              OFFICE OF CHEMICAL SAFETY
AND POLLUTION PREVENTION
                 UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
                            WASHINGTON, D.C.  20460
              OFFICE OF CHEMICAL SAFETY
AND POLLUTION PREVENTION
                 UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
                            WASHINGTON, D.C.  20460

                                August 30, 2017
MEMORANDUM

SUBJECT:	Etoxazole: Estimated Drinking Waters Concentrations for Etoxazole, and Its Transformation Products R-8 and R-13, for the Use in the Human Health Risk Assessment: New Uses on Sweet Corn and Various Crop Group Conversions
		(PC Code 107091; DP Barcode 440694)

FROM:	José Meléndez, Chemist
		Environmental Risk Branch 5
		Environmental Fate and Effects Division (7507P)

THRU:	Mah T. Shamim, Ph.D., Branch Chief
            Environmental Risk Branch 5
		Environmental Fate and Effects Division (7507P)

TO:		Marianne Lewis, Risk Manager Reviewer
      Venus Eagle, Product Manager #1
		Meredith Laws, Branch Chief
		Invertebrate-Vertebrate Branch 3

		Sidney Jackson, Risk Manager Reviewer
      Dan Rosenblatt, Acting Branch Chief
		Minor Use and Emergency Response Branch
		Registration Division (7505P)

AND:		Jennifer R. Tyler, Risk Assessor
      Christine Olinger, Acting Branch Chief
		Registration Action Branch 1
		Health Effects Division (7509P)

This memo presents the Environmental Fate and Effects Division (EFED) Tier I Estimated Surface and Ground Drinking Water Concentrations (EDWCs) for etoxazole and its transformation products R-8 and R-13, calculated using the Tier I surface water model FIRST and the Tier I/II groundwater model PRZM-GW (in the tier I mode), for use in the human health risk assessment.  The registrant, Valent U.S.A. Corporation, submitted a petition to use the chemical on sweet corn in the end-use products Zeal[(R)] WP Miticide (EPA Reg. No. 59639-138) and Zeal[(R)] SC Miticide (EPA Reg. No. 59639-202).  Various crop group conversions were also petitioned.

Based on an inspection of the uses of etoxazole, it was found that the previously modeled crop `mint' represents the scenario with the highest exposure and consequently the highest surface water EDWCs (with a maximum single application rate of 0.18 lb a.i./A/application x two applications/season or 0.36 lb a.i./A/season).  Additionally, in a previous Drinking Water Assessment (DWA), groundwater EDWCs were calculated for the currently approved highest rate of 0.135 lb a.i./A x 2 applications for the use on corn.  Therefore, the EDWCs do not change from the previous ones presented in a previous DWA dated March 31, 2015 (DP Barcode 426353).

The Tier I EDWCs for etoxazole and for its major transformation products R-8 and R-13 [which were modeled as per the request of the Metabolism Assessment Review Committee (MARC) in 2003; DP Barcode 288817, dated 04/23/2003], calculated using FIRST (surface water) and PRZM-GW (groundwater) for use in the human health risk assessment were as shown in Table 1.  A more definitive assessment could be performed, using the Tier II aquatic model PWC and through possible additional refinements.  Should any questions arise, please, contact EFED.

Table 1.  Tier I Estimated Drinking Water Concentrations (EDWCs) for human health drinking water risk assessment application of etoxazole, based on a seasonal application on mint at 0.36 lb a.i./A/season[1] (surface waters) or corn at 0.27 lb a.i./A/season (groundwater)
Chemical[2]
                           Acute EDWC Surface Water
                                FIRST (ppb)[3]
                                 Chronic EDWC
                                 Surface Water
                                FIRST (ppb)[3]
                          Max. Acute EDWC Groundwater
                               PRZM-GW (ppb)[4]
                Max. Chronic EDWC Groundwater  PRZM-GW (ppb)[4]
Etoxazole
                                     6.07
                                     0.618
                                   <0.01
                                   <0.01
R-8
                                     8.03
                                     4.08

R-13
                                     1.63
                                     0.063

[1] For the use on mint (surface water), the current maximum seasonal rate is lower at 0.18 lb a.i./A x 1 application.  Presented results are from a previous DWA in which two applications/season were assessed instead (DP Barcode 352617, dated February 10, 2009).
[2] For structures of these chemicals, see Table 3.
[3] Results presented in ppb of each of the chemicals, as opposed to ppb of parent equivalent.
[4] Groundwater results are for the total toxic residues (parent + R-8 + R-13), expressed in ppb parent equivalent.  For all six standard scenarios, breakthrough was incomplete even after 100-year modeling; therefore, groundwater EDWCs are low compared to surface water EDWCs.

Use Information

There are three products involved in this petition: Etoxazole Technical (EPA Reg. No. 59639-107) and the end-use products Zeal[(R)] WP Miticide (EPA Reg. No. 59639-138, containing 72% A.I.) and Zeal[(R)] SC Miticide (EPA Reg. No. 59639-202, containing 31.7% A.I. or 2.88 lb A.I./gallon).  The proposed new use on sweet corn is for control of species like banks grass mite, Carmine spider mite, Pacific spider mite, spider mites, strawberry spider mite, two-spotted spider mite.  A single application is proposed at a rate ranging from 0.045 to 0.135 lb a.i./A (only one application is allowed per season on sweet corn), applied by ground or aerial methods (except for New York, where aerial applications are not allowed; Table 2).  The current highest exposure scenario is corn, with two applications at 0.135 lb a.i./A and an interval between applications of 14 days.  Groundwater EDWCs were modeled at the corn rate.  However, previous surface water EDWCs were conducted at 0.18 lb a.i./A/application x 2 applications or 0.36 lb a.i./A/season for the use on mint.  Note that the currently approved rate on mint is 0.18 lb a.i./A x one application/ season, although two applications are allowed per year in one of the labels.

Table 2.  Summary use information for the proposed new uses of etoxazole, based on Zeal[(R)] WP Miticide and Zeal[(R)] SC Miticide labels (New crops and/or crop group changes are redlined.)
                                      USE
                               Single App. Rate
                                 (lb. a.i./A)
                       Max. Number of Apps. at Max. Rate
                              Seasonal App. Rate
                                  (lb a.i./A)
                       Min Interval Between Apps (days)
                                  App Method
                                  PHI (days)
Subgroup 8-10B: Pepper/Eggplant: African eggplant, eggplant, pea eggplant, pepino, roselle, scarlet eggplant, bell pepper, martynia, non-bell pepper, okra, cultivars, varieties and/or hybrids of these
                                  0.09-0.135
                                       1
                              0.135; 0.27/year[3]
                                Not applicable
                                    Ground
                                       7
Crop Group 9: Cucurbit Vegetables: Acorn Squash, Balsam Apple, Balsam Pear, Bittermelon, Butternut Squash, Calabaza Squash, Cantaloupe, Chayote (fruit), Chinese, Cucumber, Chinese Okra, Chinese Waxgourd (Chinese Preserving Melon), Citron Melon, Cucumber, Cucuzza, Gherkin, Edible Gourd, Hechima, Hubbard Squash, Hyotan, Momordica spp., Muskmelon, Pumpkin, Spaghetti Squash, Summer Squash, Watermelon, Winter Squash
                                  0.09-0.135
                                       1
                                     0.135
                                Not applicable
                               Ground, aerial[1]
                                       7
Crop Group 11-10: Pome Fruit: Apple; azarole; crabapple; loquat; mayhaw; medlar; pear; Asian pear; quince; Chinese quince; Japanese quince; tejocote; cultivars, varieties, and/or hybrids of these.
                                  0.09-0.135
                                       1
                              0.135; 0.27/year[3]
                                Not applicable
                               Ground (airblast)
                                      14
Crop Group 12-12: Stone Fruit: Apricot; Japanese apricot; capulin; black cherry; Nanking cherry; sweet cherry; tart cherry; Chinese Jujube; nectarine; peach; plum; American plum; beach plum; Canada plum; cherry plum; Chickasaw plum; Damson plum; Japanese plum; Klamath plum; prune plum; plumcot; sloe; cultivars, varieties, and/or hybrids of these.
                                  0.09-0.135
                                       1
                              0.135; 0.27/year[3]
                                Not applicable
                                    Ground
                                       7
Crop Subgroup 13-07A: Caneberry: Blackberry; loganberry; raspberry, black and red; wild raspberry; cultivars, varieties, and/or hybrids of these
                                  0.09-0.135
                                       1
                                     0.135
                                      N/A
                                    Ground
                                       0
Crop Subgroup 13-07F: Small Fruit Vine Climbing, except Fuzzy Kiwifruit: Amur river grape; gooseberry; grape; hardy kiwifruit; maypop; schisandra berry; cultivars, varieties, and/or hybrids of these
                                  0.09-0.135
                                       1
                                     0.135
                                Not applicable
                                    Ground
                                      14
Crop Subgroup 13-07G: Low Growing Berry: Bearberry; bilberry; blueberry, lowbush; cloudberry; cranberry; lingonberry; muntries; partridgeberry; strawberry; cultivars, varieties, and/or hybrids of these
                                  0.09-0.135
                                       1
                                     0.135
                                Not applicable
                                    Ground
                                       1
Crop Group No. 14-12: Tree Nuts: African nut-tree; almond; beechnut; Brazil nut; Brazilian pine; bunya; bur oak; butternut; Cajou nut; candlenut; cashew; chestnut; chinquapin; coconut; coquito nut; dika nut; ginkgo; Guiana chestnut; hazelnut (filbert); heartnut; hickory nut; Japanese horse-chestnut; macadamia nut; mongongo nut; monkey-pot; monkey puzzle nut; Okari nut; Pachira nut; peach palm nut; pecan; pequi; Pili nut; pine nut; pistachio; Sapucaia nut; tropical almond; black walnut; English walnut; yellowhorn; cultivars, varieties, and/or hybrids of these.
                                  0.09-0.135
                                       1
                                     0.135
                                Not applicable
                               Ground (airblast)
                                      28
Crop Group: Tropical and Sub-tropical Fruits (inedible peel): Avocado, papaya, star apple, black sapote, mango, sapodilla, canistel, mamey sapote
                                  0.09-0.135
                                       1
                                     0.135
                                Not applicable
                               Ground, Aerial[1]
                                       1
Corn: Field Corn, Popcorn, Corn (grown for seed production)
                                  0.045-0.135
                                       2
                                     0.27
                                      14
                               Ground, Aerial[1]
                                      21
Sweet Corn
                                  0.045-0.135
                                       1
                                     0.135
                                Not applicable
                               Ground, Aerial[1]
                                      21
Subgroup 20C: Cottonseed: Cottonseed; cultivars, varieties, and/or hybrids of these.
                                  0.03-0.045
                                       1
                                     0.045
                                Not applicable
                                Ground, Aerial
                                      28
Hops
                                  0.135-0.18
                                       1
                                     0.18
                                Not applicable
                                    Ground
                                       7
Mint: Peppermint, Spearmint
                                   0.09-0.18
                                       1
                              0.18; 0.36/year[3]
                                Not applicable
                               Ground, Aerial[1]
                                       7
Soybean
                                  0.045-0.135
                                       1
                                     0.135
                                Not applicable
                               Ground, aerial[1]
                                     NS[2]
Non-bearing fruit trees
                                  0.09-0.135
                                       1
                                     0.135
                                Not applicable
                               Ground (airblast)
                                    1 year
Christmas trees
                                  0.09-0.135
                                       1
                                     0.135
                                Not applicable
                                Ground, Aerial
                                      N/A
[1] Not approved for aerial applications in New York.
[2] NS = not specified.  Do not apply after R5 stage.
[3] For these crops the maximum seasonal and per year application rates as shown.

Identification of specific data gaps:

The environmental fate data base for etoxazole was found to be adequate for a Tier 1 drinking water assessment.  In the Problem Formulation for Registration Review (DP Barcode 418231, dated 07/01/2014), aerobic and anaerobic aquatic metabolism studies were required.

Table 3. Etoxazole and Its Degradates/Residues of Concern
Registrant's Code
                       Chemical's Name and SMILES Code
                                   Structure
Etoxazole
IUPAC Name: (RS)-5-tert-butyl-2-[2-(2,6-difluorophenyl)4,5-dihydro-1,3-oxazole-4-yl] phenetole

CAS Name: 2-(2,6-difluorophenyl)4-[4-(1,1-demethylethyl) 2-ethoxyphenyl-4,5-dihydrooxazole

CAS No.: 153233-91-1

Formula: C21H23F2NO2
MW: 359.4 g/mol

R-8
2-amino-2-(4-tert-butyl-2-ethoxyphenyl)ethanol

SMILES Code: C(C1=C(C=C(C=C1)C(C)(C)C)OCC)(N([H])[H])CO[H]

Formula: C14H23NO2
MW: 237.34 g/mol

R-13
4-(4-tert-Butyl-2-ethoxyphenyl)-2-(2,6-difluorophenyl)-oxazole

SMILES Code: C1(=CC=CC(=C1C2=NC(=CO2)C3=C(C=C(C=C3)C(C)(C)C)OCC)F)F

Formula: C21H21F2NO2
MW: 357.40 g/mol


[Federal Register Volume 77, Number 206 (Wednesday, October 24, 2012)]
[Proposed Rules]
[Pages 64943-64946]
[FR Doc No: 2012-26218]

=======================================================================
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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 165

[Docket Number USCG-2012-0938]
RIN 1625-AA87

Security Zone, Potomac and Anacostia Rivers; Washington, DC

AGENCY: Coast Guard, DHS.

ACTION: Notice of proposed rulemaking.

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

SUMMARY: The Coast Guard proposes to establish a temporary security
zone encompassing certain waters of the Potomac and Anacostia Rivers.
This action is necessary to prevent terrorist acts and incidents and to
safeguard high-ranking government officials and the public-at-large
immediately before, during and after activities associated with the
Presidential Inauguration in Washington, DC from January 15, 2013
through January 24, 2013. This rule prohibits vessels and people from
entering the security zone and requires vessels and persons in the
security zone to depart the security zone, unless specifically exempt
under the provisions in this rule or granted specific permission from
the Coast Guard Captain of the Port Baltimore.

DATES: Comments and related material must be received by the Coast
Guard on or before November 23, 2012.

ADDRESSES: You may submit comments identified by docket number using
any one of the following methods:
    (1) Federal eRulemaking Portal: http://www.regulations.gov.
    (2) Fax:<PHONE_NUMBER>.
    (3) Mail or Delivery: Docket Management Facility (M-30), U.S.
Department of Transportation, West Building Ground Floor, Room W12-140,
1200 New Jersey Avenue SE., Washington, DC 20590-0001. Deliveries
accepted between 9 a.m. and 5 p.m., Monday through Friday, except
federal holidays. The telephone number is<PHONE_NUMBER>.
    See the ``Public Participation and Request for Comments'' portion
of the SUPPLEMENTARY INFORMATION section below for further instructions
on submitting comments. To avoid duplication, please use only one of
these three methods.

FOR FURTHER INFORMATION CONTACT: If you have questions on this rule,
call or email Mr. Ronald L. Houck, Sector Baltimore, Waterways
Management Division, U.S. Coast Guard; telephone<PHONE_NUMBER>, email
<EMAIL_ADDRESS>If you have questions on viewing or submitting
material to the docket, call Renee V. Wright, Program Manager, Docket
Operations, telephone<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Table of Acronyms

DHS Department of Homeland Security
FR Federal Register
NPRM Notice of Proposed Rulemaking

A. Public Participation and Request for Comments

    We encourage you to participate in this rulemaking by submitting
comments and related materials. All comments received will be posted
without change to http://www.regulations.gov and will include any
personal information you have provided.

1. Submitting Comments

    If you submit a comment, please include the docket number for this
rulemaking, indicate the specific section of this document to which
each comment applies, and provide a reason for each suggestion or
recommendation. You may submit your comments and material online at
http://www.regulations.gov, or by fax, mail, or hand delivery, but
please use only one of these means. If you submit a comment online, it
will be considered received by the Coast Guard when you successfully
transmit the comment. If you fax, hand deliver, or mail your comment,
it will be considered as having been received by the Coast Guard when
it is received at the Docket Management Facility. We recommend that you
include your name and a mailing address, an email address, or a
telephone number in the body of your document so that we can contact
you if we have questions regarding your submission.

    To submit your comment online, go to http://www.regulations.gov,
type the docket number [USCG-2012-0938] in the ``SEARCH'' box and click
``SEARCH.'' Click on ``Submit a Comment'' on the line associated with
this rulemaking.
    If you submit your comments by mail or hand delivery, submit them
in an unbound format, no larger than 8\1/2\ by 11 inches, suitable for
copying and electronic filing. If you submit comments by mail and would
like to know that they reached the Facility, please enclose a stamped,
self-addressed postcard or envelope. We will consider all comments and
material received during the comment period and may change the rule
based on your comments.

2. Viewing Comments and Documents

    To view comments, as well as documents mentioned in this preamble
as being available in the docket, go to http://www.regulations.gov,
type the docket number (USCG-2012-0938) in the ``SEARCH'' box and click
``SEARCH.'' Click on Open Docket Folder on the line associated with
this rulemaking. You may also visit the Docket Management Facility in
Room W12-140 on the ground floor of the Department of Transportation
West Building, 1200 New Jersey Avenue SE., Washington, DC 20590,
between 9 a.m. and 5 p.m., Monday through Friday, except Federal
holidays.

3. Privacy Act

    Anyone can search the electronic form of comments received into any
of our dockets by the name of the individual submitting the comment (or
signing the comment, if submitted on behalf of an association,
business, labor union, etc.). You may review a Privacy Act notice
regarding our public dockets in the January 17, 2008, issue of the
Federal Register (73 FR 3316).

4. Public Meeting

    We do not now plan to hold a public meeting. But you may submit a
request for one, using one of the methods specified under ADDRESSES.
Please explain why you believe a public meeting would be beneficial. If
we determine that one would aid this rulemaking, we will hold one at a
time and place announced by a later notice in the Federal Register.

B. Regulatory History and Information

    This rule involves the Presidential Inauguration, an event with a
swearing-in ceremony that takes place in Washington, DC every four
years on January 20th following the U.S. General election in November.
The 55th and 56th Presidential Inaugurations were designated National
Special Security Events by the Department of Homeland Security.

C. Basis and Purpose

    On January 20, 2013, the U.S. Presidential Inauguration swearing-in
ceremony will take place at the U.S. Capitol in Washington, DC.
Activities associated with the Presidential Inauguration include
several Inaugural ceremonies, balls, parades and receptions in the
District of Columbia, which are scheduled to occur from January 15,
2013 through January 24, 2013. During these activities, a gathering of
high-ranking United States officials and the public-at-large is
expected to take place. These activities are located along navigable
waterways within the Captain of the Port Baltimore's Area of
Responsibility. The Coast Guard has given each Coast Guard Captain of
the Port the ability to implement comprehensive port security regimes
designed to safeguard human life, vessels, and waterfront facilities
while still sustaining the flow of commerce.
    The Captain of the Port Baltimore is proposing to establish a
security zone to address the aforementioned security concerns and to
take steps to prevent the catastrophic impact that a terrorist attack
against the large gatherings of high-ranking United States officials,
the public-at-large, and surrounding waterfront areas and communities
would have. The proposed security zone is necessary to safeguard life
and property on the navigable waters before, during, and after
activities associated with the Presidential Inauguration and will help
the Coast Guard prevent vessels or persons from bypassing the security
measures established on shore for the events and engaging in waterborne
terrorist actions during the highly-publicized events.

D. Discussion of Proposed Rule

    Through this regulation, the Coast Guard proposes to establish a
temporary security zone. The proposed zone will be in effect from
January 15, 2013 through January 24, 2013. The proposed zone will cover
(1) all waters of the Potomac River, from shoreline to shoreline,
bounded on the north by the Francis Scott Key (U.S. Route 29) Bridge at
mile 113.0, downstream to and bounded on the south between the Virginia
shoreline and the District of Columbia shoreline along latitude
38[deg]51'00'' N, including the waters of the Georgetown Channel Tidal
Basin; and (2) all waters of the Anacostia River, from shoreline to
shoreline, bounded on the north by the 11th Street (I-295) Bridge at
mile 2.1, downstream to and bounded on the south by its confluence with
the Potomac River.
    This rule requires that entry into or remaining in this security
zone is prohibited unless authorized by the Coast Guard Captain of the
Port Baltimore. Vessels already at berth, mooring, or anchor in the
security zone at the time the security zone is implemented do not have
to depart the zone. All vessels underway within this security zone at
the time it is implemented are to depart the zone. To seek permission
to transit the area of the security zone, the Captain of the Port
Baltimore can be contacted at telephone number<PHONE_NUMBER> or on
Marine Band Radio VHF-FM channel 16 (156.8 MHz). Coast Guard vessels
enforcing the security zone can be contacted on Marine Band Radio VHF-
FM channel 16 (156.8 MHz). Federal, state, and local agencies may
assist the Coast Guard in the enforcement of the security zone. The
Coast Guard will issue notices to the maritime community to further
publicize the security zone and notify the public of changes in the
status of the zone. Such notices will continue until the event is
complete.

E. Regulatory Analyses

    We developed this proposed rule after considering numerous statutes
and executive orders related to rulemaking. Below we summarize our
analyses based on a number of these statutes or executive orders.

1. Regulatory Planning and Review

    This proposed rule is not a significant regulatory action under
section 3(f) of Executive Order 12866, Regulatory Planning and Review,
as supplemented by Executive Order 13563, Improving Regulation and
Regulatory Review, and does not require an assessment of potential
costs and benefits under section 6(a)(3) of Executive Order 12866 or
under section 1 of Executive Order 13563. The Office of Management and
Budget has not reviewed it under those Orders. There is no vessel
traffic associated with recreational boating and commercial fishing
expected during the effective period, and vessels may seek permission
from the Captain of the Port Baltimore to enter and transit the zone.

2. Impact on Small Entities

    Under the Regulatory Flexibility Act (5 U.S.C. 601-612), we have
considered the impact of this proposed rule on small entities. The
Coast Guard certifies under 5 U.S.C. 605(b) that this proposed rule
will not have a significant economic impact on a substantial

number of small entities. This proposed rule would affect the following
entities, some of which might be small entities: the owners or
operators of vessels intending to operate or transit through or within
the security zone during the enforcement period. Although the security
zone will apply to the entire width of the Potomac and Anacostia
Rivers, traffic may be allowed to pass through the zone with the
permission of the Captain of the Port Baltimore. Before the effective
period, maritime advisories will be widely available to the maritime
community. Additionally, given the time of year this event is
scheduled, the vessel traffic is expected to be minimal.
    If you think that your business, organization, or governmental
jurisdiction qualifies as a small entity and that this rule would have
a significant economic impact on it, please submit a comment (see
ADDRESSES) explaining why you think it qualifies and how and to what
degree this rule would economically affect it.

3. Assistance for Small Entities

    Under section 213(a) of the Small Business Regulatory Enforcement
Fairness Act of 1996 (Pub. L. 104-121), we want to assist small
entities in understanding this proposed rule. If the rule would affect
your small business, organization, or governmental jurisdiction and you
have questions concerning its provisions or options for compliance,
please contact the person listed in the FOR FURTHER INFORMATION
CONTACT, above. The Coast Guard will not retaliate against small
entities that question or complain about this proposed rule or any
policy or action of the Coast Guard.

4. Collection of Information

    This proposed rule will not call for a new collection of
information under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-
3520.).

5. Federalism

    A rule has implications for federalism under Executive Order 13132,
Federalism, if it has a substantial direct effect on the States, on the
relationship between the national government and the States, or on the
distribution of power and responsibilities among the various levels of
government. We have analyzed this proposed rule under that Order and
determined that this rule does not have implications for federalism.

6. Protest Activities

    The Coast Guard respects the First Amendment rights of protesters.
Protesters are asked to contact the person listed in the FOR FURTHER
INFORMATION CONTACT section to coordinate protest activities so that
your message can be received without jeopardizing the safety or
security of people, places or vessels.

7. Unfunded Mandates Reform Act

    The Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1531-1538)
requires Federal agencies to assess the effects of their discretionary
regulatory actions. In particular, the Act addresses actions that may
result in the expenditure by a State, local, or tribal government, in
the aggregate, or by the private sector of $100,000,000 (adjusted for
inflation) or more in any one year. Though this proposed rule would not
result in such an expenditure, we do discuss the effects of this rule
elsewhere in this preamble.

8. Taking of Private Property

    This proposed rule would not cause a taking of private property or
otherwise have taking implications under Executive Order 12630,
Governmental Actions and Interference with Constitutionally Protected
Property Rights.

9. Civil Justice Reform

    This proposed rule meets applicable standards in sections 3(a) and
3(b)(2) of Executive Order 12988, Civil Justice Reform, to minimize
litigation, eliminate ambiguity, and reduce burden.

10. Protection of Children From Environmental Health Risks

    We have analyzed this proposed rule under Executive Order 13045,
Protection of Children from Environmental Health Risks and Safety
Risks. This rule is not an economically significant rule and would not
create an environmental risk to health or risk to safety that might
disproportionately affect children.

11. Indian Tribal Governments

    This proposed rule does not have tribal implications under
Executive Order 13175, Consultation and Coordination with Indian Tribal
Governments, because it would not have a substantial direct effect on
one or more Indian tribes, on the relationship between the Federal
Government and Indian tribes, or on the distribution of power and
responsibilities between the Federal Government and Indian tribes.

12. Energy Effects

    This proposed rule is not a ``significant energy action'' under
Executive Order 13211, Actions Concerning Regulations That
Significantly Affect Energy Supply, Distribution, or Use.

13. Technical Standards

    This proposed rule does not use technical standards. Therefore, we
did not consider the use of voluntary consensus standards.

14. Environment

    We have analyzed this proposed rule under Department of Homeland
Security Management Directive 023-01 and Commandant Instruction
M16475.lD, which guide the Coast Guard in complying with the National
Environmental Policy Act of 1969 (NEPA) (42 U.S.C. 4321-4370f), and
have made a preliminary determination that this action is one of a
category of actions that do not individually or cumulatively have a
significant effect on the human environment. This proposed rule
involves establishing a temporary security zone. This rule is
categorically excluded from further review under paragraph 34(g) of
Figure 2-1 of the Commandant Instruction. A preliminary environmental
analysis checklist supporting this determination and a Categorical
Exclusion Determination are available in the docket where indicated
under ADDRESSES. We seek any comments or information that may lead to
the discovery of a significant environmental impact from this proposed
rule.

List of Subjects in 33 CFR Part 165

    Harbors, Marine safety, Navigation (water), Reporting and
recordkeeping requirements, Security measures, Waterways.

    For the reasons discussed in the preamble, the Coast Guard proposes
to amend 33 CFR part 165 as follows:

PART 165--REGULATED NAVIGATION AREAS AND LIMITED ACCESS AREAS

    1. The authority citation for part 165 continues to read as
follows:

    Authority:  33 U.S.C. 1231; 46 U.S.C. Chapter 701, 3306, 3703;
50 U.S.C. 191, 195; 33 CFR 1.05-1, 6.04-1, 6.04-6, and 160.5; Pub.
L. 107-295, 116 Stat. 2064; Department of Homeland Security
Delegation No. 0170.1.

    2. Add Sec.  165.T05-0938 to read as follows:

Sec.  165.T05-0938  Security Zone, Potomac and Anacostia Rivers;
Washington, DC.

    (a) Location. The following area is a security zone: (1) all waters
of the Potomac River, from shoreline to shoreline, bounded on the north
by the Francis Scott Key (U.S. Route 29) Bridge at mile 113.0,
downstream to and

bounded on the south between the Virginia shoreline and the District of
Columbia shoreline along latitude 38[deg]51'00'' N, including the
waters of the Georgetown Channel Tidal Basin; and (2) all waters of the
Anacostia River, from shoreline to shoreline, bounded on the north by
the 11th Street (I-295) Bridge at mile 2.1, downstream to and bounded
on the south by its confluence with the Potomac River. All coordinates
refer to datum NAD 1983.
    (b) Regulations. The general security zone regulations found in 33
CFR 165.33 apply to the security zone created by this temporary
section, Sec.  165.T05-0938.
    (1) All persons are required to comply with the general regulations
governing security zones found in 33 CFR 165.33.
    (2) Entry into or remaining in this zone is prohibited unless
authorized by the Coast Guard Captain of the Port Baltimore. Vessels
already at berth, mooring, or anchor at the time the security zone is
implemented do not have to depart the security zone. All vessels
underway within this security zone at the time it is implemented are to
depart the zone.
    (3) Persons desiring to transit the area of the security zone must
first obtain authorization from the Captain of the Port Baltimore or
his designated representative. Permission may be requested prior to
activation of the zone. To seek permission to transit the area, the
Captain of the Port Baltimore and his designated representatives can be
contacted at telephone number<PHONE_NUMBER> or on Marine Band Radio VHF-
FM channel 16 (156.8 MHz). The Coast Guard vessels enforcing this
section can be contacted on Marine Band Radio VHF-FM channel 16 (156.8
MHz). Upon being hailed by a U.S. Coast Guard vessel, or other Federal,
State, or local agency vessel, by siren, radio, flashing light, or
other means, the operator of a vessel shall proceed as directed. If
permission is granted, all persons and vessels must comply with the
instructions of the Captain of the Port Baltimore or his designated
representative and proceed at the minimum speed necessary to maintain a
safe course while within the zone.
    (4) Enforcement. The U.S. Coast Guard may be assisted in the patrol
and enforcement of the zone by Federal, State, and local agencies.
    (c) Definitions. As used in this section:
    Captain of the Port Baltimore means the Commander, U.S. Coast Guard
Sector Baltimore, Maryland.
    Designated representative means any Coast Guard commissioned,
warrant, or petty officer who has been authorized by the Captain of the
Port Baltimore to assist in enforcing the security zone described in
paragraph (a) of this section.
    (d) Effective period. This section will be enforced from 8 a.m. on
January 15, 2013 through 10 p.m. on January 24, 2013.

    Dated: October 10, 2012.
Kevin C. Kiefer,
Captain, U.S. Coast Guard, Captain of the Port Baltimore.
[FR Doc. 2012-26218 Filed 10-23-12; 8:45 am]
BILLING CODE 9110-04-P


EPA REGISTRATION DIVISION COMPANY NOTICE OF FILING FOR PESTICIDE PETITIONS PUBLISHED IN THE FEDERAL REGISTER

EPA Registration Division contact: [P. V. Shah,<PHONE_NUMBER>]

INSTRUCTIONS:  Please utilize this outline in preparing the pesticide petition.  In cases where the outline element does not apply, please insert "NA-Remove" and maintain the outline. Please do not change the margins, font, or format in your pesticide petition. Simply replace the instructions that appear in green, i.e., "[insert company name]," with the information specific to your action.

PP IN-10720. (EPA - HQ - OPP - 2014-0633). The firm Lewis and Harrison, 122 C Street NW., Suite 505, Washington, DC 20001 one behalf of the BASF Corporation 100 Park Ave., Florham Park, NJ 07932 requests to establish an exemption from the requirement of a tolerance for residues of methane sulfonic acid  (CAS No. 75-75-2) when used as a pesticide inert ingredient in pesticide formulations under §180.930 and §180.940(a)  when used as a acid cleaner in pesticide formulations with a limit of 3% when used on animals; and 15% (5,000 ppm in use-dilution solution) when used in antimicrobial formulations for food-contact surface sanitizing in public eating places, dairy-processing equipment, and food-processing equipment and utensils. The petitioner believes no analytical method is needed because  residue data, including an analytical method, is not pertinent or required for this petition since an exemption from tolerance is requested.
  Contact: Registration Division/OPP.
EPA has determined that the petition contains data or information regarding the elements set forth in section 408 (d)(2) of FDDCA; 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.

   Residue Chemistry

Residue data, including an analytical method, is not pertinent or required for this petition since an exemption from tolerance is requested.

   Toxicological Profile

An extensive safety data base has been complied on Methanesulfonic Acid (MSA). The safety data base includes acute, subchronic, developmental toxicity, and mutagenicity studies. Data have been submitted as part of the High Production Volume program in EPA's Office of Pollution Prevention and Toxics. Those data are summarized below.

        1. Acute toxicity

MSA is of low toxicity via the oral, dermal, and inhalation routes. At high concentrations, MSA can be severely irritating and corrosive to eyes and skin. MSA is not a dermal sensitizer.

              a. Acute oral toxicity

The acute oral toxicity of MSA ranges from 649 mg/kg (>750 mg/kg ♂; 461 mg/kg ♀) for anhydrous acid to 1,157.5 mg/kg (860.1 mg/kg ♂; 2,407.6 mg/kg ♀) for a 70% solution. >5,000 mg/kg.

                     i. Acute oral toxicity in Sprague Dawley rats: Anhydrous MSA

Groups of five rats/sex were exposed by oral gavage to 300, 500 and 750 mg/kg bw anhydrous (99.6% pure) MSA (Elf Atochem, 1988). Clinical signs included salivation, decreased activity, wobbly gait, breathing abnormalities, apparent hypothermia, decreased/no defecation, feces small in size, urine stain, hunched posture, unkempt appearance, rough haircoat, piloerection, extremities pale in color, de hydration, emaciation, distended abdomen, decreased food consumption and dark material around the facial area. Body weight loss was noted for one male at 300 mg/kg bw, two females and one male at 500 mg/kg bw, and one male at 750 mg/kg bw during the study day 0-7. Body weight loss was noted for one male each at 300 mg/kg bw and 750 mg/kg bw during the study day 7-14. Body weight gain was noted for all other surviving animals during the test period. Gross pathology findings observed in the animals that died included distension/abnormal content/reddened mucosa in the digestive tract, dark red/mottled lungs, blackish-purple spleens, dark red lymph nodes, stained glandular mucosa in the stomach and body fat depletion/discoloration/adhesions in the abdominal cavity. Necropsy findings on study day 14 for the animals that survived included abnormal content in the digestive tract and thickened mucosa in the stomach. The acute oral LD50 of anhydrous MSA in the male rat was greater than 750 mg/kg bw and 461 mg/kg bw in the female rat, and 649 mg/kg bw in the sexes combined.

				 ii. Acute oral toxicity in Sprague Dawley rats: 70% MSA

Groups of five rats/sex were exposed by oral gavage to 500, 1000, and 1500 mg/kg bw 70% MSA in water (Elf Atochem, 1997a). Clinical signs included salivation, breathing abnormalities, wobbly gait, decreased activity, decreased defecation, rough haircoat, urine/fecal stain and dark material around the facial area. Body weight loss was noted for two animals at 1000 mg/kg bw during the study day 0-7 and for one animals each at 300 mg/kg bw 1000 mg/kg bw during the study day 7-14. Body weight gain was noted for all other surviving animals during the test period. Gross internal findings were observed only in the animals that died and included abnormal content and reddened/thickened mucosa and discoloration in the digestive tract, dark red foci on the liver and blackish-purple spleens. The acute oral LD50 of 70% MSA in the male rat was 860 mg/kg bw, 2408 mg/kg bw in the female rat, and 1158 mg/kg bw in the sexes combined.

			 iii. Acute oral toxicity in Wistar rats: 98% MSA

Five male rats were exposed by oral gavage to anhydrous MSA (98% pure) at 0.25, 0.5 ml/kg bw. Three rats were exposed at 1.0 ml/kg bw (Union Carbide, 1975). At all dose levels, rats were sluggish and presented an unsteady gait. In addition, at 1.0 ml/kg bw, deep breathing was immediately observed. At 0.25 ml/kg bw, 2/5 rats died. At 0.5 ml/kg bw 5/5 rats died; and at 1.0 ml/kg bw 2/3 rats died. Necropsy findings included livers mottled and burned, stomach burned, pylorus hemorrhaged and gas filled, intestines hemorrhaged, injected and gas filled, kidneys mottled and slightly congested. The LD50 was 0.28 ml/kg bw.

 Acute dermal toxicity.

The acute dermal toxicity of MSA ranges from greater than 200 to less than 2,000 mg/kg bw.

			i.  Acute dermal toxicity in New Zealand White rabbits: 70% MSA

In an OECD 402 test, one male New Zealand White rabbit was dosed dermally at 1000 mg/kg bw of 70% MSA in water (Atofina, 2002). Since no irritation was noted, an additional nine animals (4 males and 5 females) were dosed. The test article was kept in contact with the skin for 24 hours. Animals were observed for mortality, toxicity and pharmacological effects, body weights recorded and animals were examined for gross pathology. Dermal responses were recorded 24 hours post-dosing and on days 7 and 14. All animals survived the treatment. Instances of few feces were the only abnormal signs noted during the observation period. Dermal responses were slight to well-defined on day 1, absent to severe on day 7 and absent to slight on day 14. Body weight changes and necropsy results were normal. The LD50 was greater than 1000 mg/kg bw.

			 ii. Acute dermal toxicity in albino rabbits: Anhydrous MSD

Six albino rabbits were exposed to 200 and 2000 mg/kg bw anhydrous MSA (purity not specified) under occlusive cover for 24 hours (Pennwalt, 1978). Skin contact with 2000 mg/kg bw caused intense and prolonged pain. The skin was dark grey in appearance and scattered  portions were separating from the subcutaneous tissues. Two rabbits died and 1 rabbit was euthanized. There were no mortalities at 200 mg/kg bw. Erythema was present over the entire trunk of each animal together with numerous small lesions. There were no clinical signs and animals gained weight during the 7-day observation period. The LD50 was greater than 200 and less than 2000 mg/kg bw.

 Acute inhalation toxicity.

No mortalities have been noted in several tests conducted with rats and mice. Insufficient volatility of methane sulfonic acid limits the actual exposure and therefore toxicity risks.

 Acute inhalation toxicity in mice: 99% MSA

In testing using 99% MSA, 20 mice were exposed to whole body atmospheric. No effects of any kind were discernible in any of the 20 mice either during or after exposure for 1 hour to saturated vapor (at 20°C). All showed normal gains in body weight during the subsequent 7 -day observation period.

 Acute eye irritation.

At high concentrations, MSA can be severely irritating and corrosive to eyes.

 Acute eye irritation in albino rabbits: 99% MSA

In acute eye irritation testing using rabbits, 0.1 mL of 99% MSA was instilled in the eyes of two animals in a single administration. One of the two animals had a rinse of the treated eye with flowing water (initiated 20 to 30 seconds after instillation and continued for one minute).  Animals were observed at 10 minutes; 1, 2, 3, 4, 24, 48, and 72 hours; and 4, 5, 6, and 7 days post-treatment.

Each instillation caused excruciating pain. In the unwashed eye, the reaction involved all ocular tissues and occurred immediately; the conjunctivae became completely necrotic (white) without evident swelling; the iris was dilated with ragged edges and failed to
react to light; and the cornea opacified completely within 24 hours. In the washed eye, the reaction did not differ significantly from that of unwashed eye.

Under the conditions of this test, MSA is extremely corrosive to eye.

              e. Acute skin irritation.

At high concentrations, MSA can be severely irritating and corrosive to skin.

                     i. Acute skin irritation in albino rabbits: 99% MSA

In acute skin irritation testing with albino rabbits, six animals were dosed with either 200 or 2,000 mg/kg of 99% MSA utilizing a pre-fitted impervious sleeve for 24 hours. At the conclusion of the exposure period, the test substance was removed with a saturated solution of sodium bicarbonate and the animals were observed for a period of seven days.

For animals treated with 2,000 mg/kg, skin contact caused intense and prolonged pain. At the end of exposure, the skin of each animal was dark gray in appearance and scattered portions were separating from the subcutaneous tissues. Two rabbits died the following night (28 hours after initial contact) and one rabbit was euthanized three days after treatment for humane reasons.

At 200 mg/kg, no mortality was seen in any test animals. Erythema (score 2) was present over the entire trunk of each animal together with numerous small lesions which resembled acid burns. Animals nevertheless remained asymptomatic and gained body weight during the observation period.

Under the conditions of this test, dermal exposure to 99% MSA at 2,000 mg/kg is highly toxic (severe skin injuries causing death), whereas 200 mg/kg exposure induces minor skin lesions (erythema and acid burns) but no systemic toxicity.

				 ii. Acute skin irritation in mice: 99% MSA

In acute skin irritation testing with mice, the tails of four anesthetized mice were immersed in 99% MSA to a depth of 4 cm. One hour later the tissue reaction was terminated by plunging the appendages into a saturated solution of sodium bicarbonate for a period of 30 seconds. The tail of each mouse was white when exposure was terminated and the appendage fell off in a day or two.
Under the conditions of this test, 99% MSA is corrosive to mouse skin.

              f. Skin sensitization

MSA is not a dermal sensitizer.

                     i. Skin sensitization in Hartley guinea pig: 70% MSA

In sensitization testing using the Buehler method in Hartley guinea pigs, 20 animals per dose were exposed to the test substance for both the induction and challenge test. A control group of five males and five females was similarly dosed with water. The induction consisted of a 50% occlusive epicutaneous dose, while the challenge was a 25 % occlusive epicutaneous dose. There were three 6-hour applications in 14 days followed by the challenge exposure over 24 hours.

The induction schedule consisted of the following:

 On day 1, dermal application with 0.3 mL of test substance (treated group) or with the vehicle (control group) on the left shoulder.
 On day 7, the same region received another topical application
 On day 14, this same site was treated by a last topical application All these applications lasted approximately 6 hours.

For the challenge dose, on day 28, all the animals received 0.3 ml of the test substance at the concentration of 25% in their right flank. The challenge exposure duration was 24 hours. There was no rechallenge and no positive control.

Animals were examined 24 hours after each induction and the challenge application.

A preliminary study was conducted in order to determine the concentrations to be tested in the main study. The irritation potential of 70% MSA at levels of undiluted, 50%, 25%, 10%, 5%, 2.5%, 1% and 0.5% was evaluated in two groups of four animals each. Four levels of test material were evaluated per animals. Dilutions were obtained with distilled water (w/v). Each application consisted of 0.3 mL of different solutions applied into a 25 mm Hill Top Chamber, which was placed on animals clipped back for 6 hours. The day after, animals were depilated and two hours later, examined for irritation. Another score was performed 40 hours after exposure.

RESULTS OF PILOT STUDY: Undiluted 70% MSA produced grades of 2, 1 and +-, with edema, blanching and scabbing on two sites. Testing at 50%, 25%, 10%, 5%, 2.5% and 1% produced grades of +-, while 0.5% produced grades of +- and 0. Consequently, the 50% concentration was chosen for use at induction for the test group, since it caused no greater than mild to moderate primary irritation. Moreover, the 25% concentration was selected for challenge, because it caused no more than slight irritation.

RESULTS OF DEFINITIVE TEST: None of the test animals responded with a skin grade that would have been suggestive of sensitization.
Under the conditions of this test, MSA is not a sensitizer.

 Genotoxicity

No evidence of genotoxicity or chromosomal effects was observed in mutagenicity studies conducted with MSA.

 Reverse Mutation: 98.8% MSA (anhydrous) and 70% MSA

Bacterial reverse mutation assays (OECD 471) were conducted with anhydrous MSA (98.8% pure) (SNEAP, 1990) and 70% in water (Pennwalt, 1989a). No genotoxicity was observed on Salmonella typhimurium tester strains TA1535, TA1537, TA1538, TA98 and TA100 up to the cytotoxicity threshold of 5000 μg/plate in the presence and absence of metabolic activation.

 Chromosomal Aberration: 70% MSA

Groups of five mice/sex were given a single dose of MSA (70% in water) by oral gavage at 20, 100 or 500 mg/kg bw (Pennwalt, 1989b). Concurrent vehicle and positive control group of mice were similarly dosed with distilled water or chlorambucil, respectively. The test method was comparable to OECD 474. There was no evidence of induced chromosomal or other damage leading to micronucleus formation in polychromatic erythrocytes of treated mice 24, 48 or 72 hours after oral administration.

 Reproductive and developmental toxicity.

No reproductive or developmental effects were noted in any of the tests conducted.

 Reproductive toxicity.

In an OECD 421 study, groups of 12 rats/sex were exposed to MSA (70.5% in water) by oral gavage at doses of 250, 500 and 1000 mg/kg bw/day (Arkema and Chevron Phillips, 2005). Males were exposed 4 weeks before mating, during the mating period (2 weeks) and until sacrifice. Females were exposed 4 weeks before mating, during the mating period (2 weeks), pregnancy (3 weeks), lactation until day 4 postpartum (pp) inclusive, and until sacrifice (day 5 pp). One male animal died at 1000 mg/kg bw/day on day 33 and one female given 250 mg/kg bw/day was found dead on day 10 post-coitum. There were no test article related clinical signs of toxicity. There were no effects on body weights or food consumption. There were no effects on mating index, pre-coital interval, fertility index, duration of gestation, delivery data or postnatal and neonatal losses. There were no effects on the mean number of liveborn pups per litter. Minor differences, considered to be of no toxicological significance, were observed in the weights of testes and epididymides between treated and control males. Macroscopic post-mortem examination revealed no treatment-related effects. No microscopic treatment-related changes were observed for testicular staging or for the ovaries, including semi-quantitative evaluation of the morphological characteristics of ovarian physiology. The no observed effect level (NOEL) for parental toxicity and for toxic effect on reproductive performance and on progeny is 1000 mg/kg bw/day.

 Developmental toxicity.

                     i. OECD 414 Oral rangefinding study in female rats: 70.15% MSA

A range finding study was conducted according to OECD 414 (Elf Atochem, 1996d). Groups of 8 female rats were exposed by oral gavage to doses of MSA (70.15% in water) of 0 (control), 25, 50, 100, 200 and 300 mg/kg bw/d on gestation days 5-15. Treatment-related clinical signs observed consisted of rales, labored respiration and gasping in the 100, 200 and 300 mg/kg bw/d groups. Findings of red material around the nose and/or mouth in the 100, 200 and 300 mg/kg/d groups often correlated with occurrences of the aforementioned respiratory abnormalities. These findings appeared to be a function of the dosage concentration; rather the dosage level, as they were observed with similar frequency in the 100, 200 and 300 mg/kg/d groups, each of which received the test article at a concentration of 50 mg/ml. There were no deaths. Slight mean body weight losses and reduction in food consumption occurred in the 100, 200 and 300 mg/kg bw/day groups during gestation days 6-9 when evaluated on a group mean basis. However, several animals in these groups experienced large, transient body weight losses and corresponding large decreases in food consumption on one or more occasions during the first days of the dosing period. Mean body weights, gravid uterine weights, net body weights and net body weight gains were unaffected by treatment at all dose levels. No treatment related internal necropsy findings were observed at any dose level. And no effects were observed at any dose level on intrauterine growth and survival. No external developmental variations of malformations were observed in any of the foetuses in the treated groups.

                    	 ii. OECD 414 Oral definitive study in female rats: 70.15% MSA

In an OECD 414 study, groups of 25 female rats were exposed to MSA (70.15% in water) by oral gavage at doses of 0 (control), 25, 100 and 400 mg/kg bw from gestation day 6 through 15 (Elf Atochem, 1996c). There were no test article related clinical signs and no deaths. There were no effects on body weight or food consumption. At necropsy, intrauterine growth and survival were unaffected by test article administration at all dose levels. There were no test article related fetal malformations or developmental variations. A dose level of 400 mg/kg bw/day was considered to be the no observable adverse effect level (NOAEL) for maternal toxicity and developmental toxicity.

			 iii. OECD 421 Oral study in rats: 70.5% MSA

In an OECD 421 study, groups of 12 rats/sex were exposed to MSA (70.5% in water) by oral gavage at doses of 250, 500 and 1000 mg/kg bw/day (Arkema and Chevron Phillips, 2005). Males were exposed 4 weeks before mating, during the mating period (2 weeks) and until sacrifice. Females were exposed 4 weeks before mating, during the mating period (2 weeks), pregnancy (3 weeks), lactation until day 4 postpartum (pp) inclusive, and until sacrifice (day 5 pp). There were no effects on postnatal and neonatal losses; the mean number of liveborn pups per litter; pup mortality or clinical signs; pup body weight; or pup sex ratio. The NOEL for developmental effects was 1000 mg/kg bw/day.

 Subchronic toxicity

 Subchronic oral toxicity.

 7-day dietary exposure in rats: 98% MSA (anhydrous)

Five rats/sex were exposed to concentrations of MSA (98% anhydrous) in the diet of 0.043%, 0.159%, 0.382% and 1.635% (males) and 0.045%, 0.183%, 0.479% and 1.80% (females) for seven days (Union Carbide Corporation, 1975). These concentrations were equivalent to 0, 51, 185, 420, 1805 mg/kg bw/d (males) and 0, 55, 201, 551, 2122 mg/kg bw/d (females). There were no deaths, no effects on body weights or organ weights. The NOAEL was 1805 mg/kg/day for males and 2122 mg/kg/day for females.

 Subchronic dermal toxicity.

There are no available subchronic dermal toxicity studies for MSA.

 Subchronic inhalation toxicity.

 5-day nose-only inhalation in rats: 69.9% MSA

Five rats/sex were exposed by nose-only inhalation to MSA (69.9% aqueous solution) at concentrations of 0 (control) 0.026, 0.082, 0.23 and 0.74 mg/L for 6 hours/day for 5 days (Elf Atochem, 1996a). There were 2 and 3 deaths in the 0.23 and 0.74 mg/L groups, respectively. Rales were the only clinical sign observed in the 0.23 and 0.74 mg/L groups. Mean body weights and food consumption were generally reduced in males and females in the 0.74 mg/L group throughout the study. There were no effects on organ weights and no gross findings at necropsy. Microscopic findings in the nasal cavities included mucosal necrosis, suppurative inflammation and/or nasal exudate in males and females in the 0.23 and 0.74 mg/L groups. The NOEL for systemic toxicity was found to be 0.082 mg/L.

			 ii. 28-day nose-only inhalation in rats: 69.9% MSA

Fifteen rats/sex were exposed by nose-only inhalation to MSA (69.9% aqueous solution) at concentrations of 0 (control) 0.026, 0.073 and 0.242 mg/L for 6 hours/day for 5 days/week for four weeks (Elf Atochem, 1996b). There was a two-week recovery period following the 4-week exposure period. During the exposure phase of the study, 4, 1, 1 and 5 animals in the control, low-, mid- and high-exposure groups, respectively, were found dead. These deaths were not considered test article related. Clinical signs were reported only during the exposure period and consisted of rales and an increased incidence of yellow matting on various body surfaces in the high-exposure group animals. Matting was also observed in the mid -exposure group males. A transient reduction in mean body weight gain during the first week of exposure and slightly decreased food consumption throughout the exposure period were noted for the high-exposure group males. There were no effects on hematology, urinalysis, or organ weights. There was a statistically significant increase in blood urea nitrogen and aspartate aminotransferase in the high-exposure group males and females, respectively, at the study week 4 evaluations, but returned to levels comparable to the control group after the two-week recovery period. There were no test article related gross findings in the animals that were found dead during the study and no gross findings in animals at the end of the study. Test article-related microscopic findings were observed in the nasal turbinates of the high-exposure group rats that were found dead and in all treated groups at the study week 4 and 6 evaluations. The severity of some of the findings observed after the two-week recovery period suggested at least partial recovery from the irritative effects of the test article. Based on the compound-induced lesions observed in the nasal turbinates, the no observed effect level (NOEL) for local irritation was considered to be less than 0.026 mg/L. The NOEL for systemic toxicity was considered to be 0.026 mg/L.

 Chronic toxicity.

There are no chronic/oncogencity studies available on MSA. However, chronic studies should not be required for MSA since MSA is not a mutagen, reproductive toxin or endocrine disruptor. There is nothing to indicate that MSA will have any adverse chronic effects on humans or the environment.

 Animal metabolism.

There are no animal metabolism data available on MSA. However, animal metabolism data should not be required for MSA since MSA is not a mutagen, reproductive toxin or endocrine disruptor. There is nothing to indicate that MSA will have any adverse chronic effects on humans or the environment.

 Metabolite toxicology.

There are no metabolites of toxicological concern.

 Endocrine disruption.

There is no information or evidence to indicate that MSA is an endocrine disruptor.

  C. Aggregate Exposure

     1. Dietary exposure.

Dietary (food and drinking water) and residential (dermal and inhalation) exposures are possible from the use of MSA as an inert ingredient in antimicrobial formulations. MSA has been demonstrated to be readily biodegradable, which reduces the likelihood of residues on food. For the same reason, no significant contributions to drinking water are expected from the use of MSA as inert ingredients in pesticide products. MSA has low toxicity and exposure to residues above toxicity levels of concern are not anticipated.

A quantitative dietary risk assessment for the MSA is not necessary since there are no toxicity endpoints of concern that are associated with dietary ingestion of the MSA. Nonetheless, a quantitative risk assessment has been conducted using the systemtic NOEL from the reproduction study.  Specifically, a Reference Dose (RfD) of 10 mg/kg/day was calculated based on a NOEL of 1,000 mg/kg/day in the OECD 421 study in rats using a 10x uncertainty factor for inter- and intra-species extrapolation. The chronic Population Adjusted Dose (cPAD) is also 10 mg/kg/day. No additional uncertainty factor was added to the cPAD calculation as the reproductive and developmental toxicity studies do not indicate any additional susceptibility for infants and children.

The chronic dietary exposure due to MSA use as an inert ingredient in disinfectants (sanitizer) used on food-contact surfaces was assessed. This assessment calculated the Daily Dietary Dose (DDD) and the Estimated Daily Intake (EDI). The assessment considered: application rates, residual solution or quantity of solution remaining on the treated surface without rinsing with potable water, surface area of the treated surface which comes into contact with food, pesticide migration fraction, and body weight. These assumptions are based on FDA guidelines (FDA, 2003).

The EDI calculations presented in this assessment assume that food can contact either 2,000 cm[2] or 4,000 cm[2] (50% and 100% of the FDA worst-case scenario) of treated surfaces, and that 10% of the material would migrate to food. The 10% migration rate is based on Agency Residential Standard Operation Procedures. These daily estimates were conservatively used to assess chronic dietary risks (i.e., percent chronic population adjusted dose or %cPAD).

Assuming a level of 5,000 ppm of MSA in the use dilution solution, the following EDI is calculated:

  EDI: 100% FDA Worst Case

  EDI = 1 mg/solution  x  5,000 ug  x  4,000 cm[2]  x 10%  =  2,000 ug/person/day
                      cm2              1,000 mg     person/day                                   OR
  								   2.0 mg/person/day

  EDI: 50% FDA Worst Case

  EDI = 1 mg/solution  x  5,000 ug  x  2,000 cm[2]  x 10%  =  1,000 ug/person/day
                      cm2              1,000 mg     person/day                                   OR
  								   1.0 mg/person/day

The above calculation is for use of the substance in products that are used in public-eating facilities, which is worst-case. Use in food-processing plants would yield dramatically lower exposures.

Assuming body weights for men (70 kg), women (60 kg), and infants and children (15 kg), the following percent DDD values are calculated:

  DDD: 100% FDA Worst Case

 Male:   	 	2.0 mg/person/day / 70 kg/person = 0.029 mg/kg/day
 Female: 	 	2.0 mg/person/day / 60 kg/person = 0.033 mg/kg/day
 Infants/Children: 	2.0 mg/person/day / 15 kg/person = 0.13 mg/kg/day
  DDD: 50% FDA Worst Case

 Male:   	 	1.0 mg/person/day / 70 kg/person = 0.014 mg/kg/day
 Female: 	 	1.0 mg/person/day / 60 kg/person = 0.017 mg/kg/day
 Infants/Children: 	1.0 mg/person/day / 15 kg/person = 0.067 mg/kg/day

Based on the calculated DDDs and the cPAD value of 10 mg/kg/day, the following percent cPAD estimates are derived:

  % cPAD: 100% FDA Worst Case

 Male:   	 	0.029 mg/kg/day / 10 mg/kg/day = 0.29% cPAD
 Female: 	 	0.033 mg/kg/day / 10 mg/kg/day = 0.33% cPAD
 Infants/Children: 	0.13 mg/kg/day / 10 mg/kg/day = 1.3% cPAD

  % cPAD: 50% FDA Worst Case

 Male:   	 	0.014 mg/kg/day / 10 mg/kg/day = 0.14% cPad
 Female: 	 	0.017 mg/kg/day / 10 mg/kg/day = 0.17% cPad
 Infants/Children: 	0.067 mg/kg/day / 10 mg/kg/day = 0.67% cPad

MSA may contain the impurity, methyl methane sulfonate (MMS), which is of toxicological concern.  BASF has measured levels of 480 and 530 ppb in separate batches of 70% MSA, resulting in a mean value of 505 ppb.  Corrected for purity, this value is estimated at 721.4 ppb.  Because MMS is a known mutagen and a potential carcinogen we need to estimate the upper bound cancer risk from this dietary exposure.  FDA regulations state that a substance with a TD50 of 6.25 mg/kg bw/day will result in a one in a million risk level with a dietary exposure of 1.5 ug/person/day[1].  Based on this benchmark, we can use the lowest statistically significant TD50 for MMS of 31.6 mg/kg bw/day[2] to estimate the upper bound cancer risk from MMS exposure resulting from the use of MSA as an acid excipient in a sanitizing solution at a level of 1,000 ppm for the most vulnerable population, infants and children:

[1.] 21 CFR 170.39. We have used an FDA benchmark to simplify calculations.  EPA risk estimates would not be significantly different.
[2.] Gold, L.S., T.H. Slone, N.B. Manley, G.B. Garfinkel, L. Rohrbach and B.N. Ames (1997).  Carcinogenic Potency Database, Handbook of Carcinogenic Potency and Genotoxicity Databases (L.S. Gold & E. Zeiger, eds.) 1-605.
0.13 mg/kg bw/day x 721.4 ppb MMS in MSA = 9.38 x 10[-8] mg/kg bw/day MMS exposure

9.38 X 10[-8] mg/kg bw/day  x 15 kg bw/person  x           1.0 x 10[-6]  x            6.25 mg/kg bw/day  = 1.9 x 10[-10]
                                                                                0.0015 mg/person/day     31.6 mg/kg bw/day

The above estimated risk for a child is far smaller than what would ordinarily be considered negligible.

	i. 	Food.

Food contact exposures are well below 100% of the cPAD, and are therefore below EPA's established level of concern for all U.S. subpopulations. The combined exposure for males, females, and infants and children is < 1% of the cPAD, even for the 100% worst case scenario.

 	ii. 	Drinking water.

Drinking water exposure is highly unlikely from the use of MSA as an inert ingredient in antimicrobial pesticide products. Moreover, MSA are readily biodegradable according to OECD criteria, which reduce the likelihood of residues on food. Exposures to residues above toxicity levels of concern are not anticipated.

 Cumulative Effects

MSA does not share a common mechanism of toxicity with any other pesticide active and/or inert ingredient.

 Safety Determination

The proposed use of MSA will not increase the current exposure due to other non-pesticide exposures. The food-contact sanitizer use for all population subgroups combined is <1% of the cPAD.

 U.S. population.

  The % cPAD calculated for males (0.14-0.29%) and females (0.17-0.33%) is well below the level of concern. Based on these conservative exposure estimates, there is a reasonable certainty that no harm will result to the U.S. population from the aggregate exposure to MSA.

 Infants and children.

  FFDCA Section 408 requires an additional tenfold margin of safety for the protection of infants and children in case of threshold effects to account for prenatal and postnatal toxicity, and an inadequate toxicity database. Where an adequate and reliable database is available and there is a lack of evidence for increased susceptibility, the FQPA safety factor may be reduced or removed.

  An evaluation of susceptibility and uncertainty issues associated with MSA has been performed, and EPA has previously reduced the FQPA safety factor from the default 10x to 1x for the following reasons:
 The availability of a substantial and scientifically sound mammalian toxicology database that includes acute, repeat dose, reproduction, developmental, and endocrine data for MSA;
 OECD testing indicating that there was no evidence of developmental toxicity or malformations in the developing offspring;
 There is no evidence to suggest that MSA would have an adverse effect on the reproductive organs;
 MSA does not belong to a class of chemicals known or suspected of having adverse effects on the estrogen receptor or endocrine system. MSA has been evaluated in acute, repeated dose, developmental, and chronic toxicity studies capable of detecting effects on endocrine mediated events and have not demonstrated any endocrine-related effects.

  The % cPAD calculated for infants and children (0.67-1.3%) is well below the level of concern. Based on these conservative exposure estimates, there is a reasonable certainty that no harm will result to infants and children from the aggregate exposure to MSA.

 International Tolerances

There are no CODEX MRLs established for MSA.


[Federal Register Volume 85, Number 195 (Wednesday, October 7, 2020)]
[Notices]
[Pages 63280-63282]
[FR Doc No: 2020-22186]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2020-N-1989]

Fee Rate for Using a Rare Pediatric Disease Priority Review
Voucher in Fiscal Year 2021

AGENCY: Food and Drug Administration, Health and Human Services (HHS).

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA or the Agency) is
announcing the fee rate for using a rare pediatric disease priority
review voucher for fiscal year (FY) 2021. The Federal Food, Drug, and
Cosmetic Act (FD&C Act), as amended by the Food and Drug Administration
Safety and Innovation Act (FDASIA), authorizes FDA to determine and
collect rare pediatric disease priority review user fees for certain
applications for review of human drug or biological products when those
applications use a rare pediatric disease priority review voucher.
These vouchers are awarded to sponsors of rare pediatric disease
product applications that meet all the requirements of this program and
are submitted 90 days or more after July 9, 2012, upon FDA approval of
such applications. The amount of the fee for using a rare pediatric
disease priority review voucher is determined each FY, based on the
difference between the average cost incurred by FDA to review a human
drug application designated as priority review in the previous FY, and
the average cost incurred in the review of an application that is not
subject to priority review in the previous FY. This notice establishes
the rare pediatric disease priority review fee rate for FY 2021 and
outlines the payment procedures for such fees.

FOR FURTHER INFORMATION CONTACT: Misbah Tareen, Office of Financial
Management, Food and Drug Administration, 4041 Powder Mill Rd., Rm.
61077A, Beltsville, MD 20705-4304,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    Section 908 of FDASIA (Pub. L. 112-144) added section 529 to the
FD&C Act (21 U.S.C. 360ff). In section 529 of the FD&C Act, Congress
encouraged development of new human drugs and biological products for
prevention and treatment of certain rare pediatric diseases by offering
additional incentives for obtaining FDA approval of such products.
Under section 529 of the FD&C Act, the sponsor of an eligible human
drug application submitted 90 days or more after July 9, 2012, for a
rare pediatric disease (as defined in section 529(a)(3)) shall receive
a priority review voucher upon approval of the rare pediatric disease
product application. The recipient of a rare pediatric disease priority
review voucher may either use the voucher for a future human drug
application submitted to FDA under section 505(b)(1) of the FD&C Act
(21 U.S.C. 355(b)(1)) or section 351(a) of the Public Health Service
Act (42 U.S.C. 262(a)), or transfer (including by sale) the voucher to
another party. The voucher may be transferred repeatedly until it
ultimately is used for a human drug application submitted to FDA under
section 505(b)(1) of the FD&C Act or section 351(a) of the Public
Health Service Act. A priority review is a review conducted with a
Prescription Drug User Fee Act (PDUFA) goal date of 6 months after the
receipt or filing date, depending on the type of application.
Information regarding current PDUFA goals is available at https://www.fda.gov/downloads/forindustry/userfees/prescriptiondruguserfee/ucm511438.pdf.
    The sponsor that uses a rare pediatric disease priority review
voucher is entitled to a priority review of its eligible human drug
application, but must pay FDA a rare pediatric disease priority review
user fee in addition to any user fee required by PDUFA for the
application. Information regarding the rare pediatric disease priority
review

voucher program is available at: https://www.fda.gov/Drugs/DevelopmentApprovalProcess/DevelopmentResources/ucm375479.htm.
    This notice establishes the rare pediatric disease priority review
fee rate for FY 2021 at $1,360,879 and outlines FDA's payment
procedures for rare pediatric disease priority review user fees. This
rate is effective on October 1, 2020, and will remain in effect through
September 30, 2021.

II. Rare Pediatric Priority Review User Fee Rate for FY 2021

    Under section 529(c)(2) of the FD&C Act, the amount of the rare
pediatric disease priority review user fee is determined each fiscal
year based on the difference between the average cost incurred by FDA
in the review of a human drug application subject to priority review in
the previous fiscal year, and the average cost incurred by FDA in the
review of a human drug application that is not subject to priority
review in the previous fiscal year.
    A priority review is a review conducted with a PDUFA goal date of 6
months after the receipt or filing date, depending on the type of
application. As described in the PDUFA goals letter, FDA has committed
to reviewing and acting on 90 percent of the applications granted
priority review status within this expedited timeframe. Normally, an
application for a human drug or biological product will qualify for
priority review if the product is intended to treat a serious condition
and, if approved, would provide a significant improvement in safety or
effectiveness. An application that does not receive a priority
designation receives a standard review. As described in the PDUFA goals
letter, FDA has committed to reviewing and acting on 90 percent of
standard applications within 10 months of the receipt or filing date
depending on the type of application. A priority review involves a more
intensive level of effort and a higher level of resources than a
standard review.
    FDA is setting a fee for FY 2021, which is to be based on standard
cost data from the previous fiscal year, FY 2020. However, the FY 2020
submission cohort has not been closed out yet, thus the cost data for
FY 2020 are not complete. The latest year for which FDA has complete
cost data is FY 2019. Furthermore, because FDA has never tracked the
cost of reviewing applications that get priority review as a separate
cost subset, FDA estimated this cost based on other data that the
Agency has tracked. The Agency expects all applications that received
priority review would contain clinical data. The application categories
with clinical data for which FDA tracks the cost of review are: (1) New
drug applications (NDAs) for a new molecular entity (NME) with clinical
data and (2) biologics license applications (BLAs).
    The total cost for FDA to review NME NDAs with clinical data and
BLAs in FY 2019 was $199,369,923. There was a total of 70 applications
in these two categories (49 NME NDAs with clinical data and 21 BLAs).
(Note: These numbers exclude the President's Emergency Plan for AIDS
Relief NDAs; no investigational new drug review costs are included in
this amount.) Forty-four of these applications (32 NDAs and 12 BLAs)
received priority review and the remaining 26 (17 NDAs and 9 BLAs)
received standard reviews. Because a priority review compresses a
review schedule that ordinarily takes 10 months into 6 months, FDA
estimates that a multiplier of 1.67 (10 months / 6 months) should be
applied to non-priority review costs in estimating the effort and cost
of a priority review as compared to a standard review. This multiplier
is consistent with published research on this subject, which supports a
priority review multiplier in the range of 1.48 to 2.35 (Ref. 1). Using
FY 2019 figures, the costs of a priority and standard review are
estimated using the following formula:

(44 [alpha] x 1.67) + (26 [alpha]) = $199,369,923

where ``[alpha]'' is the cost of a standard review and ``[alpha]
times 1.67'' is the cost of a priority review. Using this formula,
the cost of a standard review for NME NDAs and BLAs is calculated to
be $2,004,121 (rounded to the nearest dollar) and the cost of a
priority review for NME NDAs and BLAs is 1.67 times that amount, or
$3,346,882 (rounded to the nearest dollar). The difference between
these two cost estimates, or $1,342,761, represents the incremental
cost of conducting a priority review rather than a standard review.

    For the FY 2021 fee, FDA will need to adjust the FY 2019
incremental cost by the average amount by which FDA's average costs
increased in the 3 years prior to FY 2020, to adjust the FY 2019 amount
for cost increases in FY 2020. That adjustment, published in the
Federal Register on August 3, 2020 (see 85 FR 46651), setting the FY
2021 PDUFA fees, is 1.3493 percent for the most recent year, not
compounded. Increasing the FY 2019 incremental priority review cost of
$1,342,761 by 1.3493 percent (or 0.013493) results in an estimated cost
of $1,360,879 (rounded to the nearest dollar). This is the rare
pediatric disease priority review user fee amount for FY 2021 that must
be submitted with a priority review voucher for a human drug
application in FY 2021, in addition to any PDUFA fee that is required
for such an application.

III. Fee Rate Schedule for FY 2021

    The fee rate for FY 2021 is set in table 1:

  Table 1--Rare Pediatric Disease Priority Review Schedule for FY 2021
------------------------------------------------------------------------
                                                         Priority review
                      Fee category                       fee rate for FY
                                                               2021
------------------------------------------------------------------------
Application submitted with a rare pediatric disease          $1,360,879
 priority review voucher in addition to the normal
 PDUFA fee.............................................
------------------------------------------------------------------------

IV. Implementation of Rare Pediatric Disease Priority Review User Fee

    Under section 529(c)(4)(A) of the FD&C Act, the priority review
user fee is due (i.e., the obligation to pay the fee is incurred) when
a sponsor notifies FDA of its intent to use the voucher. Section
529(c)(4)(B) of the FD&C Act specifies that the application will be
considered incomplete if the priority review user fee and all other
applicable user fees are not paid in accordance with FDA payment
procedures. In addition, section 529(c)(4)(C) specifies that FDA may
not grant a waiver, exemption, reduction, or refund of any fees due and
payable under this section of the FD&C Act.
    The rare pediatric disease priority review fee established in the
new fee schedule must be paid for applications submitted with a
priority review voucher received on or after October 1, 2020. In order
to comply with this requirement, the sponsor must notify FDA 90 days
prior to submission of the human drug application that is the subject
of a priority review voucher of

an intent to submit the human drug application, including the estimated
submission date.
    Upon receipt of this notification, FDA will issue an invoice to the
sponsor for the rare pediatric disease priority review voucher fee. The
invoice will include instructions on how to pay the fee via wire
transfer, check, or online payments.
    As noted in section II, if a sponsor uses a rare pediatric disease
priority review voucher for a human drug application, the sponsor would
incur the rare pediatric disease priority review voucher fee in
addition to any PDUFA fee that is required for the application. The
sponsor would need to follow FDA's normal procedures for timely payment
of the PDUFA fee for the human drug application.
    Payment must be made in U.S. currency by electronic check, check,
bank draft, wire transfer, credit card, or U.S. postal money order
payable to the order of the Food and Drug Administration. The preferred
payment method is online using electronic check (Automated Clearing
House (ACH) also known as eCheck). Secure electronic payments can be
submitted using the User Fees Payment Portal at https://userfees.fda.gov/pay (Note: Only full payments are accepted. No partial
payments can be made online). Once you search for your invoice, select
``Pay Now'' to be redirected to Pay.gov. Note that electronic payment
options are based on the balance due. Payment by credit card is
available for balances that are less than $25,000. If the balance
exceeds this amount, only the ACH option is available. Payments must be
made using U.S bank accounts as well as U.S. credit cards.
    If paying by paper check the invoice number should be included on
the check, followed by the words ``Rare Pediatric Disease Priority
Review.'' All paper checks must be in U.S. currency from a U.S. bank
made payable and mailed to: Food and Drug Administration, P.O. Box
979107, St. Louis, MO 63197-9000.
    If checks are sent by a courier that requests a street address, the
courier can deliver the checks to: U.S. Bank, Attention: Government
Lockbox 979107, 1005 Convention Plaza, St. Louis, MO 63101. (Note: This
U.S. Bank address is for courier delivery only. If you have any
questions concerning courier delivery contact the U.S. Bank at 314-418-
4013. This telephone number is only for questions about courier
delivery). The FDA post office box number (P.O. Box 979107) must be
written on the check. If needed, FDA's tax identification number is 53-
0196965.
    If paying by wire transfer, please reference your invoice number
when completing your transfer. The originating financial institution
may charge a wire transfer fee. If the financial institution charges a
wire transfer fee it is required to add that amount to the payment to
ensure that the invoice is paid in full. The account information is as
follows: U.S. Dept. of the Treasury, TREAS NYC, 33 Liberty St., New
York, NY 10045, Account Number: 75060099, Routing Number: 021030004,
SWIFT: FRNYUS33.

V. Reference

    The following reference is on display at the Dockets Management
Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm.
1061, Rockville, MD 20852) and is available for viewing by interested
persons between 9 a.m. and 4 p.m., Monday through Friday; it is not
available electronically at https://www.regulations.gov as this
reference is copyright protected. FDA has verified the website address,
as of the date this document publishes in the Federal Register, but
websites are subject to change over time.

1. Ridley, D.B., H.G. Grabowski, and J.L. Moe, ``Developing Drugs
for Developing Countries,'' Health Affairs, vol. 25, no. 2, pp. 313-
324, 2006, available at: https://www.healthaffairs.org/doi/full/10.1377/hlthaff.25.2.313.

    Dated: October 2, 2020.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2020-22186 Filed 10-2-20; 4:15 pm]
BILLING CODE 4164-01-P


[Federal Register Volume 85, Number 83 (Wednesday, April 29, 2020)]
[Notices]
[Pages 23825-23826]
[FR Doc No: 2020-09028]

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OECA-2013-0319; FRL-10008-95-OMS]

Information Collection Request Submitted to OMB for Review and
Approval; Comment Request; NSPS for VOC Emissions From Petroleum
Refinery Wastewater Systems (Renewal)

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: The Environmental Protection Agency (EPA) has submitted an
information collection request (ICR), NSPS for VOC Emissions from
Petroleum Refinery Wastewater Systems (EPA ICR Number 1136.13, OMB
Control Number 2060-0172), to the Office of Management and Budget (OMB)
for review and approval in accordance with the Paperwork Reduction Act.
This is a proposed extension of the ICR, which is currently approved
through June 30, 2020. Public comments were previously requested via
the Federal Register on May 6, 2019 during a 60-day comment period.
This notice allows for an additional 30 days for public comments. A
fuller description of the ICR is given below, including its estimated
burden and cost to the public. An agency may neither conduct nor
sponsor, and a person is not required to respond to, a collection of
information unless it displays a currently valid OMB control number.

DATES: Additional comments may be submitted on or before May 29, 2020.

ADDRESSES: Submit your comments to EPA, referencing Docket ID Number
EPA-HQ-OECA-2013-0319, online using www.regulations.gov (our preferred
method), or by email to<EMAIL_ADDRESS>or by mail to: EPA Docket
Center, Environmental Protection Agency, Mail Code 28221T, 1200
Pennsylvania Ave. NW, Washington, DC 20460. EPA's policy is that all
comments received will be included in the public docket without change
including any personal information provided, unless the comment
includes profanity, threats, information claimed to be Confidential
Business Information (CBI), or other information whose disclosure is
restricted by statute.
    Submit written comments and recommendations to OMB for the proposed
information collection within 30 days of publication of this notice to
www.reginfo.gov/public/do/PRAMain. Find this particular information
collection by selecting ``Currently under 30-day Review--Open for
Public Comments'' or by using the search function.

FOR FURTHER INFORMATION CONTACT: Patrick Yellin, Monitoring,
Assistance, and Media Programs Division, Office of Compliance, Mail
Code 2227A, Environmental Protection Agency, 1200 Pennsylvania Ave. NW,
Washington, DC 20460; telephone number:<PHONE_NUMBER>; fax number:
(202) 564-0050; email address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Supporting documents, which explain in
detail the information that the EPA will be collecting, are available
in the public docket for this ICR. The docket can be viewed online at
www.regulations.gov, or in person at the EPA Docket Center, WJC West,
Room 3334, 1301 Constitution Ave. NW, Washington, DC. The telephone
number for the Docket Center is<PHONE_NUMBER>. For additional
information about EPA's public docket, visit: http://www.epa.gov/dockets.
    Abstract: The New Source Performance Standards (NSPS) for VOC
Emissions from Petroleum Refinery Wastewater Systems (40 CFR part 60,
subpart QQQ) were proposed on May 4, 1987, and promulgated on November
23, 1988. These regulations apply to existing facilities and new
wastewater systems at petroleum refineries, and cover individual drain
systems, oil-water separators, and aggregate facilities. An individual
drain system consists of all process drains connected to the first
downstream junction box. An oil-water separator is the wastewater
treatment equipment used to separate oil from water. An aggregate
facility is an individual drain system together with ancillary
downstream sewer lines and oil-water separators, down to and including
the secondary oil-water separator, as applicable. Aggregate facilities
are intended to capture any potential VOC emissions within the
petroleum refinery wastewater system during expansions of and additions
to the system. New facilities include those that commenced
construction, modification, or reconstruction after the date of
proposal. This information is being collected to assure compliance with
40 CFR part 60, subpart QQQ.

    In general, all NSPS standards require initial notifications,
performance tests, and periodic reports by the owners/operators of the
affected facilities. They are also required to maintain records of the
occurrence and duration of any startup, shutdown, or malfunction in the
operation of an affected facility, or during any period in which the
monitoring system is inoperative. These notifications, reports, and
records are essential in determining compliance, and are required of
all affected facilities subject to NSPS.
    Form Numbers: None.
    Respondents/affected entities: Petroleum refinery wastewater
systems.
    Respondent's obligation to respond: Mandatory (40 CFR part 60,
subpart QQQ).
    Estimated number of respondents: 149 (total).
    Frequency of response: Initially, occasionally, and semiannually.
    Total estimated burden: 10,200 hours (per year). Burden is defined
at 5 CFR 1320.3(b).
    Total estimated cost: $1,200,000 (per year), which includes $19,400
in annualized capital/startup and/or operation & maintenance costs.
    Changes in the Estimates: The burden in labor hours is unchanged
from the previous ICR renewal and the number of responses is unchanged.
The costs of performance testing and CEMS monitoring are unchanged from
the previous ICR renewal. The regulations have not changed over the
past three years and are not anticipated to change over the next three
years. The growth rate for the industry is very low, negative or non-
existent, so there is no change in the estimate of the number of
sources subject to this regulation since the previous ICR renewal.

Courtney Kerwin,
Director, Regulatory Support Division.
[FR Doc. 2020-09028 Filed 4-28-20; 8:45 am]
BILLING CODE 6560-50-P