Notice of Intent To Suspend Certain Pesticide Registrations, 54563-54572 [2020-19370]
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Federal Register / Vol. 85, No. 171 / Wednesday, September 2, 2020 / Notices
Table in Unit IV pursuant to section 3(g)
of the Federal Insecticide, Fungicide,
and Rodenticide Act (FIFRA) and the
Procedural Regulations for Registration
Review at 40 CFR part 155, subpart C.
Section 3(g) of FIFRA provides, among
other things, that the registrations of
pesticides are to be reviewed every 15
years. Under FIFRA, a pesticide product
may be registered or remain registered
only if it meets the statutory standard
for registration given in FIFRA section
3(c)(5) (7 U.S.C. 136a(c)(5)). When used
in accordance with widespread and
commonly recognized practice, the
pesticide product must perform its
intended function without unreasonable
adverse effects on the environment; that
is, without any unreasonable risk to
man or the environment, or a human
dietary risk from residues that result
from the use of a pesticide in or on food.
54563
IV. What action is the Agency taking?
Pursuant to 40 CFR 155.58, this notice
announces the availability of EPA’s
human health and/or ecological risk
assessments for the pesticides shown in
the following table and opens a 60-day
public comment period on the risk
assessments.
TABLE—DRAFT RISK ASSESSMENTS BEING MADE AVAILABLE FOR PUBLIC COMMENT
Registration review case name and No.
Docket ID No.
10,10’-oxybisphenoxarsine, (OBPA), Case 0044 ...............
Amicarbazone, Case 7262 .................................................
Aminopyralid, Case 7267 ...................................................
Dimethenamid/Dimethenamid-p, Case 7223 .....................
Endothall, Case 2245 .........................................................
Fluoxastrobin, Case 7044 ..................................................
Folpet, Case 0630 ..............................................................
Ipconazole (eco only), Case 7041 .....................................
Iprodione, Case 2335 .........................................................
Metconazole, Case 7049 ....................................................
Polixetonium chloride (Busan 77), Case 3034 ...................
Prothioconazole, Case 7054 ..............................................
jbell on DSKJLSW7X2PROD with NOTICES
Sodium pyrithione, Case 0209 ...........................................
Pursuant to 40 CFR 155.53(c), EPA is
providing an opportunity, through this
notice of availability, for interested
parties to provide comments and input
concerning the Agency’s draft human
health and/or ecological risk
assessments for the pesticides listed in
the Table in Unit IV. The Agency will
consider all comments received during
the public comment period and make
changes, as appropriate, to a draft
human health and/or ecological risk
assessment. EPA may then issue a
revised risk assessment, explain any
changes to the draft risk assessment, and
respond to comments.
Information submission requirements.
Anyone may submit data or information
in response to this document. To be
considered during a pesticide’s
registration review, the submitted data
or information must meet the following
requirements:
• To ensure that EPA will consider
data or information submitted,
interested persons must submit the data
or information during the comment
VerDate Sep<11>2014
17:33 Sep 01, 2020
Jkt 250001
EPA–HQ–OPP–2009–
0618.
EPA–HQ–OPP–2015–
0400.
EPA–HQ–OPP–2013–
0749.
EPA–HQ–OPP–2015–
0803.
EPA–HQ–OPP–2015–
0591.
EPA–HQ–OPP–2015–
0295.
EPA–HQ–OPP–2012–
0859.
EPA–HQ–OPP–2015–
0590.
EPA–HQ- OPP–2012–
0392.
EPA–HQ–OPP–2015–
0013.
EPA–HQ–OPP–2015–
0256.
EPA–HQ–OPP–2015–
0474.
EPA–HQ–OPP–2011–
0611.
Chemical review manager and contact information
Megan Snyderman, snyderman.megan@epa.gov, (703)
347–0671.
Samantha Thomas, thomas.samantha@epa.gov, (703)
347–0514.
Veronica Dutch, dutch.veronica@epa.gov, 703–308–
8585.
Lauren Weissenborn, weissenborn.lauren@epa.gov,
(703) 347–8601.
Robert Little, little.robert@epa.gov, (703) 347–8156.
Rachel Fletcher, fletcher.rachel@epa.gov, (703) 347–
0512.
Christina Scheltema, scheltema.christina@epa.gov, (703)
308–2201.
Lauren Bailey, bailey.lauren@epa.gov, (703) 347–0734.
Rachel Fletcher, fletcher.rachel@epa.gov, (703) 347–
0512.
Jordan Page, page.jordan@epa.gov, (703) 347–0467.
Peter Bergquist, bergquist.peter@epa.gov, (703) 347–
8563.
Rachel Eberius, eberius.rachel@epa.gov, (703) 347–
0492.
Kendall Ziner, ziner.kendall@epa.gov, (703) 347–8829.
period. The Agency may, at its
discretion, consider data or information
submitted at a later date.
• The data or information submitted
must be presented in a legible and
useable form. For example, an English
translation must accompany any
material that is not in English and a
written transcript must accompany any
information submitted as an audiographic or video-graphic record. Written
material may be submitted in paper or
electronic form.
• Submitters must clearly identify the
source of any submitted data or
information.
• Submitters may request the Agency
to reconsider data or information that
the Agency rejected in a previous
review. However, submitters must
explain why they believe the Agency
should reconsider the data or
information in the pesticide’s
registration review.
As provided in 40 CFR 155.58, the
registration review docket for each
pesticide case will remain publicly
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accessible through the duration of the
registration review process; that is, until
all actions required in the final decision
on the registration review case have
been completed.
Authority: 7 U.S.C. 136 et seq.
Dated: July 23, 2020.
Mary Reaves,
Acting Director, Pesticide Re-Evaluation
Division, Office of Pesticide Programs.
[FR Doc. 2020–19371 Filed 9–1–20; 8:45 am]
BILLING CODE 6560–50–P
ENVIRONMENTAL PROTECTION
AGENCY
[EPA–HQ–OPP–2019–0565; FRL–10003–30]
Notice of Intent To Suspend Certain
Pesticide Registrations
Environmental Protection
Agency (EPA).
ACTION: Notice.
AGENCY:
This notice, pursuant the
Federal Insecticide, Fungicide and
SUMMARY:
E:\FR\FM\02SEN1.SGM
02SEN1
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Federal Register / Vol. 85, No. 171 / Wednesday, September 2, 2020 / Notices
Rodenticide Act (FIFRA), publishes a
Notice of Intent to Suspend certain
pesticide registrations issued by EPA.
The Notice of Intent to Suspend was
issued following the Agency’s issuance
of a Data Call-In Notice (DCI), which
required the registrant of the affected
pesticide products containing a certain
pesticide active ingredient to take
appropriate steps to secure certain data,
and following the registrant’s failure to
submit these data or to take other
appropriate steps to secure the required
data. The subject data were determined
to be required to maintain in effect the
existing registrations of the affected
products. Failure to comply with the
data requirements of a DCI is a basis for
suspension of the affected registrations
under FIFRA.
DATES: The Notice of Intent to Suspend
included in this Federal Register notice
will become a final and effective
suspension order automatically by
operation of law 30 days after the date
of the registrant’s receipt of the mailed
Notice of Intent to Suspend or, if the
mailed Notice of Intent to Suspend is
returned to the EPA Administrator as
undeliverable, if delivery is refused, or
if the EPA Administrator otherwise is
unable to accomplish delivery to the
registrant after making reasonable efforts
to do so, the Notice of Intent to Suspend
becomes effective 30 days after the date
of publication of this notice in the
Federal Register, unless, during that
time, a timely and adequate request for
a hearing is made by a person adversely
affected by the Notice of Intent to
Suspend, or the registrant has satisfied
the EPA Administrator that the
registrant has complied fully with the
requirements that served as a basis for
the Notice of Intent to Suspend. Unit IV.
explains what must be done to avoid
suspension under this notice (i.e., how
to request a hearing or how to comply
fully with the requirements that served
as a basis for the Notice of Intent to
Suspend).
Erin
Dandridge, Antimicrobial Division
(7510P), Office of Pesticide Programs,
Environmental Protection Agency, 1200
Pennsylvania Ave. NW, Washington, DC
20460–0001, telephone number: (703)
347–0185, email: dandridge.erin@
epa.gov.
FOR FURTHER INFORMATION CONTACT:
SUPPLEMENTARY INFORMATION:
I. General Information
A. Does this action apply to me?
This action is directed to the public
in general and may be of interest to a
wide range of stakeholders including
environmental, human health, farm
worker and agricultural advocates; the
chemical industry; pesticide users; and
members of the public interested in the
sale, distribution, or use of pesticides.
Since others also may be interested, the
Agency has not attempted to describe all
the specific entities that may be affected
by this action.
B. How can I get copies of this document
and other related information?
The docket for this action, identified
by docket identification (ID) number
EPA–HQ–OPP–2019–0565, is available
at https://www.regulations.gov or at the
Office of Pesticide Programs Regulatory
Public Docket (OPP Docket) in the
Environmental Protection Agency
Docket Center (EPA/DC), William
Jefferson Clinton West Building., Room.
3334, 1301 Constitution Ave. NW,
Washington, DC 20460–0001. The
Public Reading Room is open from 8:30
a.m. to 4:30 p.m., Monday through
Friday, excluding legal holidays. The
telephone number for the Public
Reading Room is (202) 566–1744, and
the telephone number for the OPP
Docket is (703) 305–5805. Please review
the visitor instructions and additional
information about the docket available
at https://www.epa.gov/dockets.
II. Registrant Issued Notice of Intent To
Suspend Active Ingredient, Product(s)
Affected, and Date(s) Issued
The registrant and products subject to
this Notice of Intent to Suspend are
listed in Table 1. A Notice of Intent to
Suspend was sent to the registrant of the
affected products via the U.S. Postal
Service, first class mail, return receipt
requested.
TABLE 1—LIST OF REGISTRANT AND PRODUCTS SUBJECT TO SUSPENSION
Active ingredient
Qualco, Inc. ............
Dialkyl*methyl benzyl ammonium chloride *(60%C14, 30%
C16, 5% C18, 5% C12).
3525–22
Qualco, Inc. ............
Dialkyl*methyl benzyl ammonium chloride *(60%C14, 30%
C16, 5% C18, 5% C12).
Alkyl*dimethyl benzyl ammonium chloride* (60%C14,
30%C16, 5%C18, 5%C12).
3525–78
Alkyl* dimethyl benzyl
25%C12, 15%C16).
Alkyl* dimethyl benzyl
25%C12, 15%C16).
Alkyl* dimethyl benzyl
25%C12, 15%C16).
Alkyl* dimethyl benzyl
25%C12, 15%C16).
ammonium chloride *(60%C14,
3525–97
ammonium chloride *(60%C14,
3525–99
ammonium chloride *(60%C14,
3525–100
ammonium chloride *(60%C14,
3525–103
Qualco, Inc. ............
Alkyl* dimethyl benzyl ammonium chloride *(95%C14,
3%C12, 2%C16).
3525–104
Qualco, Inc. ............
Dialkyl*methyl benzyl ammonium chloride *(60%C14, 30%
C16, 5% C18, 5% C12).
3525–106
Qualco, Inc. ............
Qualco, Inc. ............
Qualco, Inc. ............
Qualco, Inc. ............
Qualco, Inc. ............
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EPA registration
No.
Registrant affected
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3525–94
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Product name
Utikem
Algaesan
Multi-Purpose
Algaecide.
Algae Destroyer.
Coastal Pool
Aid Powder
Surface
Sanitizer.
Winter Aid ......
Coastal Pool
Deodor.
Winter Tablets
‘‘G’’.
Cal Jet
Algaecide
Liquid.
Iso Clor ‘‘C’’
Super Stabilized
Chlorinating
Powder.
Liquid
Algaecide.
02SEN1
Date EPA issued
notice of intent
to suspend
July 27, 2020.
July 27, 2020.
July 27, 2020.
July 27, 2020.
July 27, 2020.
July 27, 2020.
July 27, 2020.
July 27, 2020.
July 27, 2020.
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Federal Register / Vol. 85, No. 171 / Wednesday, September 2, 2020 / Notices
TABLE 1—LIST OF REGISTRANT AND PRODUCTS SUBJECT TO SUSPENSION—Continued
EPA registration
No.
Registrant affected
Active ingredient
Qualco, Inc. ............
Dialkyl*methyl benzyl ammonium chloride *(60%C14, 30%
C16, 5% C18, 5% C12).
III. Basis for Issuance of Notice of
Intent To Suspend; Requirement List
The registrant failed to submit the
data or information required by the Data
Call-In Notice, or to take other
appropriate steps to secure the required
data for their pesticide products listed
in Table 2 of this unit.
3525–118
While the Agency did not receive a
certified mail return receipt from Ms.
Schaub, the agent for Qualco, Inc., or
from Qualco, Inc. for the Product
Specific Data Call-In (PDCI) Notice
requiring data generation and
submission for EPA Reg. Nos. 3525–22,
3525–78, 3525–94, 3524–97, 3525–99,
Date EPA issued
notice of intent
to suspend
Product name
Coastal Concentrate 50.
July 27, 2020.
3525–100, 3525–103, 3525–104, 3525–
106, and 3525–118, the agency has
correspondence from the company’s
representative after the PDCI Notices
were issued evidencing that Ms. Schaub
and thus Qualco, Inc. received the
PDCIs and were aware of the data
requirements.
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TABLE 2–A—LIST OF REQUIREMENTS FOR EPA REGISTRATION NUMBER 3525–94
Guideline No.
as listed
in applicable
DCI
Requirement name
830.1550 ........
Product Identity and Composition ....
3/11/2015
830.1600 ........
3/11/2015
830.1620 ........
Description of Materials Used to
Produce the Product.
Description of Production Process ...
3/11/2015
830.1650 ........
Description of Formulation Process
3/11/2015
830.1670 ........
3/11/2015
830.1700 ........
Discussion of Formation of Impurities.
Preliminary Analysis .........................
3/11/2015
830.1750 ........
Certified Limits ..................................
3/11/2015
830.1800 ........
Enforcement Analytical Method .......
3/11/2015
830.6302 ........
Color .................................................
3/11/2015
830.6303 ........
Physical State ...................................
3/11/2015
830.6304 ........
Odor ..................................................
3/11/2015
830.6313 ........
3/11/2015
830.6314 ........
Stability to Normal and Elevated
Temperatures,Metals, and Metal.
Oxidizing or Reducing Action ...........
3/11/2015
830.6315 ........
Flammability .....................................
3/11/2015
830.6316 ........
Explodability .....................................
3/11/2015
830.6317 ........
Storage Stability ...............................
3/11/2015
830.6319 ........
Miscibility ..........................................
3/11/2015
830.6320 ........
Corrosion Characteristics .................
3/11/2015
830.6321 ........
Dielectric Breakdown Voltage ..........
3/11/2015
830.7000 ........
pH .....................................................
3/11/2015
830.7050 ........
UV/Visible Absorption .......................
3/11/2015
830.7100 ........
Viscosity ...........................................
3/11/2015
830.7200 ........
Melting Point/Melting Range ............
3/11/2015
830.7220 ........
Boiling Point/Boiling Range ..............
3/11/2015
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Date EPA
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Date registrant
received DCI
Confirmation
ence.
Confirmation
ence.
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ence.
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Confirmation
ence.
Confirmation
ence.
Confirmation
ence.
Confirmation
ence.
Confirmation
ence.
Confirmation
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Confirmation
ence.
Confirmation
ence.
Confirmation
ence.
Confirmation
ence.
Confirmation
ence.
Confirmation
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Confirmation
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Confirmation
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Confirmation
ence.
Confirmation
ence.
Confirmation
ence.
Confirmation
ence.
Confirmation
ence.
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Final data
due date
Reason for
notice of
intent to
suspend *
through Correspond-
11/09/2015
2&4
through Correspond-
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Federal Register / Vol. 85, No. 171 / Wednesday, September 2, 2020 / Notices
TABLE 2–A—LIST OF REQUIREMENTS FOR EPA REGISTRATION NUMBER 3525–94—Continued
Guideline No.
as listed
in applicable
DCI
Requirement name
830.7300 ........
Density/Relative Density ..................
3/11/2015
830.7370 ........
Dissociation Constants in Water ......
3/11/2015
830.7550 ........
3/11/2015
830. 7950 .......
Partition
Coefficient
(n-octanol/
water), Shake Flask Method.
Partition Coefficient (n-octanol/water,
Generator Column Method.
Partition Coefficient (n-octanol/water,
Estimation by Liquid Chromatography.
Water Solubility: Column Elution
Method, Shake Flask Method.
Water Solubility, Generator Column
Method.
Vapor Pressure ................................
870.1100 ........
Acute Oral Toxicity ...........................
3/11/2015
870.1200 ........
Acute Dermal Toxicity ......................
3/11/2015
870.1300 ........
Acute Inhalation Toxicity ..................
3/11/2015
870.2500 ........
Acute Dermal Irritation .....................
3/11/2015
870.2600 ........
Skin Sensitization .............................
3/11/2015
870.2400 ........
Acute Eye Irritation ...........................
3/11/2015
810.2100 ........
Sterilants ...........................................
3/11/2015
810.2200 ........
Disinfectants for Use on Hard Surfaces.
Sanitizers for Use on Hard Surfaces
3/11/2015
830.7560 ........
830.7570 ........
830.7840 ........
830.7860 ........
810.2300 ........
810.2400 ........
Date EPA
issued DCI
3/11/2015
3/11/2015
3/11/2015
3/11/2015
3/11/2015
3/11/2015
810.2500 ........
Disinfectants and Sanitizers for Use
on Fabrics and Textiles.
Air Sanitizers ....................................
3/11/2015
3/11/2015
810.2600 ........
Disinfectants for Use in Water .........
3/11/2015
Date registrant
received DCI
Confirmation
ence.
Confirmation
ence.
Confirmation
ence.
Confirmation
ence.
Confirmation
ence.
Confirmation
ence.
Confirmation
ence.
Confirmation
ence.
Confirmation
ence.
Confirmation
ence.
Confirmation
ence.
Confirmation
ence.
Confirmation
ence.
Confirmation
ence.
Confirmation
ence.
Confirmation
ence.
Confirmation
ence.
Confirmation
ence.
Confirmation
ence.
Confirmation
ence.
Final data
due date
Reason for
notice of
intent to
suspend *
through Correspond-
11/09/2015
2&4
through Correspond-
11/09/2015
2&4
through Correspond-
11/09/2015
2&4
through Correspond-
11/09/2015
2&4
through Correspond-
11/09/2015
2&4
through Correspond-
11/09/2015
2&4
through Correspond-
11/09/2015
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through Correspond-
11/09/2015
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through Correspond-
11/09/2015
2&4
through Correspond-
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through Correspond-
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through Correspond-
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through Correspond-
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through Correspond-
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through Correspond-
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through Correspond-
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through Correspond-
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through Correspond-
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through Correspond-
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2&4
* Table Notes:
1 No 90-day response received.
2 Inadequate 90-day response received.
3 No data received.
4 Inadequate data received.
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TABLE 2–B—LIST OF REQUIREMENTS FOR EPA REGISTRATION NUMBERS: 3525–22; 3525–78; 3525–97; 3525–99;
3525–100; 3525–103; 3525–106; AND 3525–118
Guideline No.
as listed
in applicable
DCI
Requirement
name
830.1550 ........
Product Identity and Composition ....
3/06/2015
830.1600 ........
3/06/2015
830.1620 ........
Description of Materials Used to
Produce the Product.
Description of Production Process ...
3/06/2015
830.1650 ........
Description of Formulation Process
3/06/2015
830.1670 ........
3/06/2015
830.1700 ........
Discussion of Formation of Impurities.
Preliminary Analysis .........................
3/06/2015
830.1750 ........
Certified Limits ..................................
3/06/2015
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Date EPA
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Date registrant received DCI
Confirmation
ence.
Confirmation
ence.
Confirmation
ence.
Confirmation
ence.
Confirmation
ence.
Confirmation
ence.
Confirmation
ence.
Sfmt 4703
Final data
due date
Reason for
notice of
intent to
suspend *
through Correspond-
11/04/2015
2&4
through Correspond-
11/04/2015
2&4
through Correspond-
11/04/2015
2&4
through Correspond-
11/04/2015
2&4
through Correspond-
11/04/2015
2&4
through Correspond-
11/04/2015
2&4
through Correspond-
11/04/2015
2&4
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TABLE 2–B—LIST OF REQUIREMENTS FOR EPA REGISTRATION NUMBERS: 3525–22; 3525–78; 3525–97; 3525–99;
3525–100; 3525–103; 3525–106; AND 3525–118—Continued
Guideline No.
as listed
in applicable
DCI
Requirement
name
830.1800 ........
Enforcement Analytical Method .......
3/06/2015
830.6302 ........
Color .................................................
3/06/2015
830.6303 ........
Physical State ...................................
3/06/2015
830.6304 ........
Odor ..................................................
3/06/2015
830.6313 ........
3/06/2015
830.6314 ........
Stability to Normal and Elevated
Temperatures, Metals, and Metal.
Oxidizing or Reducing Action ...........
3/06/2015
830.6315 ........
Flammability .....................................
3/06/2015
830.6316 ........
Explodability .....................................
3/06/2015
830.6317 ........
Storage Stability ...............................
3/06/2015
830.6319 ........
Miscibility ..........................................
3/06/2015
830.6320 ........
Corrosion Characteristics .................
3/06/2015
830.6321 ........
Dielectric Breakdown Voltage ..........
3/06/2015
830.7000 ........
pH .....................................................
3/06/2015
830.7050 ........
UV/Visible Absorption .......................
3/06/2015
830.7100 ........
Viscosity ...........................................
3/06/2015
830.7200 ........
Melting Point/Melting Range ............
3/06/2015
830.7220 ........
Boiling Point/Boiling Range ..............
3/06/2015
830.7300 ........
Density/Relative Density ..................
3/06/2015
830.7370 ........
Dissociation Constants in Water ......
3/06/2015
830.7550 ........
3/06/2015
830.7950 ........
Partition
Coefficient
(n-octanol/
water), Shake Flask Method.
Partition Coefficient (n-octanol/water,
Generator Column Method.
Partition Coefficient (n-octanol/water,
Estimation by Liquid Chromatography.
Water Solubility: Column Elution
Method, Shake Flask Method.
Water Solubility, Generator Column
Method.
Vapor Pressure ................................
870.1100 ........
Acute Oral Toxicity ...........................
3/06/2015
870.1200 ........
Acute Dermal Toxicity ......................
3/06/2015
870.1300 ........
Acute Inhalation Toxicity ..................
3/06/2015
870.2500 ........
Acute Dermal Irritation .....................
3/06/2015
870.2600 ........
Skin Sensitization .............................
3/06/2015
870.2400 ........
Acute Eye Irritation ...........................
3/06/2015
810.2100 ........
Sterilants ...........................................
3/06/2015
810.2200 ........
Disinfectants for Use on Hard Surfaces.
3/06/2015
830.7560 ........
830.7570 ........
830.7840 ........
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830.7860 ........
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3/06/2015
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ence.
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ence.
Confirmation
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Confirmation
ence.
Confirmation
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Confirmation
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Confirmation
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Confirmation
ence.
Confirmation
ence.
Confirmation
ence.
Confirmation
ence.
Confirmation
ence.
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Final data
due date
Reason for
notice of
intent to
suspend *
through Correspond-
11/04/2015
2&4
through Correspond-
11/04/2015
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11/04/2015
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through Correspond-
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through Correspond-
11/04/2015
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through Correspond-
11/04/2015
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through Correspond-
11/04/2015
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through Correspond-
11/04/2015
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through Correspond-
11/04/2015
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through Correspond-
11/04/2015
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through Correspond-
11/04/2015
2&4
through Correspond-
11/04/2015
2&4
through Correspond-
11/04/2015
2&4
through Correspond-
11/04/2015
2&4
through Correspond-
11/04/2015
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through Correspond-
11/04/2015
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TABLE 2–B—LIST OF REQUIREMENTS FOR EPA REGISTRATION NUMBERS: 3525–22; 3525–78; 3525–97; 3525–99;
3525–100; 3525–103; 3525–106; AND 3525–118—Continued
Guideline No.
as listed
in applicable
DCI
Requirement
name
810.2300 ........
Sanitizers for Use on Hard Surfaces
3/06/2015
810.2400 ........
3/06/2015
810.2500 ........
Disinfectants and Sanitizers for Use
on Fabrics and Textiles.
Air Sanitizers ....................................
3/06/2015
810.2600 ........
Disinfectants for Use in Water .........
3/06/2015
Date EPA
issued DCI
Date registrant received DCI
Confirmation
ence.
Confirmation
ence.
Confirmation
ence.
Confirmation
ence.
Final data
due date
Reason for
notice of
intent to
suspend *
through Correspond-
11/04/2015
2&4
through Correspond-
11/04/2015
2&4
through Correspond-
11/04/2015
2&4
through Correspond-
11/04/2015
2&4
* Table Notes:
1 No 90-day response received.
2 Inadequate 90-day response received.
3 No data received.
4 Inadequate data received.
jbell on DSKJLSW7X2PROD with NOTICES
TABLE 2–C—LIST OF REQUIREMENTS FOR EPA REGISTRATION NUMBER 3525–104
Guideline No.
as listed
in applicable
DCI
Requirement name
830.1550 ........
Product Identity and Composition ....
3/04/2015
830.1600 ........
3/04/2015
830.1620 ........
Description of Materials Used to
Produce the Product.
Description of Production Process ...
3/04/2015
830.1650 ........
Description of Formulation Process
3/04/2015
830.1670 ........
3/04/2015
830.1700 ........
Discussion of Formation of Impurities.
Preliminary Analysis .........................
3/04/2015
830.1750 ........
Certified Limits ..................................
3/04/2015
830.1800 ........
Enforcement Analytical Method .......
3/04/2015
830.6302 ........
Color .................................................
3/04/2015
830.6303 ........
Physical State ...................................
3/04/2015
830.6304 ........
Odor ..................................................
3/04/2015
830.6313 ........
3/04/2015
830.6314 ........
Stability to Normal and Elevated
Temperatures, Metals, and Metal.
Oxidizing or Reducing Action ...........
3/04/2015
830.6315 ........
Flammability .....................................
3/04/2015
830.6316 ........
Explodability .....................................
3/04/2015
830.6317 ........
Storage Stability ...............................
3/04/2015
830.6319 ........
Miscibility ..........................................
3/04/2015
830.6320 ........
Corrosion Characteristics .................
3/04/2015
830.6321 ........
Dielectric Breakdown Voltage ..........
3/04/2015
830.7000 ........
pH .....................................................
3/04/2015
830.7050 ........
UV/Visible Absorption .......................
3/04/2015
830.7100 ........
Viscosity ...........................................
3/04/2015
830.7200 ........
Melting Point/Melting Range ............
3/04/2015
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ence.
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ence.
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ence.
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ence.
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ence.
Confirmation
ence.
Confirmation
ence.
Confirmation
ence.
Confirmation
ence.
Confirmation
ence.
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ence.
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ence.
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ence.
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ence.
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ence.
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ence.
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ence.
Confirmation
ence.
Confirmation
ence.
Confirmation
ence.
Confirmation
ence.
Sfmt 4703
Final data
due date
Reason for
notice of
intent to
suspend *
through Correspond-
11/02/2015
1&3
through Correspond-
11/02/2015
1&3
through Correspond-
11/02/2015
1&3
through Correspond-
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1&3
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54569
TABLE 2–C—LIST OF REQUIREMENTS FOR EPA REGISTRATION NUMBER 3525–104—Continued
Guideline No.
as listed
in applicable
DCI
Requirement name
830.7220 ........
Boiling Point/Boiling Range ..............
3/04/2015
830.7300 ........
Density/Relative Density ..................
3/04/2015
830.7370 ........
Dissociation Constants in Water ......
3/04/2015
830.7550 ........
3/04/2015
830.7950 ........
Partition
Coefficient
(n-octanol/
water), Shake Flask Method.
Partition
Coefficient
(n-octanol/
water), Generator Column Method.
Partition
Coefficient
(n-octanol/
water), Estimation by Liquid Chromatography.
Water Solubility: Column Elution
Method, Shake Flask Method.
Water Solubility, Generator Column
Method.
Vapor Pressure ................................
3/04/2015
870.1100 ........
Acute Oral Toxicity ...........................
3/04/2015
870.1200 ........
Acute Dermal Toxicity ......................
3/04/2015
870.1300 ........
Acute Inhalation Toxicity ..................
3/04/2015
870.2500 ........
Acute Dermal Irritation .....................
3/04/2015
870.2600 ........
Skin Sensitization .............................
3/04/2015
870.2400 ........
Acute Eye Irritation ...........................
3/04/2015
810.2100 ........
Sterilants ...........................................
3/04/2015
810.2200 ........
Disinfectants for Use on Hard Surfaces.
Sanitizers for Use on Hard Surfaces
3/04/2015
830.7560 ........
830.7570 ........
830.7840 ........
830.7860 ........
810.2300 ........
810.2400 ........
Date EPA
issued DCI
3/04/2015
3/04/2015
3/04/2015
3/04/2015
3/04/2015
810.2500 ........
Disinfectants and Sanitizers for Use
on Fabrics and Textiles.
Air Sanitizers ....................................
3/04/2015
3/04/2015
810.2600 ........
Disinfectants for Use in Water .........
3/04/2015
Date registrant received DCI
Final data
due date
Reason for
notice of
intent to
suspend *
Confirmation
ence.
Confirmation
ence.
Confirmation
ence.
Confirmation
ence.
Confirmation
ence.
Confirmation
ence.
through Correspond-
11/02/2015
1&3
through Correspond-
11/02/2015
1&3
through Correspond-
11/02/2015
1&3
through Correspond-
11/02/2015
1&3
through Correspond-
11/02/2015
1&3
through Correspond-
11/02/2015
1&3
Confirmation
ence.
Confirmation
ence.
Confirmation
ence.
Confirmation
ence.
Confirmation
ence.
Confirmation
ence.
Confirmation
ence.
Confirmation
ence.
Confirmation
ence.
Confirmation
ence.
Confirmation
ence.
Confirmation
ence.
Confirmation
ence.
Confirmation
ence.
Confirmation
ence.
through Correspond-
11/02/2015
1&3
through Correspond-
11/02/2015
1&3
through Correspond-
11/02/2015
1&3
through Correspond-
11/02/2015
1&3
through Correspond-
11/02/2015
1&3
through Correspond-
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through Correspond-
11/02/2015
1&3
through Correspond-
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1&3
through Correspond-
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1&3
through Correspond-
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1&3
through Correspond-
11/02/2015
1&3
through Correspond-
11/02/2015
1&3
through Correspond-
11/02/2015
1&3
through Correspond-
11/02/2015
1&3
through Correspond-
11/02/2015
1&3
* Table Notes:
1 No 90-day response received.
2 Inadequate 90-day response received.
3 No data received.
4 Inadequate data received.
IV. Attachment III Suspension Report—
Explanatory Appendix
jbell on DSKJLSW7X2PROD with NOTICES
1. The letter sent to the registrant
contains an Attachment III—
Explanatory Appendix. This
Explanatory Appendix also follows
below and provides provides a
discussion of the basis for the Notice of
Intent to Suspend issued herewith.
A. Aklyl Dimethyl Benzyl Ammonium
Chloride (ADBAC)
On March 4, 2015, March 6, 2015, and
March 11, 2015, the Agency issued the
Reregistration Eligibility Decision
Document (RED) PDCI Notices
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numbered: 069184–30960, 069137–
30946, 069119–30941, and 069104–
30932 pursuant to FIFRA section
4(g)(2)(B), which required the registrants
of products containing ADBAC used as
an active ingredient to develop and
submit certain data. The data/
information were determined to be
necessary to satisfy the reregistration
requirements of FIFRA section 4(g).
Failure to comply with the requirements
of the RED PDCI is a basis for
suspension under FIFRA section
3(c)(2)(B).
The Agency sent PDCIs: 069184–
30960, 069137–30946, 069119–30941,
and 069104–30932 on March 4, 6, and
PO 00000
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11, 2015 to Qualco, Inc. via the email
address provided to the Agency for Ms.
Debbie Schaub, who was the designated
company representative. A Microsoft
Outlook server response email for PDCI–
069104–30932 was received on March
11, 2015 by the Agency to indicate
delivery to Ms. Schaub was complete.
Subsequently, the PDCIs were re-sent on
March 27, 2015 to an alternative Qualco,
Inc. email address for Ms. Schaub
because no response was received after
email delivery to the original email
address.
Following a DCI issuance, registrants
are required to submit a 90-day response
electing how they will satisfy the DCI
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data requirements. Qualco, Inc. failed to
submit a 90-day response electing how
it would satisfy the DCI data
requirements.
After three years of no response from
Qualco, Inc. on May 21, 2018, the
Agency sent emails to Qualco, Inc. to
the attention of Ms. Schaub and Mr.
Peter Ferentinos, who is another
designated Qualco, Inc. representative.
In the emails, the Agency discussed the
severity of the PDCI response failures by
Qualco, Inc. These emails also
forwarded once again the originally sent
PDCIs and email with attachments and
instructions. The Agency received
Microsoft Outlook server response
emails for each PDCI (069184–30960,
069137–30946, 069119–30941, and
069104–30932) email that confirmed
that delivery to both addresses had been
completed on May 21, 2018.
After hearing nothing from Qualco
between May 21 and October 31, 2018
the Agency emailed a Notification of
Deficiency letter to Qualco, Inc. on
October 31, 2018 to the attention of Ms.
Schaub that warned the registrant of the
pending suspension of the affected
Qualco, Inc. ADBAC products. The
email listed the overdue PDCIs and the
attached letter noted the specific
deficient data requirements for each
listed PDCI, discussed the lack of an
adequate 90-day response for each PDCI,
described how to respond to the
deficiency letter, included the list of
then affected (EPA Reg. Nos.: 3525–22,
3525–78, 3525–90, 3525–92, 3525–94,
3525–97, 3525–99, 3525–100, 3525–103,
3525–104, 3525–106, and 3525–118),
and stated that appropriate and
adequate data to satisfy the overdue data
requirements must be received by the
Agency within 10 business days
measured from the letter receipt by
Qualco, Inc. in order to avoid issuance
of Notices of Intent to Suspend. The
Agency received a Microsoft Outlook
server email on October 31, 2018
indicating that the email and the
attached information had been received
by Qualco, Inc. on October 31, 2018.
The same October 31, 2018
Notification of Deficiency letter was
mailed via the US Postal Service on
November 8, 2018 along with another
Notification of Deficiency letter for
another chemical case (Busan 77).
The Agency subsequently sent
Qualco, Inc. an email to the attention of
Ms. Schaub on November 20, 2018
stating that a voicemail had been left for
Ms. Schaub. The November 20, 2018
email and voicemail both requested a
meeting to discuss the ADBAC and
Busan 77 DCIs. The Agency proposed
meeting dates and times in the
November 20, 2018 email. The
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17:33 Sep 01, 2020
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November 20, 2018 email included the
October 31, 2018 email discussed above
as part of its chain of prior
correspondence.
Ms. Schaub responded by email to the
Agency’s November 20, 2018 email on
November 26, 2018. The Agency’s
October 31, 2018 email with the initial
Notification of Deficiency warning letter
was included in the chain of emails that
were part of her email response. Qualco,
Inc., through Ms. Schaub, suggested
scheduling a November 28, 2018
meeting in her November 26, 2018
email.
An Agency email response was sent to
Ms. Schaub on November 26, 2018
confirming the scheduling of a
November 28, 2018 teleconference
meeting at 1 p.m. On November 28,
2018 the Agency and Ms. Schaub met
via teleconference to discuss the
overdue data requirements of PDCIs:
069104–30932, 069119–30941, 069137–
30946, 069184–30960, and the affected
Qualco products (EPA Reg. Nos.: 3525–
22, 3525–78, 3525–90, 3525–92, 3525–
94, 3525–97, 3525–99, 3525–100, 3525–
103, 3525–104, 3525–106, and 3525–
118).
Ms. Schaub subsequently sent the
Agency an email on December 3, 2018
to inform the Chemical Review Manager
that a DCI response was being put
together for ADBAC, that errors were
received after an attempt to upload files
to the EPA CDX, and to ask what other
specific forms were required for the
PDCI response.
The Agency responded by email on
December 3, 2018 and attached another
copy of the PDCI–069104–30932 for Ms.
Schaub’s reference. This PDCI was
attached as a representative DCI to
illustrate what needed to be done by
Qualco to adequately respond to all
issued PDCIs. The Agency once again
stated that instructions and required
forms for Qualco’s response are
explained in the PDCI. The CDX
helpdesk contact information was
provided for Ms. Schaub’s reference.
However, the Agency requested that
Qualco’s responses be sent directly by
email to the Chemical Review Manager
to avoid CDX errors or the product
suspension process would continue. In
the Agency December 3, 2018 email, a
list of all the affected Qualco products
pending suspension (EPA Reg. Nos.:
3525–22, 3525–78, 3525–94, 3525–97,
3525–99, 3525–100, 3525–103, 3525–
104, 3525–106, and 3525–118) was
attached. The December 3, 2018 email
also noted that two products (3525–90
and 3525–92) originally listed in the
October 31, 2018 letter had been
voluntarily cancelled.
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Ms. Schaub responded to the
Agency’s December 3, 2018 email chain
by providing attachments, including
data matrices, Confidential Statement of
Formulas (CSF), and other forms, for 5
of the 10 products pending suspension
(EPA Reg. Nos.: 3525–22, 3525–78,
3525–94, 3525–106, and 3525–118). Ms.
Schaub stated in the December 3, 2018
email that additional forms and
responses for the other 5 products (EPA
Reg. Nos.: 3525–103, 3525–104, 3525–
97, 3525–99, and 3525–100) would be
submitted through a second CDX
attempt.
On December 4, 2018 the Agency
stated through email that the submitted
ADBAC PDCI responses would be
reviewed. The Agency requested that
Ms. Schaub submit the remaining
responses and suggested that, if some
products are dormant, then Qualco may
opt to voluntarily cancel those products.
On December 5, 2018, an email from
the CDX system to the EPA
Antimicrobials Divison Reevaluation
mailbox was received. The December 5,
2018 CDX email indicated that a DCI
response for only PDCI–069137–30946
had been submitted and included data
matrices, citation forms, and
correspondence for only EPA
Registration Nos.: 3525–100, 3525–103,
3525–97, and 3525–99. No submissions
were provided for EPA registration
number 3525–104 by email or CDX.
The Agency sent an email on
December 5, 2018 to Ms. Schaub
informing Qualco that the emailed
submissions were reviewed but
numerous errors were found. The
Agency’s December 5, 2018 email
requested that corrected responses be
sent as soon as possible. The following
list summarizes the errors.
• The ‘‘Requirements Status &
Registrant’s Response’’ forms listed
response code 9; however, this code
does not exist for PDCI responses and is
not an adequate or appropriate
response. This error pertains to the
following products: EPA Reg. Nos.:
3525–22, 3525–78, 3525–94, 3525–106,
and 3525–118.
• The ‘‘Requirements Status &
Registrant’s Response’’ forms were not
adequately completed. This error
pertains to the following products: EPA
Reg. Nos.: 3525–97, 3525–99, 3525–100,
and 3525–103.
• The data matrices submitted for
EPA Reg. Nos.: 3525–22, 3525–78,
3525–94, 3525–97, 3525–99, 3525–100,
3525–103, and 3525–106 are missing
anything to address the 810 data
requirements.
• The Formulator’s Exemption form
for EPA Reg. No.: 3525–118 states that
the product’s source is EPA Reg. No.
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3525–118, which is stating that the
product is formulated with itself and
this is neither an adequate nor
appropriate response.
• Qualco, Inc. chose the option to cite
another registrant’s study for product
specific data for the following products:
EPA Reg. Nos.: 3525–22, 3525–78,
3525–97, 3525–99, 3525–100, 3525–103,
and 3525–106. However, Qualco did not
provide the appropriate MRID
Accession number(s) or an adequately
completed ‘‘Certification with Respect
to Data Compensation Requirements’’
form. The submitted ‘‘Certification with
Respect to Citation of Data’’ forms
cannot state ‘‘cite all’’ for PDCIs unless
the ‘‘Certification with Respect to Data
Compensation’’ form is submitted with
the appropriate MRID Accession
number(s).
Qualco, Inc. has not responded to the
Agency’s December 5, 2018 email and
has not to-date satisfied the overdue
PDCI requirements for its affected
products. Therefore, this Notice of
Intent to Suspend is being issued for
EPA Registration Nos.: 3525–22, 3525–
78, 3525–94, 3525–97, 3525–99, 3525–
100, 3525–103, 3525–104, 3525–106,
and 3525–118.
V. How to avoid suspension under this
notice?
1. You may avoid suspension under
this notice if you or another person
adversely affected by this notice
properly request a hearing within 30
days of your receipt of the Notice of
Intent to Suspend by mail or, if you did
not receive the notice that was sent to
you via USPS first class mail return
receipt requested, then within 30 days
from the date of publication of this
Federal Register notice (see DATES). If
you request a hearing, it will be
conducted in accordance with the
requirements of FIFRA section 6(d) (7
U.S.C. 136d) and the Agency’s
procedural regulations in 40 CFR part
164. Section 3(c)(2)(B) of FIFRA (7
U.S.C. 136a), however, provides that the
only allowable issues which may be
addressed at the hearing are whether
you have failed to take the actions
which are the bases of this notice and
whether the Agency’s decision
regarding the disposition of existing
stocks is consistent with FIFRA.
Therefore, no substantive allegation or
legal argument concerning other issues,
including but not limited to the
Agency’s original decision to require the
submission of data or other information,
the need for or utility of any of the
required data or other information or
deadlines imposed, any allegations of
errors or unfairness in any proceedings
before an arbitrator, and the risks and
VerDate Sep<11>2014
17:33 Sep 01, 2020
Jkt 250001
benefits associated with continued
registration of the affected product, may
be considered in the proceeding. The
Administrative Law Judge shall by order
dismiss any objections which have no
bearing on the allowable issues which
may be considered in the proceeding.
Section 3(c)(2)(B)(iv) of FIFRA provides
that any hearing must be held and a
determination issued within 75 days
after receipt of a hearing request. This
75-day period may not be extended
unless all parties in the proceeding
stipulate to such an extension. If a
hearing is properly requested, the
Agency will issue a final order at the
conclusion of the hearing governing the
suspension of your products. A request
for a hearing pursuant to this notice
must:
• Include specific objections which
pertain to the allowable issues which
may be heard at the hearing.
• Identify the registrations for which
a hearing is requested.
• Set forth all necessary supporting
facts pertaining to any of the objections
which you have identified in your
request for a hearing.
If a hearing is requested by any person
other than the registrant, that person
must also state specifically why he/she
asserts that he/she would be adversely
affected by the suspension action
described in this notice. Three copies of
the request must be submitted to:
Hearing Clerk, 1900, Environmental
Protection Agency, 1200 Pennsylvania
Ave. NW, Washington, DC 20460–0001.
An additional copy should be sent to
the person who signed this notice. The
request must be received by the Hearing
Clerk by the applicable 30th day
deadline as measured from your receipt
of the Notice of Intent to Suspend by
mail or publication of this notice, as set
forth in DATES and in Unit IV.1., in order
to be legally effective. The 30-day time
limit is established by FIFRA and
cannot be extended for any reason.
Failure to meet the 30-day time limit
will result in automatic suspension of
your registrations by operation of law
and, under such circumstances, the
suspension of the registration for your
affected products will be final and
effective at the close of business on the
applicable 30th day deadline as
measured from your receipt of the
Notice of Intent to Suspend by mail or
publication of this notice, as set forth in
DATES and in Unit IV.1., and will not be
subject to further administrative review.
The Agency’s rules of practice at 40 CFR
164.7 forbid anyone who may take part
in deciding this case, at any stage of the
proceeding, from discussing the merits
of the proceeding ex parte with any
party or with any person who has been
PO 00000
Frm 00040
Fmt 4703
Sfmt 4703
54571
connected with the preparation or
presentation of the proceeding as an
advocate or in any investigative or
expert capacity, or with any of their
representatives. Accordingly, the
following EPA offices, and the staffs
thereof, are designated as judicial staff
to perform the judicial function of EPA
in any administrative hearings on this
Notice of Intent to Suspend: The Office
of the Administrative Law Judges, the
Office of the Environmental Appeals
Board, the EPA Administrator, the EPA
Deputy Administrator, and the members
of the staff in the immediate offices of
the EPA Administrator and EPA Deputy
Administrator. None of the persons
designated as the judicial staff shall
have any ex parte communication with
trial staff or any other interested person
not employed by EPA on the merits of
any of the issues involved in this
proceeding, without fully complying
with the applicable regulations.
2. You may also avoid suspension if,
within the applicable 30-day deadline
period as measured from your receipt of
the Notice of Intent to Suspend by mail
or publication of this notice, as set forth
in DATES and in Unit IV.1., the Agency
determines that you have taken
appropriate steps to comply with the
FIFRA section 3(c)(2)(B) DCI notice. In
order to avoid suspension under this
option, you must satisfactorily comply
with Table 2.—List of Requirements in
Unit II., for each product by submitting
all required supporting data/information
described in Table 2 of Unit. II. and in
the Explanatory Appendix (in the
docket for this Federal Register notice)
to the following address (preferably by
certified mail):
Office of Pesticide Programs,
Antimicrobials Division (7510P),
Environmental Protection Agency, 1200
Pennsylvania Ave. NW, Washington, DC
20460–0001.
For you to avoid automatic
suspension under this notice, the
Agency must also determine within the
applicable 30-day deadline period that
you have satisfied the requirements that
are the bases of this notice and so notify
you in writing. You should submit the
necessary data/information as quickly as
possible for there to be any chance the
Agency will be able to make the
necessary determination in time to
avoid suspension of your products. The
suspension of the registrations of your
company’s products pursuant to this
notice will be rescinded when the
Agency determines you have complied
fully with the requirements which were
the bases of this notice. Such
E:\FR\FM\02SEN1.SGM
02SEN1
54572
Federal Register / Vol. 85, No. 171 / Wednesday, September 2, 2020 / Notices
Dated: August 19, 2020.
Anita Pease,
Director, Antimicrobials Division, Office of
Pesticide Programs.
compliance may only be achieved by
submission of the data/information
described in Table 2 of Unit II.
jbell on DSKJLSW7X2PROD with NOTICES
VI. Status of Products That Become
Suspended
[FR Doc. 2020–19370 Filed 9–1–20; 8:45 am]
BILLING CODE 6560–50–P
Your product will remain suspended,
however, until the Agency determines
you are in compliance with the
requirements which are the bases of this
notice and so informs you in writing.
After the suspension becomes final
and effective, the registrants subject to
this notice, including all supplemental
registrants of products listed in Table 1
of Unit II., may not legally distribute,
sell, use, offer for sale, hold for sale,
ship, deliver for shipment, or receive
and (having so received) deliver or offer
to deliver, to any person, the products
listed in Table 1 of Unit II. Persons other
than the registrants subject to this
notice, as defined in the preceding
sentence, may continue to distribute,
sell, use, offer for sale, hold for sale,
ship, deliver for shipment, or receive
and (having so received) deliver or offer
to deliver, to any person, the products
listed in Table 1 of Unit II. Nothing in
this notice authorizes any person to
distribute, sell, use, offer for sale, hold
for sale, ship, deliver for shipment, or
receive and (having so received) deliver
or offer to deliver, to any person, the
products listed in Table 1 of Unit II. in
any manner which would have been
unlawful prior to the suspension.
If the registrations for your products,
listed in Table 1 of Unit II., are currently
suspended as a result of failure to
comply with another FIFRA section
3(c)(2)(B) DCI notice or FIFRA Section
4 Data Requirements notice, this notice,
when it becomes a final and effective
order of suspension, will be in addition
to any existing suspension, i.e., all
requirements which are the bases of the
suspension must be satisfied before the
registration will be reinstated.
It is the responsibility of the basic
registrant to notify all supplementary
registered distributors of a basic
registered product that this suspension
action also applies to their
supplementary registered products. The
basic registrant may be held liable for
violations committed by their
distributors.
Any questions about the requirements
and procedures set forth in this notice
or in the subject FIFRA section
3(c)(2)(B) DCI notice, should be
addressed to the person listed under FOR
FURTHER INFORMATION CONTACT.
(Authority: 7 U.S.C. 136 et seq.)
VerDate Sep<11>2014
17:33 Sep 01, 2020
Jkt 250001
ENVIRONMENTAL PROTECTION
AGENCY
[EPA–HQ–OPP–2017–0750; FRL–10012–60]
Pesticide Registration Review;
Proposed Interim Decisions for Several
Pesticides; Notice of Availability
Environmental Protection
Agency (EPA).
ACTION: Notice.
AGENCY:
This notice announces the
availability of EPA’s proposed interim
registration review decisions and opens
a 60-day public comment period on the
proposed interim decisions for the
following pesticides: 1, 4Dimethylnapthalene and 2,6Diisopropylnaphthalene, acequinocyl,
Bacillus cereus strain BP01,
cypermethrins, dithiopyr, etridiazole,
fenamidone, fenbutatin-oxide,
fenpropimorph, fenpyroximate,
flonicamid, flumetralin, flumioxazin,
hypochlorous acid, inorganic halides,
MCPB, Metarhizium anisopliae,
metolachlor/S-metolachlor, Pantoea
agglomerans strain C9–1, Pantoea
agglomerans strain E325, propanil,
terbacil, triclopyr.
DATES: Comments must be received on
or before November 2, 2020.
ADDRESSES: Submit your comments,
identified by the docket identification
(ID) number for the specific pesticide of
interest provided in the Table in Unit
IV, by one of the following methods:
• Federal eRulemaking Portal: https://
www.regulations.gov. Follow the online
instructions for submitting comments.
Do not submit electronically any
information you consider to be
Confidential Business Information (CBI)
or other information whose disclosure is
restricted by statute.
• Mail: OPP Docket, Environmental
Protection Agency Docket Center (EPA/
DC), (28221T), 1200 Pennsylvania Ave.
NW, Washington, DC 20460–0001.
• Hand Delivery: To make special
arrangements for hand delivery or
delivery of boxed information, please
follow the instructions at https://
www.epa.gov/dockets/contacts.html.
Please note that due to the public
health emergency the EPA Docket
Center (EPA/DC) and Reading Room
was closed to public visitors on March
31, 2020. Our EPA/DC staff will
SUMMARY:
PO 00000
Frm 00041
Fmt 4703
Sfmt 4703
continue to provide customer service
via email, phone, and webform. For
further information on EPA/DC services,
docket contact information and the
current status of the EPA/DC and
Reading Room, please visit https://
www.epa.gov/dockets.
FOR FURTHER INFORMATION CONTACT: For
pesticide specific information, contact:
The Chemical Review Manager for the
pesticide of interest identified in the
Table in Unit IV.
For general information on the
registration review program, contact:
Melanie Biscoe, Pesticide Re-Evaluation
Division (7508P), Office of Pesticide
Programs, Environmental Protection
Agency, 1200 Pennsylvania Ave. NW,
Washington, DC 20460–0001; telephone
number: (703) 305–7106; email address:
biscoe.melanie@epa.gov.
SUPPLEMENTARY INFORMATION:
I. General Information
A. Does this action apply to me?
This action is directed to the public
in general and may be of interest to a
wide range of stakeholders including
environmental, human health, farm
worker, and agricultural advocates; the
chemical industry; pesticide users; and
members of the public interested in the
sale, distribution, or use of pesticides.
Since others also may be interested, the
Agency has not attempted to describe all
the specific entities that may be affected
by this action. If you have any questions
regarding the applicability of this action
to a particular entity, consult the
Chemical Review Manager for the
pesticide of interest identified in the
Table in Unit IV.
B. What should I consider as I prepare
my comments for EPA?
1. Submitting CBI. Do not submit this
information to EPA through
regulations.gov or email. Clearly mark
the part or all of the information that
you claim to be CBI. For CBI
information on a disk or CD–ROM that
you mail to EPA, mark the outside of the
disk or CD–ROM as CBI and then
identify electronically within the disk or
CD–ROM the specific information that
is claimed as CBI. In addition to one
complete version of the comment that
includes information claimed as CBI, a
copy of the comment that does not
contain the information claimed as CBI
must be submitted for inclusion in the
public docket. Information so marked
will not be disclosed except in
accordance with procedures set forth in
40 CFR part 2.
2. Tips for preparing your comments.
When preparing and submitting your
comments, see the commenting tips at
E:\FR\FM\02SEN1.SGM
02SEN1
]]>Agencies
[Federal Register Volume 85, Number 171 (Wednesday, September 2, 2020)]
[Notices]
[Pages 54563-54572]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-19370]
-----------------------------------------------------------------------
ENVIRONMENTAL PROTECTION AGENCY
[EPA-HQ-OPP-2019-0565; FRL-10003-30]
Notice of Intent To Suspend Certain Pesticide Registrations
AGENCY: Environmental Protection Agency (EPA).
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: This notice, pursuant the Federal Insecticide, Fungicide and
[[Page 54564]]
Rodenticide Act (FIFRA), publishes a Notice of Intent to Suspend
certain pesticide registrations issued by EPA. The Notice of Intent to
Suspend was issued following the Agency's issuance of a Data Call-In
Notice (DCI), which required the registrant of the affected pesticide
products containing a certain pesticide active ingredient to take
appropriate steps to secure certain data, and following the
registrant's failure to submit these data or to take other appropriate
steps to secure the required data. The subject data were determined to
be required to maintain in effect the existing registrations of the
affected products. Failure to comply with the data requirements of a
DCI is a basis for suspension of the affected registrations under
FIFRA.
DATES: The Notice of Intent to Suspend included in this Federal
Register notice will become a final and effective suspension order
automatically by operation of law 30 days after the date of the
registrant's receipt of the mailed Notice of Intent to Suspend or, if
the mailed Notice of Intent to Suspend is returned to the EPA
Administrator as undeliverable, if delivery is refused, or if the EPA
Administrator otherwise is unable to accomplish delivery to the
registrant after making reasonable efforts to do so, the Notice of
Intent to Suspend becomes effective 30 days after the date of
publication of this notice in the Federal Register, unless, during that
time, a timely and adequate request for a hearing is made by a person
adversely affected by the Notice of Intent to Suspend, or the
registrant has satisfied the EPA Administrator that the registrant has
complied fully with the requirements that served as a basis for the
Notice of Intent to Suspend. Unit IV. explains what must be done to
avoid suspension under this notice (i.e., how to request a hearing or
how to comply fully with the requirements that served as a basis for
the Notice of Intent to Suspend).
FOR FURTHER INFORMATION CONTACT: Erin Dandridge, Antimicrobial Division
(7510P), Office of Pesticide Programs, Environmental Protection Agency,
1200 Pennsylvania Ave. NW, Washington, DC 20460-0001, telephone number:
(703) 347-0185, email: [email protected].
SUPPLEMENTARY INFORMATION:
I. General Information
A. Does this action apply to me?
This action is directed to the public in general and may be of
interest to a wide range of stakeholders including environmental, human
health, farm worker and agricultural advocates; the chemical industry;
pesticide users; and members of the public interested in the sale,
distribution, or use of pesticides. Since others also may be
interested, the Agency has not attempted to describe all the specific
entities that may be affected by this action.
B. How can I get copies of this document and other related information?
The docket for this action, identified by docket identification
(ID) number EPA-HQ-OPP-2019-0565, is available at https://www.regulations.gov or at the Office of Pesticide Programs Regulatory
Public Docket (OPP Docket) in the Environmental Protection Agency
Docket Center (EPA/DC), William Jefferson Clinton West Building., Room.
3334, 1301 Constitution Ave. NW, Washington, DC 20460-0001. The Public
Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through
Friday, excluding legal holidays. The telephone number for the Public
Reading Room is (202) 566-1744, and the telephone number for the OPP
Docket is (703) 305-5805. Please review the visitor instructions and
additional information about the docket available at https://www.epa.gov/dockets.
II. Registrant Issued Notice of Intent To Suspend Active Ingredient,
Product(s) Affected, and Date(s) Issued
The registrant and products subject to this Notice of Intent to
Suspend are listed in Table 1. A Notice of Intent to Suspend was sent
to the registrant of the affected products via the U.S. Postal Service,
first class mail, return receipt requested.
Table 1--List of Registrant and Products Subject to Suspension
----------------------------------------------------------------------------------------------------------------
EPA registration Date EPA issued notice
Registrant affected Active ingredient No. Product name of intent to suspend
----------------------------------------------------------------------------------------------------------------
Qualco, Inc.............. Dialkyl*methyl benzyl 3525-22 Utikem Algaesan July 27, 2020.
ammonium chloride Multi-Purpose
*(60%C14, 30% C16, Algaecide.
5% C18, 5% C12).
Qualco, Inc.............. Dialkyl*methyl benzyl 3525-78 Algae Destroyer. July 27, 2020.
ammonium chloride
*(60%C14, 30% C16,
5% C18, 5% C12).
Qualco, Inc.............. Alkyl*dimethyl benzyl 3525-94 Coastal Pool Aid July 27, 2020.
ammonium chloride* Powder Surface
(60%C14, 30%C16, Sanitizer.
5%C18, 5%C12).
Qualco, Inc.............. Alkyl* dimethyl 3525-97 Winter Aid...... July 27, 2020.
benzyl ammonium
chloride *(60%C14,
25%C12, 15%C16).
Qualco, Inc.............. Alkyl* dimethyl 3525-99 Coastal Pool July 27, 2020.
benzyl ammonium Deodor.
chloride *(60%C14,
25%C12, 15%C16).
Qualco, Inc.............. Alkyl* dimethyl 3525-100 Winter Tablets July 27, 2020.
benzyl ammonium ``G''.
chloride *(60%C14,
25%C12, 15%C16).
Qualco, Inc.............. Alkyl* dimethyl 3525-103 Cal Jet July 27, 2020.
benzyl ammonium Algaecide
chloride *(60%C14, Liquid.
25%C12, 15%C16).
Qualco, Inc.............. Alkyl* dimethyl 3525-104 Iso Clor ``C'' July 27, 2020.
benzyl ammonium Super
chloride *(95%C14, Stabilized
3%C12, 2%C16). Chlorinating
Powder.
Qualco, Inc.............. Dialkyl*methyl benzyl 3525-106 Liquid Algaecide July 27, 2020.
ammonium chloride
*(60%C14, 30% C16,
5% C18, 5% C12).
[[Page 54565]]
Qualco, Inc.............. Dialkyl*methyl benzyl 3525-118 Coastal July 27, 2020.
ammonium chloride Concentrate 50.
*(60%C14, 30% C16,
5% C18, 5% C12).
----------------------------------------------------------------------------------------------------------------
III. Basis for Issuance of Notice of Intent To Suspend; Requirement
List
The registrant failed to submit the data or information required by
the Data Call-In Notice, or to take other appropriate steps to secure
the required data for their pesticide products listed in Table 2 of
this unit.
While the Agency did not receive a certified mail return receipt
from Ms. Schaub, the agent for Qualco, Inc., or from Qualco, Inc. for
the Product Specific Data Call-In (PDCI) Notice requiring data
generation and submission for EPA Reg. Nos. 3525-22, 3525-78, 3525-94,
3524-97, 3525-99, 3525-100, 3525-103, 3525-104, 3525-106, and 3525-118,
the agency has correspondence from the company's representative after
the PDCI Notices were issued evidencing that Ms. Schaub and thus
Qualco, Inc. received the PDCIs and were aware of the data
requirements.
Table 2-A--List of Requirements for EPA Registration Number 3525-94
----------------------------------------------------------------------------------------------------------------
Reason for
Guideline No. as Date EPA Date registrant Final data due notice of
listed in applicable Requirement name issued DCI received DCI date intent to
DCI suspend *
----------------------------------------------------------------------------------------------------------------
830.1550.............. Product Identity 3/11/2015 Confirmation 11/09/2015 2 & 4
and Composition. through
Correspondence.
830.1600.............. Description of 3/11/2015 Confirmation 11/09/2015 2 & 4
Materials Used to through
Produce the Correspondence.
Product.
830.1620.............. Description of 3/11/2015 Confirmation 11/09/2015 2 & 4
Production Process. through
Correspondence.
830.1650.............. Description of 3/11/2015 Confirmation 11/09/2015 2 & 4
Formulation through
Process. Correspondence.
830.1670.............. Discussion of 3/11/2015 Confirmation 11/09/2015 2 & 4
Formation of through
Impurities. Correspondence.
830.1700.............. Preliminary 3/11/2015 Confirmation 11/09/2015 2 & 4
Analysis. through
Correspondence.
830.1750.............. Certified Limits... 3/11/2015 Confirmation 11/09/2015 2 & 4
through
Correspondence.
830.1800.............. Enforcement 3/11/2015 Confirmation 11/09/2015 2 & 4
Analytical Method. through
Correspondence.
830.6302.............. Color.............. 3/11/2015 Confirmation 11/09/2015 2 & 4
through
Correspondence.
830.6303.............. Physical State..... 3/11/2015 Confirmation 11/09/2015 2 & 4
through
Correspondence.
830.6304.............. Odor............... 3/11/2015 Confirmation 11/09/2015 2 & 4
through
Correspondence.
830.6313.............. Stability to Normal 3/11/2015 Confirmation 11/09/2015 2 & 4
and Elevated through
Temperatures,Metal Correspondence.
s, and Metal.
830.6314.............. Oxidizing or 3/11/2015 Confirmation 11/09/2015 2 & 4
Reducing Action. through
Correspondence.
830.6315.............. Flammability....... 3/11/2015 Confirmation 11/09/2015 2 & 4
through
Correspondence.
830.6316.............. Explodability...... 3/11/2015 Confirmation 11/09/2015 2 & 4
through
Correspondence.
830.6317.............. Storage Stability.. 3/11/2015 Confirmation 07/09/2016 2 & 4
through
Correspondence.
830.6319.............. Miscibility........ 3/11/2015 Confirmation 11/09/2015 2 & 4
through
Correspondence.
830.6320.............. Corrosion 3/11/2015 Confirmation 07/09/2016 2 & 4
Characteristics. through
Correspondence.
830.6321.............. Dielectric 3/11/2015 Confirmation 11/09/2015 2 & 4
Breakdown Voltage. through
Correspondence.
830.7000.............. pH................. 3/11/2015 Confirmation 11/09/2015 2 & 4
through
Correspondence.
830.7050.............. UV/Visible 3/11/2015 Confirmation 11/09/2015 2 & 4
Absorption. through
Correspondence.
830.7100.............. Viscosity.......... 3/11/2015 Confirmation 11/09/2015 2 & 4
through
Correspondence.
830.7200.............. Melting Point/ 3/11/2015 Confirmation 11/09/2015 2 & 4
Melting Range. through
Correspondence.
830.7220.............. Boiling Point/ 3/11/2015 Confirmation 11/09/2015 2 & 4
Boiling Range. through
Correspondence.
[[Page 54566]]
830.7300.............. Density/Relative 3/11/2015 Confirmation 11/09/2015 2 & 4
Density. through
Correspondence.
830.7370.............. Dissociation 3/11/2015 Confirmation 11/09/2015 2 & 4
Constants in Water. through
Correspondence.
830.7550.............. Partition 3/11/2015 Confirmation 11/09/2015 2 & 4
Coefficient (n- through
octanol/water), Correspondence.
Shake Flask Method.
830.7560.............. Partition 3/11/2015 Confirmation 11/09/2015 2 & 4
Coefficient (n- through
octanol/water, Correspondence.
Generator Column
Method.
830.7570.............. Partition 3/11/2015 Confirmation 11/09/2015 2 & 4
Coefficient (n- through
octanol/water, Correspondence.
Estimation by
Liquid
Chromatography.
830.7840.............. Water Solubility: 3/11/2015 Confirmation 11/09/2015 2 & 4
Column Elution through
Method, Shake Correspondence.
Flask Method.
830.7860.............. Water Solubility, 3/11/2015 Confirmation 11/09/2015 2 & 4
Generator Column through
Method. Correspondence.
830. 7950............. Vapor Pressure..... 3/11/2015 Confirmation 11/09/2015 2 & 4
through
Correspondence.
870.1100.............. Acute Oral Toxicity 3/11/2015 Confirmation 11/09/2015 2 & 4
through
Correspondence.
870.1200.............. Acute Dermal 3/11/2015 Confirmation 11/09/2015 2 & 4
Toxicity. through
Correspondence.
870.1300.............. Acute Inhalation 3/11/2015 Confirmation 11/09/2015 2 & 4
Toxicity. through
Correspondence.
870.2500.............. Acute Dermal 3/11/2015 Confirmation 11/09/2015 2 & 4
Irritation. through
Correspondence.
870.2600.............. Skin Sensitization. 3/11/2015 Confirmation 11/09/2015 2 & 4
through
Correspondence.
870.2400.............. Acute Eye 3/11/2015 Confirmation 11/09/2015 2 & 4
Irritation. through
Correspondence.
810.2100.............. Sterilants......... 3/11/2015 Confirmation 11/09/2015 2 & 4
through
Correspondence.
810.2200.............. Disinfectants for 3/11/2015 Confirmation 11/09/2015 2 & 4
Use on Hard through
Surfaces. Correspondence.
810.2300.............. Sanitizers for Use 3/11/2015 Confirmation 11/09/2015 2 & 4
on Hard Surfaces. through
Correspondence.
810.2400.............. Disinfectants and 3/11/2015 Confirmation 11/09/2015 2 & 4
Sanitizers for Use through
on Fabrics and Correspondence.
Textiles.
810.2500.............. Air Sanitizers..... 3/11/2015 Confirmation 11/09/2015 2 & 4
through
Correspondence.
810.2600.............. Disinfectants for 3/11/2015 Confirmation 11/09/2015 2 & 4
Use in Water. through
Correspondence.
----------------------------------------------------------------------------------------------------------------
* Table Notes:
\1\ No 90-day response received.
\2\ Inadequate 90-day response received.
\3\ No data received.
\4\ Inadequate data received.
Table 2-B--List of Requirements for EPA Registration Numbers: 3525-22; 3525-78; 3525-97; 3525-99; 3525-100; 3525-
103; 3525-106; and 3525-118
----------------------------------------------------------------------------------------------------------------
Reason for
Guideline No. as Date EPA Date registrant Final data due notice of
listed in applicable Requirement name issued DCI received DCI date intent to
DCI suspend *
----------------------------------------------------------------------------------------------------------------
830.1550.............. Product Identity 3/06/2015 Confirmation 11/04/2015 2 & 4
and Composition. through
Correspondence.
830.1600.............. Description of 3/06/2015 Confirmation 11/04/2015 2 & 4
Materials Used to through
Produce the Correspondence.
Product.
830.1620.............. Description of 3/06/2015 Confirmation 11/04/2015 2 & 4
Production Process. through
Correspondence.
830.1650.............. Description of 3/06/2015 Confirmation 11/04/2015 2 & 4
Formulation through
Process. Correspondence.
830.1670.............. Discussion of 3/06/2015 Confirmation 11/04/2015 2 & 4
Formation of through
Impurities. Correspondence.
830.1700.............. Preliminary 3/06/2015 Confirmation 11/04/2015 2 & 4
Analysis. through
Correspondence.
830.1750.............. Certified Limits... 3/06/2015 Confirmation 11/04/2015 2 & 4
through
Correspondence.
[[Page 54567]]
830.1800.............. Enforcement 3/06/2015 Confirmation 11/04/2015 2 & 4
Analytical Method. through
Correspondence.
830.6302.............. Color.............. 3/06/2015 Confirmation 11/04/2015 2 & 4
through
Correspondence.
830.6303.............. Physical State..... 3/06/2015 Confirmation 11/04/2015 2 & 4
through
Correspondence.
830.6304.............. Odor............... 3/06/2015 Confirmation 11/04/2015 2 & 4
through
Correspondence.
830.6313.............. Stability to Normal 3/06/2015 Confirmation 11/04/2015 2 & 4
and Elevated through
Temperatures, Correspondence.
Metals, and Metal.
830.6314.............. Oxidizing or 3/06/2015 Confirmation 11/04/2015 2 & 4
Reducing Action. through
Correspondence.
830.6315.............. Flammability....... 3/06/2015 Confirmation 11/04/2015 2 & 4
through
Correspondence.
830.6316.............. Explodability...... 3/06/2015 Confirmation 11/04/2015 2 & 4
through
Correspondence.
830.6317.............. Storage Stability.. 3/06/2015 Confirmation 07/04/2016 2 & 4
through
Correspondence.
830.6319.............. Miscibility........ 3/06/2015 Confirmation 11/04/2015 2 & 4
through
Correspondence.
830.6320.............. Corrosion 3/06/2015 Confirmation 07/04/2016 2 & 4
Characteristics. through
Correspondence.
830.6321.............. Dielectric 3/06/2015 Confirmation 11/04/2015 2 & 4
Breakdown Voltage. through
Correspondence.
830.7000.............. pH................. 3/06/2015 Confirmation 11/04/2015 2 & 4
through
Correspondence.
830.7050.............. UV/Visible 3/06/2015 Confirmation 11/04/2015 2 & 4
Absorption. through
Correspondence.
830.7100.............. Viscosity.......... 3/06/2015 Confirmation 11/04/2015 2 & 4
through
Correspondence.
830.7200.............. Melting Point/ 3/06/2015 Confirmation 11/04/2015 2 & 4
Melting Range. through
Correspondence.
830.7220.............. Boiling Point/ 3/06/2015 Confirmation 11/04/2015 2 & 4
Boiling Range. through
Correspondence.
830.7300.............. Density/Relative 3/06/2015 Confirmation 11/04/2015 2 & 4
Density. through
Correspondence.
830.7370.............. Dissociation 3/06/2015 Confirmation 11/04/2015 2 & 4
Constants in Water. through
Correspondence.
830.7550.............. Partition 3/06/2015 Confirmation 11/04/2015 2 & 4
Coefficient (n- through
octanol/water), Correspondence.
Shake Flask Method.
830.7560.............. Partition 3/06/2015 Confirmation 11/04/2015 2 & 4
Coefficient (n- through
octanol/water, Correspondence.
Generator Column
Method.
830.7570.............. Partition 3/06/2015 Confirmation 11/04/2015 2 & 4
Coefficient (n- through
octanol/water, Correspondence.
Estimation by
Liquid
Chromatography.
830.7840.............. Water Solubility: 3/06/2015 Confirmation 11/04/2015 2 & 4
Column Elution through
Method, Shake Correspondence.
Flask Method.
830.7860.............. Water Solubility, 3/06/2015 Confirmation 11/04/2015 2 & 4
Generator Column through
Method. Correspondence.
830.7950.............. Vapor Pressure..... 3/06/2015 Confirmation 11/04/2015 2 & 4
through
Correspondence.
870.1100.............. Acute Oral Toxicity 3/06/2015 Confirmation 11/04/2015 2 & 4
through
Correspondence.
870.1200.............. Acute Dermal 3/06/2015 Confirmation 11/04/2015 2 & 4
Toxicity. through
Correspondence.
870.1300.............. Acute Inhalation 3/06/2015 Confirmation 11/04/2015 2 & 4
Toxicity. through
Correspondence.
870.2500.............. Acute Dermal 3/06/2015 Confirmation 11/04/2015 2 & 4
Irritation. through
Correspondence.
870.2600.............. Skin Sensitization. 3/06/2015 Confirmation 11/04/2015 2 & 4
through
Correspondence.
870.2400.............. Acute Eye 3/06/2015 Confirmation 11/04/2015 2 & 4
Irritation. through
Correspondence.
810.2100.............. Sterilants......... 3/06/2015 Confirmation 11/04/2015 2 & 4
through
Correspondence.
810.2200.............. Disinfectants for 3/06/2015 Confirmation 11/04/2015 2 & 4
Use on Hard through
Surfaces. Correspondence.
[[Page 54568]]
810.2300.............. Sanitizers for Use 3/06/2015 Confirmation 11/04/2015 2 & 4
on Hard Surfaces. through
Correspondence.
810.2400.............. Disinfectants and 3/06/2015 Confirmation 11/04/2015 2 & 4
Sanitizers for Use through
on Fabrics and Correspondence.
Textiles.
810.2500.............. Air Sanitizers..... 3/06/2015 Confirmation 11/04/2015 2 & 4
through
Correspondence.
810.2600.............. Disinfectants for 3/06/2015 Confirmation 11/04/2015 2 & 4
Use in Water. through
Correspondence.
----------------------------------------------------------------------------------------------------------------
* Table Notes:
\1\ No 90-day response received.
\2\ Inadequate 90-day response received.
\3\ No data received.
\4\ Inadequate data received.
Table 2-C--List of Requirements for EPA Registration Number 3525-104
----------------------------------------------------------------------------------------------------------------
Reason for
Guideline No. as Date EPA Date registrant Final data due notice of
listed in applicable Requirement name issued DCI received DCI date intent to
DCI suspend *
----------------------------------------------------------------------------------------------------------------
830.1550.............. Product Identity 3/04/2015 Confirmation 11/02/2015 1 & 3
and Composition. through
Correspondence.
830.1600.............. Description of 3/04/2015 Confirmation 11/02/2015 1 & 3
Materials Used to through
Produce the Correspondence.
Product.
830.1620.............. Description of 3/04/2015 Confirmation 11/02/2015 1 & 3
Production Process. through
Correspondence.
830.1650.............. Description of 3/04/2015 Confirmation 11/02/2015 1 & 3
Formulation through
Process. Correspondence.
830.1670.............. Discussion of 3/04/2015 Confirmation 11/02/2015 1 & 3
Formation of through
Impurities. Correspondence.
830.1700.............. Preliminary 3/04/2015 Confirmation 11/02/2015 1 & 3
Analysis. through
Correspondence.
830.1750.............. Certified Limits... 3/04/2015 Confirmation 11/02/2015 1 & 3
through
Correspondence.
830.1800.............. Enforcement 3/04/2015 Confirmation 11/02/2015 1 & 3
Analytical Method. through
Correspondence.
830.6302.............. Color.............. 3/04/2015 Confirmation 11/02/2015 1 & 3
through
Correspondence.
830.6303.............. Physical State..... 3/04/2015 Confirmation 11/02/2015 1 & 3
through
Correspondence.
830.6304.............. Odor............... 3/04/2015 Confirmation 11/02/2015 1 & 3
through
Correspondence.
830.6313.............. Stability to Normal 3/04/2015 Confirmation 11/02/2015 1 & 3
and Elevated through
Temperatures, Correspondence.
Metals, and Metal.
830.6314.............. Oxidizing or 3/04/2015 Confirmation 11/02/2015 1 & 3
Reducing Action. through
Correspondence.
830.6315.............. Flammability....... 3/04/2015 Confirmation 11/02/2015 1 & 3
through
Correspondence.
830.6316.............. Explodability...... 3/04/2015 Confirmation 11/02/2015 1 & 3
through
Correspondence.
830.6317.............. Storage Stability.. 3/04/2015 Confirmation 07/02/2016 1 & 3
through
Correspondence.
830.6319.............. Miscibility........ 3/04/2015 Confirmation 11/02/2015 1 & 3
through
Correspondence.
830.6320.............. Corrosion 3/04/2015 Confirmation 07/02/2016 1 & 3
Characteristics. through
Correspondence.
830.6321.............. Dielectric 3/04/2015 Confirmation 11/02/2015 1 & 3
Breakdown Voltage. through
Correspondence.
830.7000.............. pH................. 3/04/2015 Confirmation 11/02/2015 1 & 3
through
Correspondence.
830.7050.............. UV/Visible 3/04/2015 Confirmation 11/02/2015 1 & 3
Absorption. through
Correspondence.
830.7100.............. Viscosity.......... 3/04/2015 Confirmation 11/02/2015 1 & 3
through
Correspondence.
830.7200.............. Melting Point/ 3/04/2015 Confirmation 11/02/2015 1 & 3
Melting Range. through
Correspondence.
[[Page 54569]]
830.7220.............. Boiling Point/ 3/04/2015 Confirmation 11/02/2015 1 & 3
Boiling Range. through
Correspondence.
830.7300.............. Density/Relative 3/04/2015 Confirmation 11/02/2015 1 & 3
Density. through
Correspondence.
830.7370.............. Dissociation 3/04/2015 Confirmation 11/02/2015 1 & 3
Constants in Water. through
Correspondence.
830.7550.............. Partition 3/04/2015 Confirmation 11/02/2015 1 & 3
Coefficient (n- through
octanol/water), Correspondence.
Shake Flask Method.
830.7560.............. Partition 3/04/2015 Confirmation 11/02/2015 1 & 3
Coefficient (n- through
octanol/water), Correspondence.
Generator Column
Method.
830.7570.............. Partition 3/04/2015 Confirmation 11/02/2015 1 & 3
Coefficient (n- through
octanol/water), Correspondence.
Estimation by
Liquid
Chromatography.
830.7840.............. Water Solubility: 3/04/2015 Confirmation 11/02/2015 1 & 3
Column Elution through
Method, Shake Correspondence.
Flask Method.
830.7860.............. Water Solubility, 3/04/2015 Confirmation 11/02/2015 1 & 3
Generator Column through
Method. Correspondence.
830.7950.............. Vapor Pressure..... 3/04/2015 Confirmation 11/02/2015 1 & 3
through
Correspondence.
870.1100.............. Acute Oral Toxicity 3/04/2015 Confirmation 11/02/2015 1 & 3
through
Correspondence.
870.1200.............. Acute Dermal 3/04/2015 Confirmation 11/02/2015 1 & 3
Toxicity. through
Correspondence.
870.1300.............. Acute Inhalation 3/04/2015 Confirmation 11/02/2015 1 & 3
Toxicity. through
Correspondence.
870.2500.............. Acute Dermal 3/04/2015 Confirmation 11/02/2015 1 & 3
Irritation. through
Correspondence.
870.2600.............. Skin Sensitization. 3/04/2015 Confirmation 11/02/2015 1 & 3
through
Correspondence.
870.2400.............. Acute Eye 3/04/2015 Confirmation 11/02/2015 1 & 3
Irritation. through
Correspondence.
810.2100.............. Sterilants......... 3/04/2015 Confirmation 11/02/2015 1 & 3
through
Correspondence.
810.2200.............. Disinfectants for 3/04/2015 Confirmation 11/02/2015 1 & 3
Use on Hard through
Surfaces. Correspondence.
810.2300.............. Sanitizers for Use 3/04/2015 Confirmation 11/02/2015 1 & 3
on Hard Surfaces. through
Correspondence.
810.2400.............. Disinfectants and 3/04/2015 Confirmation 11/02/2015 1 & 3
Sanitizers for Use through
on Fabrics and Correspondence.
Textiles.
810.2500.............. Air Sanitizers..... 3/04/2015 Confirmation 11/02/2015 1 & 3
through
Correspondence.
810.2600.............. Disinfectants for 3/04/2015 Confirmation 11/02/2015 1 & 3
Use in Water. through
Correspondence.
----------------------------------------------------------------------------------------------------------------
* Table Notes:
\1\ No 90-day response received.
\2\ Inadequate 90-day response received.
\3\ No data received.
\4\ Inadequate data received.
IV. Attachment III Suspension Report--Explanatory Appendix
1. The letter sent to the registrant contains an Attachment III--
Explanatory Appendix. This Explanatory Appendix also follows below and
provides provides a discussion of the basis for the Notice of Intent to
Suspend issued herewith.
A. Aklyl Dimethyl Benzyl Ammonium Chloride (ADBAC)
On March 4, 2015, March 6, 2015, and March 11, 2015, the Agency
issued the Reregistration Eligibility Decision Document (RED) PDCI
Notices numbered: 069184-30960, 069137-30946, 069119-30941, and 069104-
30932 pursuant to FIFRA section 4(g)(2)(B), which required the
registrants of products containing ADBAC used as an active ingredient
to develop and submit certain data. The data/information were
determined to be necessary to satisfy the reregistration requirements
of FIFRA section 4(g). Failure to comply with the requirements of the
RED PDCI is a basis for suspension under FIFRA section 3(c)(2)(B).
The Agency sent PDCIs: 069184-30960, 069137-30946, 069119-30941,
and 069104-30932 on March 4, 6, and 11, 2015 to Qualco, Inc. via the
email address provided to the Agency for Ms. Debbie Schaub, who was the
designated company representative. A Microsoft Outlook server response
email for PDCI-069104-30932 was received on March 11, 2015 by the
Agency to indicate delivery to Ms. Schaub was complete. Subsequently,
the PDCIs were re-sent on March 27, 2015 to an alternative Qualco, Inc.
email address for Ms. Schaub because no response was received after
email delivery to the original email address.
Following a DCI issuance, registrants are required to submit a 90-
day response electing how they will satisfy the DCI
[[Page 54570]]
data requirements. Qualco, Inc. failed to submit a 90-day response
electing how it would satisfy the DCI data requirements.
After three years of no response from Qualco, Inc. on May 21, 2018,
the Agency sent emails to Qualco, Inc. to the attention of Ms. Schaub
and Mr. Peter Ferentinos, who is another designated Qualco, Inc.
representative. In the emails, the Agency discussed the severity of the
PDCI response failures by Qualco, Inc. These emails also forwarded once
again the originally sent PDCIs and email with attachments and
instructions. The Agency received Microsoft Outlook server response
emails for each PDCI (069184-30960, 069137-30946, 069119-30941, and
069104-30932) email that confirmed that delivery to both addresses had
been completed on May 21, 2018.
After hearing nothing from Qualco between May 21 and October 31,
2018 the Agency emailed a Notification of Deficiency letter to Qualco,
Inc. on October 31, 2018 to the attention of Ms. Schaub that warned the
registrant of the pending suspension of the affected Qualco, Inc. ADBAC
products. The email listed the overdue PDCIs and the attached letter
noted the specific deficient data requirements for each listed PDCI,
discussed the lack of an adequate 90-day response for each PDCI,
described how to respond to the deficiency letter, included the list of
then affected (EPA Reg. Nos.: 3525-22, 3525-78, 3525-90, 3525-92, 3525-
94, 3525-97, 3525-99, 3525-100, 3525-103, 3525-104, 3525-106, and 3525-
118), and stated that appropriate and adequate data to satisfy the
overdue data requirements must be received by the Agency within 10
business days measured from the letter receipt by Qualco, Inc. in order
to avoid issuance of Notices of Intent to Suspend. The Agency received
a Microsoft Outlook server email on October 31, 2018 indicating that
the email and the attached information had been received by Qualco,
Inc. on October 31, 2018.
The same October 31, 2018 Notification of Deficiency letter was
mailed via the US Postal Service on November 8, 2018 along with another
Notification of Deficiency letter for another chemical case (Busan 77).
The Agency subsequently sent Qualco, Inc. an email to the attention
of Ms. Schaub on November 20, 2018 stating that a voicemail had been
left for Ms. Schaub. The November 20, 2018 email and voicemail both
requested a meeting to discuss the ADBAC and Busan 77 DCIs. The Agency
proposed meeting dates and times in the November 20, 2018 email. The
November 20, 2018 email included the October 31, 2018 email discussed
above as part of its chain of prior correspondence.
Ms. Schaub responded by email to the Agency's November 20, 2018
email on November 26, 2018. The Agency's October 31, 2018 email with
the initial Notification of Deficiency warning letter was included in
the chain of emails that were part of her email response. Qualco, Inc.,
through Ms. Schaub, suggested scheduling a November 28, 2018 meeting in
her November 26, 2018 email.
An Agency email response was sent to Ms. Schaub on November 26,
2018 confirming the scheduling of a November 28, 2018 teleconference
meeting at 1 p.m. On November 28, 2018 the Agency and Ms. Schaub met
via teleconference to discuss the overdue data requirements of PDCIs:
069104-30932, 069119-30941, 069137-30946, 069184-30960, and the
affected Qualco products (EPA Reg. Nos.: 3525-22, 3525-78, 3525-90,
3525-92, 3525-94, 3525-97, 3525-99, 3525-100, 3525-103, 3525-104, 3525-
106, and 3525-118).
Ms. Schaub subsequently sent the Agency an email on December 3,
2018 to inform the Chemical Review Manager that a DCI response was
being put together for ADBAC, that errors were received after an
attempt to upload files to the EPA CDX, and to ask what other specific
forms were required for the PDCI response.
The Agency responded by email on December 3, 2018 and attached
another copy of the PDCI-069104-30932 for Ms. Schaub's reference. This
PDCI was attached as a representative DCI to illustrate what needed to
be done by Qualco to adequately respond to all issued PDCIs. The Agency
once again stated that instructions and required forms for Qualco's
response are explained in the PDCI. The CDX helpdesk contact
information was provided for Ms. Schaub's reference. However, the
Agency requested that Qualco's responses be sent directly by email to
the Chemical Review Manager to avoid CDX errors or the product
suspension process would continue. In the Agency December 3, 2018
email, a list of all the affected Qualco products pending suspension
(EPA Reg. Nos.: 3525-22, 3525-78, 3525-94, 3525-97, 3525-99, 3525-100,
3525-103, 3525-104, 3525-106, and 3525-118) was attached. The December
3, 2018 email also noted that two products (3525-90 and 3525-92)
originally listed in the October 31, 2018 letter had been voluntarily
cancelled.
Ms. Schaub responded to the Agency's December 3, 2018 email chain
by providing attachments, including data matrices, Confidential
Statement of Formulas (CSF), and other forms, for 5 of the 10 products
pending suspension (EPA Reg. Nos.: 3525-22, 3525-78, 3525-94, 3525-106,
and 3525-118). Ms. Schaub stated in the December 3, 2018 email that
additional forms and responses for the other 5 products (EPA Reg. Nos.:
3525-103, 3525-104, 3525-97, 3525-99, and 3525-100) would be submitted
through a second CDX attempt.
On December 4, 2018 the Agency stated through email that the
submitted ADBAC PDCI responses would be reviewed. The Agency requested
that Ms. Schaub submit the remaining responses and suggested that, if
some products are dormant, then Qualco may opt to voluntarily cancel
those products.
On December 5, 2018, an email from the CDX system to the EPA
Antimicrobials Divison Reevaluation mailbox was received. The December
5, 2018 CDX email indicated that a DCI response for only PDCI-069137-
30946 had been submitted and included data matrices, citation forms,
and correspondence for only EPA Registration Nos.: 3525-100, 3525-103,
3525-97, and 3525-99. No submissions were provided for EPA registration
number 3525-104 by email or CDX.
The Agency sent an email on December 5, 2018 to Ms. Schaub
informing Qualco that the emailed submissions were reviewed but
numerous errors were found. The Agency's December 5, 2018 email
requested that corrected responses be sent as soon as possible. The
following list summarizes the errors.
The ``Requirements Status & Registrant's Response'' forms
listed response code 9; however, this code does not exist for PDCI
responses and is not an adequate or appropriate response. This error
pertains to the following products: EPA Reg. Nos.: 3525-22, 3525-78,
3525-94, 3525-106, and 3525-118.
The ``Requirements Status & Registrant's Response'' forms
were not adequately completed. This error pertains to the following
products: EPA Reg. Nos.: 3525-97, 3525-99, 3525-100, and 3525-103.
The data matrices submitted for EPA Reg. Nos.: 3525-22,
3525-78, 3525-94, 3525-97, 3525-99, 3525-100, 3525-103, and 3525-106
are missing anything to address the 810 data requirements.
The Formulator's Exemption form for EPA Reg. No.: 3525-118
states that the product's source is EPA Reg. No.
[[Page 54571]]
3525-118, which is stating that the product is formulated with itself
and this is neither an adequate nor appropriate response.
Qualco, Inc. chose the option to cite another registrant's
study for product specific data for the following products: EPA Reg.
Nos.: 3525-22, 3525-78, 3525-97, 3525-99, 3525-100, 3525-103, and 3525-
106. However, Qualco did not provide the appropriate MRID Accession
number(s) or an adequately completed ``Certification with Respect to
Data Compensation Requirements'' form. The submitted ``Certification
with Respect to Citation of Data'' forms cannot state ``cite all'' for
PDCIs unless the ``Certification with Respect to Data Compensation''
form is submitted with the appropriate MRID Accession number(s).
Qualco, Inc. has not responded to the Agency's December 5, 2018
email and has not to-date satisfied the overdue PDCI requirements for
its affected products. Therefore, this Notice of Intent to Suspend is
being issued for EPA Registration Nos.: 3525-22, 3525-78, 3525-94,
3525-97, 3525-99, 3525-100, 3525-103, 3525-104, 3525-106, and 3525-118.
V. How to avoid suspension under this notice?
1. You may avoid suspension under this notice if you or another
person adversely affected by this notice properly request a hearing
within 30 days of your receipt of the Notice of Intent to Suspend by
mail or, if you did not receive the notice that was sent to you via
USPS first class mail return receipt requested, then within 30 days
from the date of publication of this Federal Register notice (see
DATES). If you request a hearing, it will be conducted in accordance
with the requirements of FIFRA section 6(d) (7 U.S.C. 136d) and the
Agency's procedural regulations in 40 CFR part 164. Section 3(c)(2)(B)
of FIFRA (7 U.S.C. 136a), however, provides that the only allowable
issues which may be addressed at the hearing are whether you have
failed to take the actions which are the bases of this notice and
whether the Agency's decision regarding the disposition of existing
stocks is consistent with FIFRA. Therefore, no substantive allegation
or legal argument concerning other issues, including but not limited to
the Agency's original decision to require the submission of data or
other information, the need for or utility of any of the required data
or other information or deadlines imposed, any allegations of errors or
unfairness in any proceedings before an arbitrator, and the risks and
benefits associated with continued registration of the affected
product, may be considered in the proceeding. The Administrative Law
Judge shall by order dismiss any objections which have no bearing on
the allowable issues which may be considered in the proceeding. Section
3(c)(2)(B)(iv) of FIFRA provides that any hearing must be held and a
determination issued within 75 days after receipt of a hearing request.
This 75-day period may not be extended unless all parties in the
proceeding stipulate to such an extension. If a hearing is properly
requested, the Agency will issue a final order at the conclusion of the
hearing governing the suspension of your products. A request for a
hearing pursuant to this notice must:
Include specific objections which pertain to the allowable
issues which may be heard at the hearing.
Identify the registrations for which a hearing is
requested.
Set forth all necessary supporting facts pertaining to any
of the objections which you have identified in your request for a
hearing.
If a hearing is requested by any person other than the registrant,
that person must also state specifically why he/she asserts that he/she
would be adversely affected by the suspension action described in this
notice. Three copies of the request must be submitted to: Hearing
Clerk, 1900, Environmental Protection Agency, 1200 Pennsylvania Ave.
NW, Washington, DC 20460-0001.
An additional copy should be sent to the person who signed this
notice. The request must be received by the Hearing Clerk by the
applicable 30th day deadline as measured from your receipt of the
Notice of Intent to Suspend by mail or publication of this notice, as
set forth in DATES and in Unit IV.1., in order to be legally effective.
The 30-day time limit is established by FIFRA and cannot be extended
for any reason. Failure to meet the 30-day time limit will result in
automatic suspension of your registrations by operation of law and,
under such circumstances, the suspension of the registration for your
affected products will be final and effective at the close of business
on the applicable 30th day deadline as measured from your receipt of
the Notice of Intent to Suspend by mail or publication of this notice,
as set forth in DATES and in Unit IV.1., and will not be subject to
further administrative review. The Agency's rules of practice at 40 CFR
164.7 forbid anyone who may take part in deciding this case, at any
stage of the proceeding, from discussing the merits of the proceeding
ex parte with any party or with any person who has been connected with
the preparation or presentation of the proceeding as an advocate or in
any investigative or expert capacity, or with any of their
representatives. Accordingly, the following EPA offices, and the staffs
thereof, are designated as judicial staff to perform the judicial
function of EPA in any administrative hearings on this Notice of Intent
to Suspend: The Office of the Administrative Law Judges, the Office of
the Environmental Appeals Board, the EPA Administrator, the EPA Deputy
Administrator, and the members of the staff in the immediate offices of
the EPA Administrator and EPA Deputy Administrator. None of the persons
designated as the judicial staff shall have any ex parte communication
with trial staff or any other interested person not employed by EPA on
the merits of any of the issues involved in this proceeding, without
fully complying with the applicable regulations.
2. You may also avoid suspension if, within the applicable 30-day
deadline period as measured from your receipt of the Notice of Intent
to Suspend by mail or publication of this notice, as set forth in DATES
and in Unit IV.1., the Agency determines that you have taken
appropriate steps to comply with the FIFRA section 3(c)(2)(B) DCI
notice. In order to avoid suspension under this option, you must
satisfactorily comply with Table 2.--List of Requirements in Unit II.,
for each product by submitting all required supporting data/information
described in Table 2 of Unit. II. and in the Explanatory Appendix (in
the docket for this Federal Register notice) to the following address
(preferably by certified mail):
Office of Pesticide Programs, Antimicrobials Division (7510P),
Environmental Protection Agency, 1200 Pennsylvania Ave. NW, Washington,
DC 20460-0001.
For you to avoid automatic suspension under this notice, the Agency
must also determine within the applicable 30-day deadline period that
you have satisfied the requirements that are the bases of this notice
and so notify you in writing. You should submit the necessary data/
information as quickly as possible for there to be any chance the
Agency will be able to make the necessary determination in time to
avoid suspension of your products. The suspension of the registrations
of your company's products pursuant to this notice will be rescinded
when the Agency determines you have complied fully with the
requirements which were the bases of this notice. Such
[[Page 54572]]
compliance may only be achieved by submission of the data/information
described in Table 2 of Unit II.
VI. Status of Products That Become Suspended
Your product will remain suspended, however, until the Agency
determines you are in compliance with the requirements which are the
bases of this notice and so informs you in writing.
After the suspension becomes final and effective, the registrants
subject to this notice, including all supplemental registrants of
products listed in Table 1 of Unit II., may not legally distribute,
sell, use, offer for sale, hold for sale, ship, deliver for shipment,
or receive and (having so received) deliver or offer to deliver, to any
person, the products listed in Table 1 of Unit II. Persons other than
the registrants subject to this notice, as defined in the preceding
sentence, may continue to distribute, sell, use, offer for sale, hold
for sale, ship, deliver for shipment, or receive and (having so
received) deliver or offer to deliver, to any person, the products
listed in Table 1 of Unit II. Nothing in this notice authorizes any
person to distribute, sell, use, offer for sale, hold for sale, ship,
deliver for shipment, or receive and (having so received) deliver or
offer to deliver, to any person, the products listed in Table 1 of Unit
II. in any manner which would have been unlawful prior to the
suspension.
If the registrations for your products, listed in Table 1 of Unit
II., are currently suspended as a result of failure to comply with
another FIFRA section 3(c)(2)(B) DCI notice or FIFRA Section 4 Data
Requirements notice, this notice, when it becomes a final and effective
order of suspension, will be in addition to any existing suspension,
i.e., all requirements which are the bases of the suspension must be
satisfied before the registration will be reinstated.
It is the responsibility of the basic registrant to notify all
supplementary registered distributors of a basic registered product
that this suspension action also applies to their supplementary
registered products. The basic registrant may be held liable for
violations committed by their distributors.
Any questions about the requirements and procedures set forth in
this notice or in the subject FIFRA section 3(c)(2)(B) DCI notice,
should be addressed to the person listed under FOR FURTHER INFORMATION
CONTACT.
(Authority: 7 U.S.C. 136 et seq.)
Dated: August 19, 2020.
Anita Pease,
Director, Antimicrobials Division, Office of Pesticide Programs.
[FR Doc. 2020-19370 Filed 9-1-20; 8:45 am]
BILLING CODE 6560-50-P
