[Federal Register Volume 83, Number 184 (Friday, September 21, 2018)]
[Proposed Rules]
[Pages 47855-47856]
[FR Doc No: 2018-20529]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-R04-OAR-2018-0073; FRL-9984-11--Region 4]

Air Plan Approval; South Carolina: Revisions to Prevention of
Significant Deterioration Rules

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule.

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SUMMARY: The Environmental Protection Agency (EPA) is proposing to
approve portions of a State Implementation Plan (SIP) revision
submitted by the State of South Carolina, through the South Carolina
Department of Health and Environmental Control (SC DHEC), on September
5, 2017, that seek to revise certain New Source Review (NSR)
regulations regarding the Prevention of Significant Deterioration (PSD)
permitting program. EPA is proposing this action pursuant to the Clean
Air Act (CAA or Act).

DATES: Comments must be received on or before October 22, 2018.

ADDRESSES: Submit your comments, identified by Docket ID No. EPA-R04-
OAR-2018-0073 at http://www.regulations.gov. Follow the online
instructions for submitting comments. Once submitted, comments cannot
be edited or removed from Regulations.gov. EPA may publish any comment
received to its public docket. Do not submit electronically any
information you consider to be Confidential Business Information (CBI)
or other information whose disclosure is restricted by statute.
Multimedia submissions (audio, video, etc.) must be accompanied by a
written comment. The written comment is considered the official comment
and should include discussion of all points you wish to make. EPA will
generally not consider comments or comment contents located outside of
the primary submission (i.e., on the web, cloud, or other file sharing
system). For additional submission methods, the full EPA public comment
policy, information about CBI or multimedia submissions, and general
guidance on making effective comments, please visit http://www2.epa.gov/dockets/commenting-epa-dockets.

FOR FURTHER INFORMATION CONTACT:  D. Brad Akers, Air Regulatory
Management Section, Air Planning and Implementation Branch, Air,
Pesticides and Toxics Management Division, U.S. Environmental
Protection Agency, Region 4, 61 Forsyth Street SW, Atlanta, Georgia
30303-8960. Mr. Akers can be reached via telephone at<PHONE_NUMBER> or
via electronic mail at [email protected].

SUPPLEMENTARY INFORMATION:

I. What action is EPA taking today?

    On September 5, 2017, SC DHEC submitted a SIP revision to EPA for
approval that involves changes to South Carolina's NSR permitting
regulations to make them consistent with federal requirements for NSR
permitting, correct typographical errors, make internal references
consistent, and update public noticing procedures.\1\ These changes
include revisions to NSR public notice requirements in SC DHEC
Regulation 61-62.5, Standard No. 7--``Prevention of Significant
Deterioration (PSD) at sections (q) and (w)(4) to address the federal
rule entitled ``Revisions to Public Notice Provisions in Clean Air Act
Permitting Programs,'' Final Rule, 81 FR 71613 (October 18, 2016) (also
referred to as the e-Notice Rule). In this proposed action, EPA is
approving the SIP revision that makes changes to South Carolina's NSR
regulations at SC DHEC Regulation 61-62.5, Standard No. 7 which applies
to the construction or modification of any major stationary source in
areas designated as attainment or unclassifiable as required by part C
of title I of the CAA, with the exception of the portions of the SIP
revision related to the e-Notice Rule. EPA has addressed the e-notice
portions of the SIP revision in a separate proposed action. See 83 FR
39638 (August 10, 2018).
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    \1\ Also on September 5, 2017, South Carolina submitted separate
SIP revisions with: Changes to Regulation 61-62.1, Section I--
``Definitions'' and Regulation 61-62.5, Standard No. 5.2--``Control
of Oxides of Nitrogen (NOX);'' the adoption of Regulation
61-62.97--``Cross State Air Pollution Rule (CSAPR) Trading
Program;'' and changes to the regional haze SIP. The SIP revision
related to Regulation 61-62.97 (CSAPR) was previously approved on
October 13, 2017 (82 FR 47939). EPA will address the remaining SIP
revisions in separate actions.
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    South Carolina's PSD regulations at Regulation 61-62.5, Standard
No. 7, were originally approved into the SIP on June 10, 1982 (47 FR
6017), with periodic revisions approved through August 10, 2017 (82 FR
37299). EPA is proposing to approve changes submitted in South
Carolina's September 5, 2017, SIP revision to modify the PSD
regulations to make minor edits for internal consistency and to adopt
changes for consistency with EPA's 2016 permit rescission rule entitled
``Rescission of Preconstruction Permits Issued Under the Clean Air
Act'' Final Rule, 81 FR 78043 (November 7, 2016) (hereinafter referred
to as the Permit Rescission Rule).

II. Background

    This proposed action seeks to revise South Carolina's PSD
regulations in the SIP as described in Section III, below. Many of
these changes are administrative in nature, including updating internal
references and correcting typographical errors. The September 5, 2017,
SIP revision also makes changes to the PSD regulations to adopt
corrective provisions from EPA's Permit Rescission Rule.
    On November 7, 2016, EPA published the Permit Rescission Rule,
which addressed the rescission of preconstruction permits for PSD. The
rule made the following changes to the Agency's PSD rule at 40 CFR
52.21: (1) Removed a date restriction that only allowed the rescission
of PSD permits issued under PSD rules in effect as of July 30, 1987;
(2) clarified that permit rescission is not automatic; and (3)
corrected an outdated cross-reference. EPA removed the July 30, 1987
date restriction from the federal rule because there are circumstances
where it may be appropriate to rescind PSD permits issued under rules
in effect after this date pursuant to the criteria in 40 CFR
52.21(w)(3) of the Permit Rescission Rule. For additional information
on provisions in the Permit Rescission Rule, see 81 FR 78043 (November
7, 2016).

III. Analysis of the State's September 5, 2017, Submittal

    The September 5, 2017, SIP revision makes several changes to
Regulation 61-62.5, Standard No. 7 at section (w)--entitled ``Permit
rescission''--to be consistent with the federal provisions for
rescinding PSD permits.\2\ Paragraph (w)(1) currently states that PSD
permits issued pursuant to Standard No. 7 remain in effect until they
expire or are rescinded. This subparagraph is revised in South
Carolina's submittal to clarify that section (w) is the only provision
under which permit rescission is allowed. Next, paragraph (w)(2) is
revised to remove the date restriction discussed in Section II, above,
that limits rescission to PSD permits issued

under PSD rules in effect on or before July 30, 1987. South Carolina's
revised language is consistent with the federal Permit Rescission Rule,
allowing for permit rescission if the permit meets the requirement of
paragraph (w)(3). Finally, paragraph (w)(3) is revised to change the
word ``shall'' to ``may'' to clarify that this provision does not
create a mandatory duty for the State. This change is consistent with
the Permit Rescission Rule at 40 CFR 52.21(w)(3).
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    \2\ South Carolina also revised 61-62.5, Standard No. 7 at
paragraph (w)(4) to address EPA's eNotice Rule. As discussed above,
EPA proposed to approve this change in a separate proposed action.
See 83 FR 39638 (August 10, 2018).
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    The September 5, 2017, SIP revision also revises other paragraphs
in Regulation 61-62.5, Standard No. 7 for consistency in formatting, to
correct internal references, and to correct typographical errors.
Section (b) is modified at paragraph (34), subparagraph (vi), to
correct a typographical error in the definition of ``Net emissions
increase.'' Next, sections (w), (aa), and (bb) are revised to be in
bold font for internal consistency. Finally, Standard No. 7 is revised
to make internal references and formatting consistent by making changes
in section (aa) at (aa)(1)(i), (aa)(9), (aa)(11)(i), and (aa)(14)(i).
EPA preliminarily finds that South Carolina's revised rules are
consistent with federal requirements and CAA section 110.

IV. Incorporation by Reference

    In this document, EPA is proposing to include in a final EPA rule
regulatory text that includes incorporation by reference. In accordance
with requirements of 1 CFR 51.5, EPA is proposing to incorporate by
reference the SC DHEC regulatory paragraphs identified above in Section
III within SC DHEC Regulation 61-62.5, Standard No. 7, entitled
``Prevention of Significant Deterioration (PSD),'' state effective on
August 25, 2017. EPA has made, and will continue to make, these
materials generally available through www.regulations.gov and at the
EPA Region 4 office (please contact the person identified in the For
Further Information Contact section of this preamble for more
information).

V. Proposed Action

    EPA is proposing to approve the changes to the SIP identified in
Section III, above, because they are consistent with the CAA and its
implementing regulations.

VI. Statutory and Executive Order Reviews

    Under the CAA, the Administrator is required to approve a SIP
submission that complies with the provisions of the Act and applicable
Federal regulations. See 42 U.S.C. 7410(k); 40 CFR 52.02(a). Thus, in
reviewing SIP submissions, EPA's role is to approve state choices,
provided that they meet the criteria of the CAA. This action merely
proposes to approve state law as meeting Federal requirements and does
not impose additional requirements beyond those imposed by state law.
For that reason, this proposed action:
     Is not a significant regulatory action subject to review
by the Office of Management and Budget under Executive Orders 12866 (58
FR 51735, October 4, 1993) and 13563 (76 FR 3821, January 21, 2011);
     Is not an Executive Order 13771 (82 FR 9339, February 2,
2017) regulatory action because SIP approvals are exempted under
Executive Order 12866;
     Does not impose an information collection burden under the
provisions of the Paperwork Reduction Act (44 U.S.C. 3501 et seq.);
     Is certified as not having a significant economic impact
on a substantial number of small entities under the Regulatory
Flexibility Act (5 U.S.C. 601 et seq.);
     Does not contain any unfunded mandate or significantly or
uniquely affect small governments, as described in the Unfunded
Mandates Reform Act of 1995 (Pub. L. 104-4);
     Does not have Federalism implications as specified in
Executive Order 13132 (64 FR 43255, August 10, 1999);
     Is not an economically significant regulatory action based
on health or safety risks subject to Executive Order 13045 (62 FR
19885, April 23, 1997);
     Is not a significant regulatory action subject to
Executive Order 13211 (66 FR 28355, May 22, 2001);
     Is not subject to requirements of section 12(d) of the
National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272
note) because application of those requirements would be inconsistent
with the CAA; and
     Does not provide EPA with the discretionary authority to
address, as appropriate, disproportionate human health or environmental
effects, using practicable and legally permissible methods, under
Executive Order 12898 (59 FR 7629, February 16, 1994).
    In addition, this proposed approval for the State of South Carolina
does not have Tribal implications as specified by Executive Order 13175
(65 FR 67249, November 9, 2000), because it does not have substantial
direct effects on an Indian Tribe. The Catawba Indian Nation
Reservation is located within the boundary of York County, South
Carolina. Pursuant to the Catawba Indian Claims Settlement Act, S.C.
Code Ann. 27-16-120, ``all state and local environmental laws and
regulations apply to the [Catawba Indian Nation] and Reservation and
are fully enforceable by all relevant state and local agencies and
authorities.'' EPA notes this action will not impose substantial direct
costs on Tribal governments or preempt Tribal law.

List of Subjects in 40 CFR Part 52

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

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

    Dated: September 10, 2018.
Onis ``Trey'' Glenn, III,
Regional Administrator, Region 4.
[FR Doc. 2018-20529 Filed 9-20-18; 8:45 am]
 BILLING CODE 6560-50-P


July 25, 2006

Mr. Phillip Carlson (ASD)

U.S. Environmental Protection Agency

Office of Transportation and Air Quality

2000 Traverwood Drive

Ann Arbor, Michigan 48105-2498

Dear Mr. Carlson,

I am writing to provide comments about the evaporative emission controls
being proposed for the marine fuel systems.  I attended the SBREFA
meeting held in Ann Arbor, MI on July 11, 2006 and these comments are a
repeat of my verbal comments at that meeting.  I am employed by
Grady-White Boats in Greenville, NC. We employ about 450 people.
Grady-White builds coastal saltwater fishing vessels for recreational
use sized from 18’ to 36’.  Our boats are 100% outboard powered.
Our fuel tanks are all permanently installed.

The majority of boat builders in the US are small business entities.
North Carolina has over 100 boat builders and I believe only about four
of these employ more than 500 people, therefore, most are small
businesses like Grady-White Boats.  I believe this general business size
will be fairly normal across the U.S.

Certified Components and Reference Standards

Allow flexibility by the use of certified components and reference
standards to meet the regulations.  The USEPA will have a tremendous job
just communicating these new regulations due to the large number of very
small manufacturers in the boat building industry.  I would estimate
that about 95% of the boat builders in the US are not even aware of
these proposed regulations.

The large number of small shops would make it very difficult and
expensive to test every individual model.  Grady-White Boats (GWB)
currently manufactures 20 different models, averaging less than 100
units, per model, per year.  Use of existing “standard writing
organizations”, such as the USCG and ABYC to establish acceptable
systems and installation guidelines will greatly simplify the process.
Use of components tested (and labeled as meeting the EPA’s
requirements) will again ease the burden on the small businesses that
prevail in the marine industry.  Carbon canister volumes should be
specifically designated based on fuel tank capacity.

 Another benefit of the use of certified components and reference
standards is to eliminate the need for any record-keeping, reporting,
and paperwork associated with these regulations.  Government required
paperwork is a burden to all businesses, but especially the small
businesses.

Canister Sizes for Larger, Non-Trailerable Boats

The larger boat models have a much higher fuel capacity than the average
size tanks the EPA has been testing.  GWB’s largest model is a 36’
boat with a total gasoline fuel capacity of 370 gallons.  Our 33’ has
350 gallons of capacity.  Our 30’s (three different models) hold
between 290 and 306 gallons.  Our 27’ and 28’ models (three
different models) have 205 gallon tanks.  Since most of these larger
boats are stored in the water the diurnal emissions are greatly reduced
when compared to the smaller, trailerable boats.  Diurnal temperature
swings experienced on the larger boats (with built-in tanks) that remain
in the water are much different than those of smaller boats stored on
trailers.  The required volume of carbon for these larger boats may be
less than needed for the smaller trailerable boats to control the
diurnal emissions.  Finding space to locate the proposed 14.8 liters of
carbon that would be required for 370 gallons of fuel becomes a
challenge in and of itself.  If this much is not really needed due to
reduced diurnal swings, allow flexibility in the rules to reflect the
reduced need.  Testing should be performed to establish the true
temperature swings experienced by boats stored in-water.

Most boats about 25’-26’ in length become more difficult to use as
trailer-boats due to the beam increasing to above 8’ 6”. Most states
require special permits to move these boats on the highways.  The USFWS
has a grant program that provides funding for infrastructure for
“non-trailerable, transient boats” and they designate boats 26’
and above as non-trailerable in this program.  (50 CFR Part 86.12)  This
grant program is called Boating Infrastructure Grant Program (BIG-P).
The EPA may want to consider using these same guidelines to establish
the baseline for boats mostly stored in-water.

Per Component Cost Disadvantage

Another issue smaller businesses face is the pricing disadvantage of
small/low volume usage of components.  Larger companies building 40,000+
boats a year are going to be able to negotiate a better price per
canister (and other components) than the small builders purchasing less
than 2000-3000/ year.

Inaccurate Cost Evaluations

The proposal contains cost estimations that do not appear to be accurate
based upon our research.

Cost of hose configurations is too low.  All of the lengths stated as
“typical” in table 2-1 of the draft are much shorter than our
typical lengths.  About 25% of our 20 models are purchased with dual
tanks as standard and another 20% of the model line is offered with an
optional second auxiliary tank.  Averaging the total lengths of fuel
hoses across the model line gives us the following averages.  Models
with optional tanks were averaged with the main tank hoses only.

				GWB Avg		EPA Table 2-1

Fuel Fill hose- 			10.5’			5.8’

Fuel Vent hose- 		10.5’			7.5’

Fuel Supply hose- 		31.4’			6.5’

It is clear that the hose lengths used in the cost comparison are about
two to almost five times shorter than our actual average length.

The systems set up for the carbon canister test program in 2005 used
Racor fuel/air separator (Racor part # LG-50) that cost about $50 each,
not the $2 shown in the Draft cost estimates on page 16.

Carbon canisters for the tested systems installed on our boats last year
also required four clamps per tank at $0.279 each versus the two at
$0.20 each as shown in the EPA estimate.

Additional hose was required - 6’ of fuel vent hose per tank at $0.435
per foot.

We also used a piece of poly to cover the area in front of the
canisters.  The project boat used four square feet at $3.24 per SF.
Total cost of $12.96.  This was the method we chose for the test boat,
but every model will need some kind of hatch or coverboard allowing
access and a mounting surface or both.  None of this cost was addressed
in the EPA estimates.

Canister costs were estimated to be about $38 for a 100 gallon tank.
Projected costs of the canisters given to us range from $25 to $200.
The $25 figure assumes that every builder will use common sized
canisters and there will be only a few different designs offered
nationwide.  Design restrictions and larger tank capacities will more
than likely draw this cost up to approximately $80 to $150 per canister
based on our best estimate.  This is difficult to price accurately due
to unknown factors regarding canister volumes and space/design
limitations.

On larger boats, with offshore capabilities, most have dual fuel
tanks/systems.  On these models the total cost is doubled!

Molded Tank Costs

Current tank suppliers state the EPA cost projections of the proposed
treatment or coating is too low and that current technologies are
unproven.  Our molded tanks are 60 and 82 gallons each.

Drop box molding costs have been estimated to be about $5000 per mold by
the current tank molders, not the $1000 estimated by the EPA.  The
amortized cost per part is therefore five times higher than the EPA
estimate in the proposal.  These tanks are normally manufactured at a
volume of about 100 tanks per year.

Cost of epoxy coatings are estimated at $6 to $7 per pound by the EPA.
Tank molders estimate the current cost of the material at $12- $15 per
pound.

Shipping cost per tank for this treatment is estimated at $0.30 to $1.00
per tank which is unreasonable considering the size of our current
tanks.  Currently, a letter costs $0.39 to mail in the USPS.  There is
no method to ship a 60 to 80 gallon tank for $1.00 or less.

The multi-layered system is not field proven in marine applications.  No
boat builder is currently installing multi-layered tanks.  According to
the one supplier who states they have designed a process to successfully
produce multi-layered tanks, the cost increase per tank is about 50% of
current tanks. This represents an increase for Grady-White’s per tank
cost of at least $70.  The current lack of tested and field-proven tanks
using new construction materials and methods requires flexibility and
careful consideration by the EPA for sufficient field testing.

Need to Develop New Plastic Materials

The small businesses (tank molders and boat builders) do not have the
clout or volume to push plastic resins/material design onto companies
such as Phillips or Exxon.  The USEPA needs to push the development of a
new material that will be cost equivalent to current materials or at
least very close.  This gap also shows the need to set a technology
review date in the future.  It is necessary to assure advancements are
occurring that will provide acceptable materials to be developed.   The
review should include consideration of the material’s cost,
feasibility, and the lead-time needed to make a conversion from present
materials.

Tooling Modification or Replacement

One of the largest single expenses resulting from requiring the use of
carbon canisters is completely ignored by the EPA’s cost estimates-
tooling redesign or modification costs.   All fuel connections and
fittings are required to be readily accessible for inspection.  Any
additional components or connections created by use of canisters must
meet this requirement.  Molds (or “tooling”) will need to be
redesigned to accept some type of access door or hatch.

Grady-White currently manufacturers 20 different models and there are
potentially 31 deck and liner molds that could require modification to
incorporate access.  This cost would be very high as modifications to
tooling are expensive and not very durable.  The initial cost and
long-term maintenance cost associated with extensive modifications need
to be added to the cost estimation.

Flexibility should be built in to allow sufficient time to modify and/or
replace existing tools.  Many smaller builders will utilize a mold for
seven or more years before a redesign occurs.  Even large volume boat
builders will utilize tooling for at least five years before replacing
tooling with newer designs.  Small businesses will require flexibility
to work through these modifications/replacements without causing undue
financial hardship.

Thanks for the opportunity to provide input regarding the proposed
regulations.  It is critical for our business that we have a clean and
healthy environment.   I look forward to continuing to provide input to
the USEPA and would ask that you contact me if you have any questions.
  HYPERLINK<EMAIL_ADDRESS><EMAIL_ADDRESS>
Phone:<PHONE_NUMBER>.

Sincerely,

Jim Hardin

Compliance Manager

Grady-White Boats, Inc.

PO Box 1527

Greenville, NC 27835-1527


EPA Registration Division contact: Laura Nollen,<PHONE_NUMBER>

Interregional Research Project Number 4 (IR-4)

Petition Number 0E7723

EPA has received a pesticide petition, PP # 0E7723, from IR-4, 500
College Road East, Suite 201W, Princeton, NJ 08540, proposing, pursuant
to section 408(d) of the Federal Food, Drug, and Cosmetic Act, 21 U.S.C.
346a(d), to amend 40 CFR 180.598 by establishing a tolerances for
residues of novaluron, N-[[[3-chloro-4-[1,1,2-trifluoro-2-
trifluoromethoxy)ethoxy]phenyl]amino]carbonyl]-2,6-difluorobenzamide, in
or on corn, sweet, kernals plus cob with husks removed at 0.05 parts per
million (ppm); corn, sweet, forage at 20 ppm; and corn, sweet, stover at
50 ppm, and to increase the established livestock tolerances for
residues of novaluron in or on milk from 1.0 to 1.5 ppm, and milk fat
from 20 to 35 ppm, respectively.

Makhteshim-Agan of North America, Inc., 4515 Falls of Neuse Road,
Raleigh, NC 27609, is the manufacturer and basic registrant of
novaluron. Makhteshim-Agan of North America, Inc., prepared and
summarized the following information in support of the subject pesticide
petition for novaluron. EPA has determined that the petition contains
data or information regarding the elements set forth in section
408(d)(2) of the FFDCA. However, EPA has not fully evaluated the
sufficiency of the submitted data at this time or whether the data
supports granting of the petition. Additional data may be needed before
EPA rules on the petition.

A.	Residue Chemistry

1.    Plant and Livestock Metabolism

	The qualitative nature of the residue of novaluron in plants is
adequately understood based on acceptable plant metabolism studies
reflecting its uses on apples, cabbage, cotton, and potatoes. These
plant metabolism studies have demonstrated that novaluron does not
metabolize and is non-systemic (does not translocate within the plant).
The results observed in the plant and livestock metabolism studies show
similar metabolic pathways. The residue of concern, which should be
regulated, is the parent compound, novaluron, only.

2.	Analytical Method

An adequate analytical enforcement method, gas chromatography/electron
capture detector (GC/ECD) and a high performance liquid
chromatography/ultraviolet method (HPLC/UV) for enforcing tolerances of
novaluron residues in or on different matrices are available, as
published in the Federal Register of January 27, 2010 (Volume 75, Number
17; FRL-8807-2).

A method validation was conducted both prior to sample analysis and
concurrently with sample analysis determining that the method recoveries
were in the range. The Limit of Quantitation (LOQ) for the method in
K+CWHR, forage and stover was calculated to be 0.040, 0.052 and 0.049
ppm, respectively. The lowest level of method validation (LLMV) for
novaluron in corn forage, stover and K+CWHR was 0.05 ppm.

3. 	Magnitude of Residues

Fourteen field trials were conducted with Rimon 0.83 EC in sweet corn at
the supported use pattern of five foliar applications at a maximum rate
of 12 fl. oz product/A, or 0.088 lb ai/A at 7-day intervals (for a total
seasonal rate of 60 fl. oz of Rimon 0.83EC), and a PHI of 1 day covering
NAFTA and PMRA Growing Regions 1 (2 trials), 2 (1 trial), 3 (1 trial), 5
(5 trials), 5B (1 trial), 7A (1 trial), 10 (1 trial), 11 (1 trial), and
12 (1 trial) during the 2007 season. Measured novaluron residues taken
at 1 day PHI range from less than 0.05 ppm in kernals plus cob with husk
removed (K+CWHR), 0.35 ppm to 15.03 ppm in forage, and 0.35 ppm to 52.06
ppm in stover. The proposed tolerances for corn, sweet (K+CWHR) are 0.05
ppm, forage 20 ppm, and stover 50 ppm based on the MRL calculator.

B.	 Toxicological Profile

	1.   	Acute Toxicity

In an acute oral toxicity study in rats, novaluron had an LD50 >5,000
mg/kg.  A dermal toxicity study in rats resulted in an LD50 greater than
2,000 mg/kg.  The LC50 for acute inhalation in rats was greater than
5.15 mg/l.  In rabbits, novaluron is not a skin irritant, but it is a
mild eye irritant.  Novaluron is not a sensitizer in guinea pigs.

		2.	  Genotoxicity

The mutagenic potential of Novaluron was investigated in several in vivo
and in vitro studies.  Results in two Ames assays, an in vivo mouse
micronucleus assay, an in vitro unscheduled DNA synthesis (UDS) assay,
an in vitro cell mutation assay, and an in vitro human lymphocyte
clastogenicity test were negative.  Novaluron is therefore considered to
have no potential to induce mutagenicity.

		3.    Reproductive and Developmental Toxicity

	i.   A two generation rat reproduction study was conducted with dose
levels of 1,000, 4,000, and 12,000 ppm (74.2, 297.5, 894.9 mg/kg/day,
and 84, 336.7, 1,009.8 mg/kg/day for males and females, respectively).
Maternal and offspring toxicity was evidenced by increased absolute and
relative spleen weights, whereas reproductive toxicity was observed only
in males at 297.5 mg/kg/day (LOAEL) based on decreased epididymal sperm
counts and increased age at preputial separation in the F1 generation.
The no observed adverse effect level (NOAEL) in males was 1,000 ppm
(74.2 mg/kg/day) and in females it was $12,000 ppm (1,009.8 mg/kg/day).

	ii.   Teratology studies were conducted in the rat and rabbit.  No
treatment-related mortalities were observed in either study.  No effect
on survival, development or growth of fetuses was noted in either
species in either study.  No maternal or developmental toxicity was
observed up to and including the limit dose of 1,000 mg/kg/day (NOAEL).
These two studies demonstrate that novaluron was not teratogenic in
either rats or rabbits.

		4.	Subchronic Toxicity

Rats, mice and dogs all show the same toxicologic response.  Generally,
 novaluron induces small increases in methemoglobin; red cells are
sequestered; and, compensatory hematopoiesis occurs.  The severity of
these changes is well within the physiological capacity of the animals
and is judged   not adverse.

Rats treated topically with novaluron in a 28-day study at 0, 75, 400
and 1,000 mg/kg/day did not show signs of systemic toxicity.  Small
treatment-related increases in methemoglobin were seen in both sexes at
1,000 mg/kg/day and in females at 400 mg/kg/day.  The highest
methemoglobin value seen in females was 1.28% compared with 0.86% in
controls.  Organ weights, macroscopic and microscopic examination of
organs and tissues did not reveal any treatment-related changes.

Two 13-week rat studies were conducted.  In one study, doses were
administered at 50, 100, 200, 400 ppm (3.52, 6.93, 13.83, 27.77
mg/kg/day and 4.38, 8.64, 17.54 and 34.39 mg/kg/day for males and
females, respectively). The LOAELs from the combined results were 27.77
mg/kg/day in males based on increased occurrence of extramedullary
hematopoiesis and hemosiderosis in spleen; and 8.64 mg/kg/day in females
based on reduction in hemoglobin, hematocrit and RBC count; increased
occurrence of extramedullary hematopoiesis and hemosiderosis in spleen
and liver.  The NOAEL was determined to be 4.38 mg/kg/day.

A 13-week mouse study was conducted with dose levels of 30, 100, 1,000,
10,000 ppm (4.2, 12.8, 135.9, 1,391.9 and 4.7, 15.2, 135.6, 1,493.1
mg/kg/day, for males and females, respectively).  The NOAEL was
determined to be 100 ppm (12.8 and 15.2 mg/kg/day, male and females,
respectively).  The LOAEL was 1,000 ppm (135.9 and 135.6 mg/kg/day,
males and females, respectively) based on increased body weight gain,
low erythrocyte counts, and secondary splenic changes.  There were no
clinical treatment-related signs noted.

Two 13-week dog studies were conducted.   One study resulted in an NOAEL
of 100 mg/kg/day and a LOAEL of 300 mg/kg/day based on low erythrocyte
counts and secondary splenic and liver changes.  No clinical
treatment-related signs were noted.  Another study, was conducted using
only one dose level of 10 mg/kg/day.  There were no clinical or
histopathological treatment-related signs and the NOEL was determined to
be 10 mg/kg/day.

		5.	Chronic Toxicity

	i.    Chronic toxicity and oncogenicity was evaluated in the rat, mouse
and dog.  The rat chronic toxicity and oncogenicity was conducted with
dose levels of 25, 700, 20,000 ppm (1.1, 30.6, 884.2 and 1.4, 39.5,
1,113.5 mg/kg/day for males and females, respectively).  The LOAEL in
male and female rats was 30.6 and 39.5 mg/kg/day, respectively, based on
evidence of erythrocyte damage and turnover resulting in a regenerative
anemia in both sexes. The corresponding NOAEL was 25 ppm (1.1 and 1.4
mg/kg/day for male and female rats, respectively). There was no evidence
of carcinogenicity in this study.  A mouse chronic toxicity study was
conducted with dose levels of 30, 450, 7,000 ppm (3.6, 53.4, 800.0 and
4.3, 63.3, 913.4 mg/kg/day for males and females, respectively).  The
LOAEL in male and female mice was 53.4 and 63.3 mg/kg/day, respectively,
based on erythrocyte turnover due to hemoglobin oxidation and resulting
in a compensated anemia. The corresponding NOAEL was 30 ppm (3.6 and 4.3
mg/kg/day for male and female mice, respectively). There was also no
evidence of carcinogenicity in this study.  Chronic toxicity was
investigated in dogs using dose levels of 10, 100, 1,000 mg/kg/day.  The
NOAEL of 100 mg/kg/day was based on methemoglobin.

		ii.  	The chronic reference dose (cRfD) of 0.011 mg/kg/day has been
established on the basis of the chronic carcinogenicity study in rats.
An uncertainty factor (UF) of 100 was applied to the NOAEL of 1.1
mg/kg/day for male rats deriving to the cRfD.

 		iii. 	 In accordance with the EPA Draft Guidelines for Carcinogen
Risk Assessment (July 1999), novaluron is classified as not likely to be
carcinogenic to humans due to results of oncogenicity studies that show
no evidence of carcinogenicity in rats and mice.

		6.	Animal Metabolism

Metabolism studies in rats and goats were conducted with the parent
material labeled in both the difluorophenyl and chlorophenyl moieties.
Rats absorb little novaluron when it is administered orally.  More than
90% of the dietary administered [chlorophenyl 14C(U)] novaluron is
recovered in the feces.  When the diflurophenyl ring of the molecule is
labeled, the recovered 14C activity in the feces is lower but still
above 75%.  The difference is thought to reflect intestinal metabolism
by microbial flora and the higher absorption of the diflurophenyl
metabolites.

The parent molecule as well as its degradates are absorbed from the
gastrointestinal tract.  All parent material is metabolized either upon
initial entry into the systemic circulation or, if sequestered to the
fat, upon its depuration back to the systemic circulation.  There is no
intact novaluron found in the urine. Novaluron=s high octanol-water
partition coefficient is responsible for its preferential movement to
fat.  The half-life in fat calculated from the rat metabolism study is
approximately 55 hours.

Two groups of metabolites are formed after oral administration of
novaluron.  One group is typified by the aniline metabolite
3-chloro-4-(1,1,2-trifluoro-2-trifluoromethoxyethoxy) aniline, referred
to as 3-TFA.  The other group of metabolites is typified by
2,6-difluorobenzoic acid is from the diflurophenyl moiety of the
molecule.  Nearly all the metabolites are formed at a level of 1% or
less of the applied dose.  They are rapidly excreted.

The metabolism in goats and hens mimics that seen in rats.

	7.     Metabolite Toxicology

Makhteshim-Agan of North America Inc., has determined that there are no
metabolites of toxicological concern and therefore, no metabolites need
to be included in the tolerance expression and require regulation. For
drinking water assessment the soil degradates, chlorophenyl urea and
chloroaniline will be included besides the parent, novaluron.

8.    Endocrine Disruption

No special studies investigating potential estrogenic or other endocrine
effects of novaluron have been conducted.  However, inspection of
in-life data from toxicology studies does not indicate that novaluron is
an endocrine disruptor.  Specifically, endocrine organ weights (e.g.,
thyroid, testes, ovaries, pituitary from the two-generation study) were
not adversely affected by novaluron.  Milestones of sexual development
were not affected by novaluron; and, reproduction was not adversely
affected.  Based on these observations, there is no evidence to suggest
that novaluron has an adverse effect on the endocrine system.

C.   Aggregate Exposure

	1.	Dietary Exposure

Tolerances have been established (40 CFR 180.598) for the residues of
novaluron, in or on the following raw agricultural commodities: Apple,
wet pomace at 8.0; Brassica, head and stem, subgroup 5A at 0.5 ppm;
cattle, fat at 11 ppm; cattle, fat at 11 ppm; cattle, kidney at 1.0 ppm;
cattle, liver at 1.0 ppm; cattle, meat at 0.60 ppm; cattle, meat
byproducts, except liver and kidney at 0.60 ppm; cotton, gin byproducts
at 30 ppm; cotton, undelinted seed at 0.60 ppm; egg at 0.05 ppm; fruit,
pome, group 11 at 2.0 ppm; goat, fat at 11 ppm; goat, kidney at 1.0 ppm;
goat, liver at 1.0 ppm; goat, meat at 0.60 ppm; goat, meat byproducts
except liver and kidney at 0.60 ppm; hog, fat at 0.05 ppm; hog, meat at
0.01 ppm; hog, meat byproducts at 0.01 ppm; horse, fat at 11 ppm; horse,
kidney at 1.0 ppm; horse, liver at 1.0 ppm; horse, meat at 0.60 ppm;
horse, meat byproducts, except liver and kidney at 0.60 ppm; milk at 1.0
ppm; milk, fat at 20 ppm; poultry, fat at 0.40 ppm; poultry, meat at
0.03 ppm; poultry, meat byproducts at 0.04 ppm; sheep, fat at 11 ppm;
sheep, kidney at 1.0 ppm; sheep, liver at 1.0 ppm; sheep, meat at 0.60
ppm; sheep, meat byproducts, except liver and kidney at 0.60 ppm,
sugarcane, cane at 0.50 ppm; vegetables, tuberous and corn, subgroup 1C
at 0.05 ppm; vegetable, fruiting, group 8 at 1.1 parts per million
(ppm); vegetable, cucurbit, group 9 at 0.25 ppm; berry, low growing,
subgroup 13-07G at 0.50 ppm; cocona at 1.1 ppm; eggplant, African at 1.1
ppm; eggplant, pea at 1.1 ppm; eggplant, scarlet at 1.1 ppm; goji berry
at 1.1 ppm; huckleberry, garden at 1.1 ppm; martynia at 1.1 ppm;
naranjilla at 1.1 ppm; okra at 1.1 ppm; roselle at 1.1 ppm; sunberry at
1.1 ppm; tomato, bush at 1.1 ppm; tomato, currant at 1.1 ppm; tomato,
tree at 1.1 ppm; bean, snap, succulent  at 0.60 ppm;  bean, dry  at 0.20
ppm; and Swiss chard at 12 ppm.

This assessment estimated the chronic dietary exposures associated with
the proposed use of novaluron on sweet corn in addition to all pending
and registered crops. EPA is presently reviewing MANA’s petition (PP#
0F7708) concerning the pending tolerances of novaluron in or on all food
commodities in food handling establishments (FHE), where food products
are held, processed or prepared, as well as the pending tolerance of
novaluron in or on grain sorghum, which are also included in this
dietary exposure assessment. In this assessment, average residues from
field trials were used for most food crops and anticipated residues were
estimated for meat, milk, poultry and eggs.  The exceptions were sweet
corn (K+CWHR), cotton seed commodities (other than cotton gin
byproducts) and dried plums (prunes), for which tolerance-level residues
were assumed.  For the proposed FHE use, an estimated residue of 0.005
ppm (½ LOQ) was assumed only for each food without a tolerance
representing EPA’s approach for including FHE tolerances in chronic
dietary assessments. Market projections concerning the percent crop
treated for all crops were used to produce a conservative yet refined
estimate of chronic dietary exposures.

		i. 	Food

		a.   Acute Dietary Exposure. No toxicological endpoint attributable to
a single exposure was identified in the available toxicology studies,
including the rat and rabbit developmental studies.  Therefore, the
acute aggregate risk is negligible.

b.   Chronic Dietary Exposure.  A chronic dietary risk assessment was
conducted using the Dietary Exposure Evaluation Model (DEEM) software
with the Food Commodity Intake Database (DEEM-FCIDTM Version 2.16),
which incorporates consumption data derived from the 1994 - 1998 USDA
Continuing Surveys of Food Intake by Individuals (CSFII). The assessment
included all uses (existing, pending and proposed), assuming provided
percent crop treated estimates at market maturity. A dietary exposure
assessment conducted with the assumption of 100% crop treated is quite
conservative, even when average residues from field trials are assumed.
In order to produce a more accurate estimate of exposures, a refined
assessment using best estimates of the percent crop treated at market
maturity for all registered, pending and proposed commodities has been
conducted assuming the following percent crop treated estimates at
market maturity: cucurbits (18%), fruiting vegetables (14%), low growing
berries (12%), dry beans (16%), snap beans (12%), Swiss chard (15%),
grain sorghum (1%), stone fruit (20%), bushberries (15%), leafy brassica
vegetables (20%), turnip greens (15%), apples (30%), pears (50%), head
and stem brassica (30%), tuberous and corm vegetables (18%), cotton
(12%), sugarcane (28%), and sweet corn (12%). These percent crop treated
numbers provide a more refined estimate of potential chronic dietary
exposures to novaluron.  Concerning the pending FHE use, all eligible
food items are assumed to have novaluron residues (i.e., 100% crop
treated is assumed for all foods for which the FHE tolerance is
applicable).

Anticipated residues in animal tissues (i.e., meat and milk) were
calculated using standard methodology based on recent guidance for
calculating the maximum reasonably balanced diets (MRBD) consisting of
multiple treated feed items. Average residues in animal feed items were
used in all calculations, with the exception of cotton seed commodities
(seed, meal, hulls), for which the tolerance (0.6 ppm) was used.

The chronic population adjusted dose (cPAD) for novaluron is 0.011
mg/kg/day, based upon the NOAEL of 1.1 mg/kg/day from the chronic
carcinogenicity study in rats, and an UF of 100. The chronic dietary
exposure, including drinking water, for the general U.S. population is
0.000746 mg/kg/day, or 6.8% of the cPAD. These chronic dietary exposure
estimates account for 4.5% to 24.1% of the cPAD. The most highly exposed
subpopulation, children aged 1 to 2 years, has an estimated total
novaluron exposure of 0.002649 mg/kg/day, which corresponds to 24.1% of
the cPAD.  Chronic dietary exposures less than 100% of the cPAD are not
of concern. The total chronic dietary exposures associated with all
pending, registered and proposed uses of novaluron accounts for less
than the cPAD (0.011 mg/kg/d), and therefore is of no concern.  Thus,
exposures associated with the proposed use of novaluron on sweet corn,
in addition to all current pending and registered uses are not of
concern.

c.   Novaluron was classified as “not likely to be carcinogenic to
humans.''. Therefore, a quantitative cancer risk assessment was not
conducted.

ii.     Drinking Water

Acute Exposure. Since no acute dietary endpoint was determined,
Makhteshim-Agan of North America, Inc., concludes there is reasonable
certainty of no harm from acute drinking water exposure.

Chronic Exposure. Novaluron residues in drinking water were included in
the dietary exposure assessment.  Since there are currently insufficient
monitoring data to characterize novaluron residues in drinking water,
modeling approaches were used to estimate chronic concentrations in
surface and ground water.  The residues of concern in drinking water are
novaluron and its chlorophenyl urea and chloroaniline degradates. The
Agency used screening level water exposure models in the dietary
exposure analysis and risk assessment for novaluron and its degradates
in drinking water, as reported in the January 27, 2010, Federal Register
Notice (EPA–HQ–OPP–2009–0273; FRL–8807–2).  The Pesticide
Root Zone Model/Exposure Analysis Modeling System (PRZM/EXAMS) was used
for parent novaluron in surface water, and the First Index Reservoir
Screening Tool (FIRST) for chlorophenyl urea and chloroaniline
degradates in surface water, the Screening Concentration in Ground Water
(SCI-GROW) model for novaluron, chlorophenyl urea and chloroaniline in
ground water. The estimated drinking water concentrations (EDWCs) of
novaluron, chlorophenyl urea, and chloroaniline for chronic exposures
for non-cancer assessments are 0.76 parts per billion (ppb), 0.89 ppb
and 2.6 ppb, respectively, for surface water and for ground water 0.0056
ppb, 0.0045 ppb and 0.0090 ppb, respectively. The highest drinking water
concentrations were estimated for surface water. Of the three EDWC
values for surface water, the chronic EDWC for the terminal metabolite,
chloroaniline, is the highest (assuming 100% molar conversion from
parent to aniline). This estimate is based on the total annual
application rate of 0.96 lb ai/A on apples. The proposed sweet corn use
has a total annual application rate of 0.4 lb ai/A, and all other uses
have total annual application rates of 0.24 lb ai/A, so the estimated
drinking water residue for the use on apples will continue to be the
highest and most conservative value. Therefore, the drinking water
residue estimated by EPA for the use on apples (2.6 ppb) was used as the
worst case in this assessment.

		2.	Non-Dietary Exposure

Novaluron’s proposed use for the following residential non-dietary
sites: Indoor and outdoor control of roaches, and crickets for spot,
crack and crevice treatments, is presently under review by the Agency.
Based on EPA’s Standard Operating Procedures for Residential Exposure
Assessments, the residential post-application exposures to novaluron
residues from crack and crevice applications were taken into
consideration as the worst-case scenario at the maximum dilute
application rate of 0.25% novaluron, where short- and intermediate-term
residential post-application exposures resulted in acceptable Margins of
Exposures (MOEs), and a clear indication of reasonable certainty of no
harm.  Thus, based on the crack and crevice treatment all of the route-
and product-specific MOEs were greater than 100, and the aggregate MOEs
were greater than 100 for all population subgroups, demonstrating a
reasonable certainty of no harm.

D.	Cumulative Effects

To Makhteshim-Agan of North America’s Inc., knowledge, there are
currently no available data or other reliable information indicating
that any toxic effects produced by novaluron would be cumulative with
those of other chemical compounds; thus only the potential risks of
novaluron have been considered in this assessment of its aggregate
exposure.

E.	 Safety Determination

   	1.     U.S. Population

No acute aggregate risk assessment was conducted because there is no
toxicological endpoint attributable to a single exposure.  A chronic
aggregate risk assessment was performed based on potential exposure from
food and drinking water, considering all existing and proposed uses.
Short- and intermediate-term aggregate risk assessments were performed
based on potential exposure from food and drinking water from existing
uses, as well as the proposed spot, crack and crevice, and outdoor
perimeter uses. No cancer aggregate risk assessment was conducted
because novaluron has not been shown to be carcinogenic.

The chronic dietary exposure, including drinking water, for the general
U.S. population is 0.000746 mg/kg/day, or 6.8% of the cPAD.  The chronic
dietary exposures account for 4.5% to 24.1% of the cPAD (0.011
mg/kg/day) depending on the population subgroup. The calculation for the
most sensitive population subgroup (children 1 to 2 years old) is
0.002649 mg/kg/day, utilizing 24.1% of the cPAD.  In view of these
assessments, Makhteshim-Agan of North America Inc., concludes that there
is reasonable certainty that no harm will result from the proposed use
of novaluron on sweet corn.

         Concerning the aggregate assessment from all potential sources
of exposure (food, water, crack and crevice post-application), it has
been demonstrated that the aggregate MOEs associated with the existing
and proposed uses of novaluron do not exceed the Agency’s level of
concern. Based on these assessments, Makhteshim-Agan of North America
Inc., concludes that novaluron does not pose a risk due to short- and
intermediate-term aggregate exposure.

		2.	 Infants and Children

Section 408 of FFDCA provides that EPA may apply an additional safety
factor for infants and children to account for prenatal and postnatal
toxicity and the completeness of the database. The toxicology database
for novaluron is complete including acceptable data from rat and rabbit
developmental toxicity studies and a two generation rat reproduction
study that have been used to assess the potential for increased
sensitivity of infants and children. The data provided no quantitative
or qualitative evidence of increased susceptibility of rats or rabbits
to in utero and/or postnatal exposure to novaluron. In addition, there
is no concern for developmental neurotoxicity resulting from exposure to
novaluron, and a developmental neurotoxicity study is not required.
Therefore, the Agency determined to reduce the FQPA Safety Factor to 1X
(Federal Register of June 2, 2004; 69 FR 31013; FRL-7359-2). Thus, the
chronic population adjusted dose (cPAD) is considered 0.011 mg/kg/day.
The DEEM analysis regarding the aggregate chronic exposure calculations
utilizes less than 24.1% of the cPAD for the most sensitive subgroup,
children 1 to 2 years old. In addition, it is evident that short- and
intermediate-term aggregate residential exposures, based on the crack
and crevice treatment as the worst case for post-application exposures,
result in MOEs greater than 100.

Based on this information Makhteshim-Agan of North America Inc.,
concludes that there is reasonable certainty that no harm will result to
infants and children from aggregate exposure to novaluron residues
associated with existing and proposed uses including the proposed use of
novaluron on sweet corn.

F.	International Residue Limits

At present, no Canadian, Mexican, or CODEX maximum residue limits (MRLs)
are established for novaluron on sweet corn. Therefore, international
harmonization is not an issue at this time.

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