6, or 15
ppm (0.6, 7.4, 18.5 mg/m3) formaldehyde by inhalation for 6 hours/day
for 5 days showed no increases in either SCE or chromosome aberrations
at any dose level (Kligerman et al. (1984) )  .

FQPA CONSIDERATIONS

There are no tolerances for formaldehyde or paraformaldehyde and the use
patterns considered for the reregistration eligibility decision do not
involve dietary exposure.  As a result, a FQPA safety finding is not
applicable.

DATA GAPS / REQUIREMENTS

There are no acceptable repeat dose dermal toxicity studies for
formaldehyde. Although currently there are no dermal endpoints selected,
a dermal toxicity study is considered a data gap with respect to the
dermal concentration of formaldehyde that causes systemic effects and
whether any systemic effects are precluded by the irritancy and/or
sensitization potential of the chemical.

VII. 	ACUTE TOXICITY

  Acute Toxicity data for Formaldehyde technical a.i.

Guideline Number	Study Type/ Test substance (% a.i.)	MRID

Number/ Citation	Results	Toxicity Category

870.1100

(§81-1)

Acute Oral – Guinea Pig

Purity 37.3% - Formaldehyde

00058054

LD50 = 260 mg/kg

II

870.1200

(§81-2)

Acute Dermal – Rat

Purity  37.3% - Formaldehyde

00058054

  SEQ CHAPTER \h \r 1 LD50 = 300 mg/kg

II

870.1200

(§81-2)

Acute Dermal – Rabbit

Purity  37.3% - Formaldehyde

00058054

  SEQ CHAPTER \h \r 1 LD50 = 240 mg/kg

II

870.1200

(§81-2)

Acute Dermal – Dog

Purity  37.3% - Formaldehyde

00058054

  SEQ CHAPTER \h \r 1 LD50 = 550 mg/kg

II

870.1300

(§81-3)

Acute Inhalation – Mouse and Rat

See Open Literature studies in Toxicity Profile for Formaldehyde

870.2400

(§81-4)

Primary Eye Irritation -

Purity  37.3% - Formaldehyde

00058054

Severe eye irritant

I

870.2500

(§81-5)

Primary Dermal Irritation

Purity  37.3% - Formaldehyde

00058054

Formation of vesicles with superficial necrosis or nodules.

I

870.2600

(§81-6)

Dermal Sensitization – Guinea pigs

Purity 40.0% - Formaldehyde

40161103

Extreme Sensitizer

NA

VIII. 	  SEQ CHAPTER \h \r 1 SUMMARY OF TOXICOLOGY ENDPOINT SELECTION
FOR OF FORMALDEHYDE

  SEQ CHAPTER \h \r 1 Exposure

Scenario	Dose Used in Risk Assessment

(mg/kg/day) 	Target MOE, UF,

Special FQPA SF* for Risk Assessment	Study and Toxicological Effects

Dietary Risk Assessments

Acute Dietary

(general population including infants and children) 	An acute dietary
assessment is not needed for the registered antimicrobial uses of
formaldehyde.

Chronic Dietary

(all populations)	 A chronic dietary assessment is not needed for the
registered antimicrobial uses of formaldehyde.

Non-Dietary Risk Assessments

Incidental Oral

	 An incidental oral risk assessment is not required for the registered
antimicrobial uses of formaldehyde.

Dermal  (all durations)	A dermal risk assessment is not
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 Horvath, E.P. et al. (1986): JAMA 259(5): 701-707.  Based on complaints
of eye, nose, and throat irritation in particle board workers at
concentrations of formaldehyde from 0.4 – 1.0 ppm.

Redden, J. (2005): Section 18 Emergency Exemption for the use of
Paraformaldehyde: U.S. Army Medical Research Institute of Infectious
Diseases.

Cancer	 Formaldehyde is currently classified as a  B1 (probable human
carcinogen) in EPA’s IRIS assessment. IARC has classified formaldehyde
as “carcinogenic to humans.” The Agency has decided to present the
formaldehyde cancer risks for the pesticidal uses using both the
existing 1991 IRIS cancer unit risk of 1.3 E-5 per (µg/m3) and the CIIT
BBDR model until any new cancer estimates are fully peer reviewed

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