documentation in Appendix 1 (parameter group genesisVisitor, parameter <initSize>) describes
these computations.  However, although the simulations used these values to specify an initial
population distribution, the model altered these values to reflect the simulated impact of birth,
death, and slaughter.  As a result of these influences, the initial population of approximately 140
3
The possibility of spontaneous development of BSE is the one exception to this generalization because its rate is
proportional to the size of the population.  By overstating the size of the population, we have therefore overstated the
potential impact of spontaneous disease, should it exist (See <IP_ADDRESS>.)

Section 3
-
49 -
million decreases to and stabilizes at approximately 130 million during execution of the
simulation.  As noted above, this change has a very limited impact on the simulation results.
Slaughter Rate
Animals are removed from the herd for slaughter at different rates depending on age, type
and gender.  The base case assumptions for the slaughter rates are based on statistics recorded by
USDA and are detailed in Table <rateSlaughter> of the rateSlaughter file (see Appendix 1).
Death Rate for Reasons Other Than Slaughter
The so-called “natural death rate” may be potentially important because some fraction of
these animals, also referred to as animals that die on the farm, are sent to rendering.  Animals that
die on the farm due to BSE infection have the maximum level of infectivity and therefore
introduce the possibility that a substantial amount of BSE contamination could enter the
rendering system.  The base case assumes that animals with BSE will live only 2 to 6 months
after reaching the clinical stage of the disease.  The natural death rates assumed by the base case
appear in Table <probDeath> in file deathVisitor (see Appendix 1).
Birth rate assumptions
The base case assumes that female cattle can calve between the ages of 24 and 180
months.  During that time, they produce a calf once every 12 months on average.  Documentation
accompanying the birthVisitor file (see Appendix 1) explains the basis for these assumptions.
<IP_ADDRESS>  Cattle Consumption of Bypass protein and Blood Meal
MBM is one supplement for livestock feed, although in the U.S., other sources are also
used, especially vegetable protein derived primarily from soybeans.  The primary hypothesis for
the spread of BSE in the UK is that infectious materials was recycled through the rendering and
feed production processes resulting in the subsequent exposure of cattle.  The amount of bypass
protein-supplemented feed consumed by an animal, and hence its potential exposure to MBM,
depends on the animal’s age, type, and gender.  Dairy cows receive the greatest amounts of
supplemental bypass protein.  Because the base case assumes that there may be breaches of the

Section 3
-
50 -
FDA feed ban (Section 3.1.3), some exposure can occur as the result of exposure to feed if BSE is
present in the U.S.  The <consumption> table in files proteinInfector and bloodInfector
respectively detail our assumptions for cattle consumption of bypass protein and blood meal.
<IP_ADDRESS> BSE Dose-Response
The dose-response function for BSE quantifies the probability that an exposed animal
will become infected with BSE as the result of ingesting contaminated materials.  The exposure is
quantified in terms of the number of susceptibility-adjusted ID s ingested.  The susceptibility-
50
adjusted ID
50
exposure equals the product of an age-specific susceptibility factor and the number
of unadjusted ID s ingested.  The base case assumes that the dose response is linear up to an
50
exposure level of 2.0 adjusted ID s, with an infection probability of zero at an exposure level of
50
zero, and an infection probability of 1.0 at an exposure level of 2.0 adjusted ID s.  For example,
50
an animal that ingests 1.0 susceptibility-adjusted ID s has a 50% chance of becoming infected.
50
Note that an animal that ingests more than 2.0 adjusted ID s has a 100% chance of becoming
50
infected.  Figure 3-3 illustrates the straight-line dose-response relationship assumed as part of the
base case, along with a hypothetical alternative sigmoidal dose-response relationship.
Our relationship between susceptibility and age (see Figure 3-4) is based on the
assumption that susceptibility peaks at age four months and that it declines exponentially
thereafter at a rate of 85% per year, leveling off at approximately 10% of its peak value  (Koeijer
et al., In press).  Table <susceptibility> in file proteinInfector (see Appendix 1) details this
relationship.  Section 2 provides further background on susceptibility.
<IP_ADDRESS> Maternal Transmission
Although there is no direct evidence of BSE transmission from cow to calf, it is assumed
to have occurred when a calf born to a cow incubating BSE contracts the disease in the absence of
any other known sources of BSE exposure.  Section 2.2.1 reviews evidence of maternal
transmission for other TSEs, with the best evidence from scrapie (Kimberlin, 1990, Foster et al.,
1992, Elsen et al., 1999), and for BSE (Wilesmith et al., 1997, Ferguson et al., 1997b, Donnelly et
al., 1997a, Donnelly et al., 1997b, Donnelly, 1998).  The base case assumes calves born to
infected cows during the last one-sixth of the incubation period will become infected with 10%
probability.  Text accompanying table <maternalContagiousPoint> in file sickBovine and table

Section 3
-
51 -
<probTrans> in file birthVisitor (see Appendix 1) further documents the basis for these two
parameter values.
<IP_ADDRESS>  The BSE Incubation Period, and Time Until Death Caused by BSE
The base case assumes that the duration between infection and manifestation of clinical
signs follows a distribution described inferred by Ferguson et al. (1997) (Ferguson et al., 1997a)
from data collected in the UK.  The density is right-skewed with a median of approximately four
years.  The 5 percentile is approximately 2.5 years, the median is approximately four years, and
th
the 95 percentile is approximately seven years.  Table <clinicalDate> in file sickBovine (see
th
Appendix 1) further details this distribution.
The base case assumes that the time between the manifestation of clinical signs and death
is uniformly distributed between 2 and 6 months (Dagmar Heim, Personal Communication).
Table <clinicalDuration> in file sickBovine (see Appendix 1) documents this assumption.
3.1.2
The Slaughter Process
If an animal with BSE is slaughtered, some practices can contaminate tissues destined for
potential human consumption with BSE infectivity.  In addition, many tissues not used for human
consumption go to rendering and may become available to infect other bovines (Section 3.1.3).
This section describes the base case assumptions for the slaughter process (Figure 3-5).  It also
describes ways in which infectivity can be diverted from uses that may result in either human or
bovine exposure.
<IP_ADDRESS>  Level of Infectivity and Distribution of Infectivity Throughout the Carcass
The amount of infectivity that becomes available for human consumption or ends up
being recycled into cattle feed depends in part on the total amount of infectivity in a slaughtered
animal and how that infectivity is distributed through its carcass.  Our model assumes these
factors depend on the amount of time that has passed since the slaughtered animal became
infected.  Tables <organDistribution> and <totalInfectivity> in file materializer (see Appendix 1)
details our base case assumptions.

Section 3
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52 -
Our description of the distribution of infectivity among the tissues of an infected animal
is based on the pathogenesis experiment (Wells et al., 1998, Wells et al., 1999), as interpreted by
SEAC (February, 1998).  This experiment measured the infectivity in each of 44 tissues and
fluids following experimental infection of cows with BSE.  The experiment found infectivity in
the small intestine from months 6 to 18 months post infection, with no detectable infectivity in
any other tissues.  At the end stage of disease, (
≥
32 months post infection), infectivity was found
in the brain, spinal cord, dorsal root ganglia (DRG), trigeminal ganglia (TGG), and again in the
small intestine.  We assume that findings of infectivity in bone marrow at one time point were
spurious, although we do investigate the potential for the disease to directly infect blood (so-
called “inherent infectivity”) (Section 3.2.6).  Table 3-1 details our specific assumptions.
Note that these assumptions are based on an assumed incubation period of 36 months (as
observed in the pathogenesis study).  For animals with incubation periods of durations other than
36 months, the time periods post inoculation are scaled accordingly. For example, for an animal
with an incubation period of 72 months, there is no infectivity in the brain prior to month 64 (i.e.,
32
×
72 / 36).

Section 3
-
53 -
Table 3-1
Relative Infectivity of Specific Tissues Specified From an Infected Bovine
(Based on (SSC, 1999a))
a
Tissue
Fraction of Total Infectivity
Brain
No infectivity in cattle < 32 months post-inoculation (PI)
32 months PI and over: 64.1%
Trigeminal Ganglia
No infectivity in cattle < 32 months post-inoculation.
32 months PI and over: 2.6%
Other Head (eyes, etc.)
No infectivity in cattle < 32 months post-inoculation.
32 months PI and over: 0.04%
Distal Ileum
6-18 months post inoculation: 100%
18-31: No Infectivity
32 months PI and over 3.3%
Spinal Cord
No infectivity in cattle < 32 months post-inoculation.
32 months PI and over: 25.6% infectivity
Dorsal Root Ganglia
No infectivity in cattle < 32 months post-inoculation.
32 months PI and over: 3.8 % infectivity
Notes:
a.
The post-inoculation time values in this table reflect the assumption that the incubation period is 36
months.  See text for explanation.
The base case assumes that the total quantity of infectivity in an animal with BSE reaches
its maximum level when the animal develops clinically detectable signs (i.e., becomes “clinical”)
(see Section <IP_ADDRESS> for a discussion of the incubation period duration).  Prior to that time, the
total level of infectivity follows the pattern illustrated in Figure 3-6.  In this example, the animal
develops clinical signs 36 months after infection.  During the first five months of infection, total
infectivity in the animal is around 0.1% of its maximum value, followed by an increase to around
2.5% of its maximum value between months 6 and 18 post infection.  Up until this point, all
infectivity is assumed to be in the gut.  Starting in month 19, infectivity is assumed to be
distributed among several tissues, with the bulk in the brain and the spinal cord, and the
remainder divided among the gut, DRG, eyes, and TGG.  At this time, total infectivity drops to
zero but and then grows exponentially until it reaches its maximum level in month 36.  For
incubation periods other than 36 months, the model scales the horizontal (time) axis in Figure 3-6
proportionally.  The total amount of infectivity in an animal with clinical BSE is assumed to

Section 3
-
54 -
10,000 cattle oral ID s (SSC, 1999a, SEAC, 2000, Gale and Stanfield, 2001).  Note that this
50
value has not been adjusted to reflect age-specific susceptibility (see Section <IP_ADDRESS>).
<IP_ADDRESS> Antemortem Inspection
Once the animal is at the slaughter facility, it is inspected for signs of disease.  FSIS
regulations require that for certain diseases the whole animal is condemned at antemortem (AM)
inspection (USDA-FSIS, 1997).  Condemned animals can be rendered or incinerated.
Animals not showing clinical signs at AM inspection are not likely to be condemned for
BSE but could be condemned if they show signs of other diseases.  The condemnation rates for
animals not showing clinical BSE signs depend on age and gender.  The rates used in the base
case are based on data collected by FSIS for the year 1998 (see Table 3-2).  In particular, the base
case assumes that the AM condemnation rate is approximately 1% for animals less than one year
of age, 0.01% for animals between the ages of one year and 31 months, and 0.2% for animals
older than 31 months of age.
Table 3-2
Cattle Slaughtered and Condemned (1998)
a
Cattle
age group
Total
Animals
slaughtered
Total
Animals
Condemned
Probability
not pass
AM
Animals
Condemned
Postmortem
Probability
that will not
pass
Postmortem
< 12 months
1,483,430
14859
0.0098
13,799
0.0092
12 to 24 months
32,690,003
2,349
0.0001
22,697
0.0007
≥
24 months
7,815,074 21,906  0.0028  11,0172  0.0139
Notes:
a.
From USDA: Animal Disposition Reporting System
Animals that are condemned following AM inspection are usually rendered, although a
small proportion are incinerated.  The base case assumes that 98% of condemned animals are
rendered and that the rest are incinerated.  The likelihood that an animal condemned at AM
inspection is rendered or incinerated is assumed to be independent of its BSE status.  The means
of disposal is important because animals that are incinerated cannot contaminate human food or
animal feed.

Section 3
-
55 -
Animals that do manifest the clinical signs of BSE can be identified by AM inspectors.  It
is also possible that farmers might hold back from slaughter animals with BSE signs to prevent
the case from being discovered.  It is difficult to estimate how effectively U.S. inspectors would
be at detecting an animal with BSE signs because the disease has not been detected in this
country.  The USDA has conducted training for inspectors to make them aware of these signs.
The effectiveness of inspectors at detecting other CNS diseases could in concept be used to
estimate how effective they would be at detecting animals with clinical signs of BSE.  In practice,
however, the prevalence rate for these other diseases are often unknown.  Our base case assumes
that clinical BSE cases would be detected at AM inspection 90% of the time.  Because this value
is highly uncertain, our uncertainty analysis evaluates the impact of using a wide range of values
on the results of our simulation (see Section 3.2.2).
<IP_ADDRESS> Stunning
Stunning humanely renders animals unconscious for slaughter.  It is usually performed by
mechanical devices, most commonly captive bolts that may or may not penetrate the skull.  One
type of penetrating captive bolt is referred to as an “air-injected pneumatic stunner” because it
injects a jet of air into the brain at the end of the cylinder stroke.  Stunners that use air injection
can deposit CNS tissue emboli in blood, heart, lung, and liver.  Malfunctions in these devices
both increase the probability that emboli will be created and the amount of emboli that will be
deposited.  However, based on our conversations with USDA personnel (in headquarters and in
the field), individuals in the beef packing industry, and others, the base case assumes that air-
injected stunning is not currently used in the U.S. cattle industry. Other scenarios evaluating past
practices do assume the use of air-injected pneumatic stunning (see Section 3.2.2).
There is also some concern that other stunning methods may produce CNS micro-emboli
that could contaminate blood (SSC, 2000b).  The base case assumes that stunners not using air
injection can create very small emboli that are found only in blood.  The amount of emboli in the
blood is not affected by whether the stunner malfunctions.
The discussion in Appendix 1 for the <emboli> parameter in the stunner parameter group
provides additional background on the development of these assumptions.

Section 3
-
56 -
<IP_ADDRESS> Exsanguination
Following stunning, animals are bled.  Bovine blood can be processed for human
consumption, processed to make blood meal that can be used in ruminant feed, rendered, or
disposed of.  The base case assumes that 15% of blood is made into blood meal that has the
potential to be used in cattle feed.  The base case also assumes that blood collected for human
consumption is not contaminated with emboli.
Blood collected to produce meal for animal consumption may become contaminated with
CNS tissue if some of that tissue drips from the hole created by the stunner.  The base case
assumes that air-injected pneumatic stunners generate this type of contamination with 30%
probability, and that when this contamination does occur, 4% of the infectivity in the brain ends
up in the blood being collected.  The base case assumes that stunners that do not use air injection
never cause this type of contamination.
<IP_ADDRESS>  Disposition of Brain
Following exsanguination, the head is removed from the carcass.  USDA has mandated
inspection of some parts of the head that are collected for human consumption (e.g, tongue).
Because brain is the tissue with the greatest amount of infectivity in an animal with advanced
BSE, the disposition of the head is important.  There are no available data on the fraction of
brains collected for sale as human food.  The base case assumes that 1% of the brains are
removed for potential human consumption in the U.S. and that the rest are rendered.
<IP_ADDRESS>  Splitting and Aerosolization
After removal of the head, the carcass is split longitudinally with a saw to facilitate
handling and further processing.  When the carcass is split some spinal cord is aerosolized and
can contaminate edible meat.  Based on data from experiments that measured the amount of
spinal cord associated protein deposited on the carcass during splitting (Harbour, 2001), the base
case assumes that approximately 0.001% (2.5 mg) of the spinal cord contaminates edible meat.
The base case further assumes that additional carcass treatments, like washing and steaming, do
not reduce the amount of contamination.  Documentation accompanying table <fracAerosol> in
file splitter (see Appendix 1) documents this assumption.

Section 3
-
57 -
<IP_ADDRESS>  Disposition of the Spinal Cord and Dorsal Root Ganglia
The vertebrae of the animal are arranged in a column that houses and protects the spinal
canal.  Because spinal cord and the dorsal root ganglia (DRG), which are nerve ends emerging
from the spinal cord, can contain BSE infectivity, their disposition influences the extent to which
meat recovered for human consumption may become contaminated.  The magnitude of this
contamination and which selections of meat become contaminated depend on whether a mis-split
occurs, whether the slaughter plant uses advanced meat recovery (AMR), and whether it removes
the spinal cord from the carcass.  The extent to which AMR product becomes contaminated is
particularly sensitive to mis-splits because they can leave behind pieces of spinal cord
encapsulated in the vertebral column that are processed by AMR. This section first discusses the
frequency of mis-splits, the proportion of carcasses processed using AMR, and the proportion
from which the spinal cord is removed.  Finally, it discusses how mis-splitting, AMR, and spinal
cord removal influences contamination.
Mis-split frequency
Mis-splitting refers to the incomplete cutting of the spinal column with a saw. A mis-
split occurs when the cut veers off the vertical and terminates at a point short of the cervical
vertebrae (carcasses are split caudal to cranial).  The likelihood that mis-splitting will occur
depends on the size and age of the animal (e.g., calves are more likely to be mis-split than bulls or
cows) and the proficiency of the saw operator.  The rate and extent of mis-splitting influences the
potential for spinal cord from an infected animal to contaminate human food, primarily in the
Advanced Meat Recovery process (Section <IP_ADDRESS>).  The base case assumes that among animals
below the age of 24 months, mis-splits occur 5% of the time, whereas for older animals, mis-
splits occur 8% of the time.  Table <probMS_AMR_SCRemove> in file splitter (see Appendix 1)
details estimates of the rate and extent of mis-splits.
The proportion of cattle processed using AMR
Once the carcass is split, the disposition of the spinal cord depends on whether or not the
slaughter facility processes the vertebrae using advanced meat recovery (AMR).  AMR machines
process bones to recover meat remaining after the hand deboning process is completed.  USDA
rules allow the AMR product to be labeled as “meat”.  Approximately 70% of fed cattle and 60%

Section 3
-
58 -
of cows are processed in facilities that use AMR (Sparks Companies, 1999).  The base case
assumes that AMR is used to process no animals below the age of 12 months, 65% of animals
between the ages of 12 and 23 months, and 60% of animals 24 months of age or older.
Spinal cord removal – Plants that use AMR
An FSIS directive requires that the spinal cord be removed from the vertebral column
before the backbones enter the AMR process.  The base case assumes that spinal cords are
removed with 98% probability in plants using AMR. Spinal cords removed in this manner are
rendered.  In the event that spinal cord is not removed prior to AMR, it can contaminate the AMR
product, although the probability of this occurring is small.  In addition, if the carcass is mis-split,
the spinal cord that remains encapsulated in the spinal canal (usually a small portion of the spinal
cord) contaminates AMR product unless it is removed by facility personnel.  Whether an AMR
processing system is used depends on the size and age of the animal (e.g., calves are not likely to
go through AMR).  The amount of spinal cord left behind that can contaminate edible meat also
depends on the age and type of the animal (e.g., for steers and heifers, the lumbar area does not
go through AMR because T-bone steaks are more profitable).
Spinal cord Removal – Plants that do not use AMR
If a facility does not use AMR, FSIS does not require removal of the spinal cord from the
carcass.  However, some slaughterhouses choose to remove it and send it to rendering.  The base
case assumes that spinal cords are removed with 50% probability in plants that do not use AMR.
If the spinal cord is not removed, it remains in certain cuts of beef and is hence available for
potential human consumption (e.g., T-bone steak).  In addition, spinal cord left in the carcass can
contaminate the boning table.  Finally, a small fraction of the spinal cords removed from steers
and heifers are destined for human consumption.
Fraction of spinal cord and DRG that contaminate meat recovered for human
consumption
The DRG are firmly attached to the bones of the spinal column and are not removed even
if the spinal cord is removed.  The disposition of the DRG depends on the cuts of beef recovered
for human consumption (which depend on the age of the animal) and on the use of AMR
processing systems.  For example, some cuts of meat from young animals, such as steers and

Section 3
-
59 -
heifers, might be sold with the vertebrae attached (e.g., T-bone steaks), and in those particular
circumstances DRG can reach the consumer.  However, it is important to note that even if DRG
reaches the consumer, it is unlikely to be consumed unless the bone is aggressively cleaned.  In
other regions of the vertebral column, DRG will remain attached to the bone because they are
unlikely to be removed by standard deboning operations.  The vertebrae and DRG from young
animals are likely to be rendered.  For older animals (e.g., bulls and cows) that are deboned by
hand, DRG will not reach the consumer and will instead be rendered.
If the spinal column is processed using AMR, the DRG are likely to contaminate the
AMR product.  For young animals, only a fraction of the vertebral column and DRG will be
processed using AMR because parts of the backbone are contained in high value bone-in cuts of
meat.  For older animals, such as bulls or cows, all vertebrae are likely to be processed using
AMR. If the facility does not process the spinal column using AMR, other technology, such as
vibration or hand held knives (e.g., Whizzard knives), are used to recover the remaining meat
attached to the bones.  Because of the location of the DRG and the presentation of the backbones
on the boning table, these knives are unlikely to incorporate DRG or spinal cord into meat or
ground beef.
Tables <fracDRGInMuscle>, <fracDRGInAMRMeat>, and <fracDRGInBone> in file
splitter (see Appendix 1) detail the fraction of the infectivity in DRG that ends up contaminating
muscle, AMR product, or remains connected to the bone, respectively. These values depend on
whether a mis-split occurs, the use of AMR, and on whether the spinal cord is removed.  Tables
<fracSCInMuscle>, <fracSCInAMRMeat>, and <fracSCInBone> in file splitter (see Appendix 1)
provide the corresponding assumptions for spinal cord contamination.
<IP_ADDRESS> Postmortem Inspection
Organs and tissues from cattle passing AM inspection are inspected postmortem (PM) to
ensure fitness for human consumption.  FSIS regulations require that the whole animal be
condemned when certain diseases are suspected, while for other diseases and conditions, only
some tissues are excluded from use in human food.  There are no visible characteristics of BSE
cattle that can be detected at PM inspection. Nevertheless, the base case assumes that some
infected animals or tissues from animals with BSE are condemned at PM inspection for reasons
other than the presence of BSE.  These condemnation rates have been measured and reported by

Section 3
-
60 -
FSIS (Table 3-2).  The FSIS data specify rates by age and gender.  The base case rates appear in
Table <probPassPM> in file PMInspector (see Appendix 1).
<IP_ADDRESS> Processing
After the carcass is split, meat for human consumption is recovered.  Some potentially
infectious tissues may be purposely recovered for potential human consumption.  The existence


[Federal Register Volume 88, Number 130 (Monday, July 10, 2023)]
[Rules and Regulations]
[Pages 43442-43446]
[FR Doc No: 2023-14404]

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

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2021-0646; FRL-11057-01-OCSPP]

Benzpyrimoxan; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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

SUMMARY: This regulation establishes tolerances for residues of
benzpyrimoxan in or on rice, husked; rice, polished rice; and rice,
bran. Nichino America, Inc. requested these tolerances under the
Federal Food, Drug, and Cosmetic Act (FFDCA).

DATES: This regulation is effective July 10, 2023. Objections and
requests for hearings must be received on or before September 8, 2023
and must be filed in accordance with the instructions provided in 40
CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).

ADDRESSES: The docket for this action, identified by docket
identification (ID) number EPA-HQ-OPP-2021-0646, is available at
https://www.regulations.gov or at the Office of Pesticide Programs
Regulatory Public Docket (OPP Docket) in the Environmental Protection
Agency Docket Center (EPA/DC), West William Jefferson Clinton Bldg.,
Rm. 3334, 1301 Constitution Ave. NW, Washington, DC 20460-0001. The
Public Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through
Friday, excluding legal holidays. The telephone number for the Public
Reading Room and the OPP docket is<PHONE_NUMBER>. For the latest
status information on EPA/DC services, docket access, visit https://www.epa.gov/dockets.

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

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this action apply to me?

    You may be potentially affected by this action if you are an
agricultural producer, food manufacturer, or pesticide manufacturer.
The following list of North American Industrial Classification System
(NAICS) codes is not intended to be exhaustive, but rather provides a
guide to help readers determine whether this document applies to them.
Potentially affected entities may include:
     Crop production (NAICS code 111).
     Animal production (NAICS code 112).
     Food manufacturing (NAICS code 311).
     Pesticide manufacturing (NAICS code 32532).

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

    You may access a frequently updated electronic version of EPA's
tolerance regulations at 40 CFR part 180 through the Federal Register
Office's e-CFR site at https://www.ecfr.gov/current/title-40.

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

    Under FFDCA section 408(g), 21 U.S.C. 346a, any person may file an
objection to any aspect of this regulation and may also request a
hearing on those objections. You must file your objection or request a
hearing on this regulation in accordance with the instructions provided
in 40 CFR part 178. To ensure proper receipt by EPA, you must identify
docket ID number EPA-HQ-OPP-2021-0646 in the subject line on the first
page of your submission. All objections and requests for a hearing must
be in writing and must be received by the Hearing Clerk on or before
September 8, 2023. Addresses for mail and hand delivery of objections
and hearing requests are provided in 40 CFR 178.25(b).
    In addition to filing an objection or hearing request with the
Hearing Clerk as described in 40 CFR part 178, please submit a copy of
the filing (excluding any Confidential Business Information (CBI)) for
inclusion in the public docket. Information not marked confidential
pursuant to 40 CFR part 2 may be disclosed publicly by EPA without
prior notice. Submit the non-CBI copy of your objection or hearing
request, identified by docket ID number EPA-HQ-OPP-2021-0646, by one of
the following methods:
     Federal eRulemaking Portal: https://www.regulations.gov.
Follow the online instructions for submitting comments. Do not submit
electronically any information you consider to be CBI or other
information whose disclosure is restricted by statute.
     Mail: OPP Docket, Environmental Protection Agency Docket
Center (EPA/DC), (28221T), 1200 Pennsylvania Ave. NW, Washington, DC
20460-0001.
     Hand Delivery: To make special arrangements for hand
delivery or delivery of boxed information, please follow the
instructions at https://www.epa.gov/dockets/contacts.html.
    Additional instructions on commenting or visiting the docket, along
with more information about dockets generally, is available at https://www.epa.gov/dockets.

II. Summary of Petitioned-For Tolerance

    In the Federal Register of February 25, 2022 (87 FR 10760) (FRL-
9410-01-OCSPP), EPA issued a document pursuant to FFDCA section
408(d)(3), 21 U.S.C. 346a(d)(3), announcing the filing of a pesticide
petition (PP 1E8949) by Nichino America, Inc. 4550 Linden Hill Road,
Suite 501, Wilmington, DE 19808. The petition requested that 40 CFR
part 180 be amended by establishing tolerances for residues of the
insecticide benzpyrimoxan, including its metabolites and degradates, in
or on the raw agricultural commodity rice, grain at 0.9 parts per
million (ppm). The requested tolerance is for food imported into the
U.S. and it is not registered for use in the U.S. That document
referenced a summary of the petition prepared by Nichino America, Inc.,
the registrant, which is available in the docket, https://www.regulations.gov. One comment was received on the notice of filing.
EPA's response to the comment is discussed in Unit IV.C.
    Based upon review of the data supporting the petition, EPA is
revising the tolerance commodity definition for the requested tolerance
in/on rice, grain and is also establishing tolerances for rice,
polished rice and rice, bran. The reason for these changes is explained
in Unit IV.D.

III. Aggregate Risk Assessment and Determination of Safety

    Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish a
tolerance (the legal limit for a pesticide chemical residue in or on a
food) only if EPA determines that the tolerance is ``safe''. Section
408(b)(2)(A)(ii) of FFDCA defines ``safe'' to mean that ``there is a
reasonable certainty that no harm will result from aggregate exposure
to the pesticide chemical residue, including all anticipated dietary
exposures and all other exposures for which there is reliable
information''. This includes exposure through drinking water and in
residential settings but does not include occupational exposure.
Section 408(b)(2)(C) of FFDCA requires EPA to give special
consideration to exposure of infants and children to the pesticide
chemical residue in establishing a tolerance and to ``ensure that there
is a reasonable certainty that no harm will result to infants and
children from aggregate exposure to the pesticide chemical residue. . .
.''

    Consistent with FFDCA section 408(b)(2)(D), and the factors
specified in FFDCA section 408(b)(2)(D), EPA has reviewed the available
scientific data and other relevant information in support of this
action. EPA has sufficient data to assess the hazards of and to make a
determination on aggregate exposure for benzpyrimoxan including
exposure resulting from the tolerances established by this action.
EPA's assessment of exposures and risks associated with benzpyrimoxan
follows.

A. Toxicological Profile

    EPA has evaluated the available toxicity data and considered its
validity, completeness, and reliability as well as the relationship of
the results of the studies to human risk. EPA has also considered
available information concerning the variability of the sensitivities
of major identifiable subgroups of consumers, including infants and
children.
    The toxicology database for benzpyrimoxan is complete for the
establishment of a tolerance without U.S. registration. The affected
target organs following the administration of benzpyrimoxan are the
kidney and urinary tract. Crystals were observed in the kidneys and
urinary tract along with tissue damage in both mice and rats following
subchronic and chronic oral administration. The rat appeared to be the
most sensitive species tested, with mouse and dog having similar
toxicity. There did not appear to be a difference in toxicity by sex in
any species.
    Increased quantitative susceptibility was seen in the rabbit
preliminary developmental study where decreases in fetal body weight
were observed in the absence of adverse maternal toxicity. There was no
evidence of increased quantitative or qualitative lifestage
susceptibility in the definitive rat or rabbit developmental toxicity
or in the preliminary rat developmental toxicity. Increased qualitative
susceptibility in the form of mortality (post-implantation loss and
decreased viability index) was seen in the reproductive toxicity study
in rats. The concern for increased susceptibility is low as there were
clear lowest-observed-adverse-effect-levels (LOAELs) and no-observed-
adverse-effect-levels (NOAELs) in the developmental and reproductive
toxicity studies and the points of departure (PODs) are protective of
the increased susceptibility. There was no evidence of treatment-
related tumors in the rat or mouse carcinogenicity studies and all of
the mutagenicity studies were negative.
    Benzpyrimoxan is classified as: ``Not likely to be carcinogenic to
humans'' based on lack of treatment-related tumors in long-term dietary
studies in the rat and mouse and low concern for genotoxicity. No
treatment-related increase in the incidence of tumors was observed in
carcinogenicity studies in rats or mice. Additionally, there is no
evidence of mutagenicity in vivo or in vitro.
    Toxicity data were submitted for the benzpyrimoxan metabolite DH-04
in the form of a 90-day oral toxicity study in rats. In this study,
kidney effects and urine effects were observed in males and females at
65 and 78 mg/kg/day, respectively. Mortality was observed at the
highest dose tested (168/181 mg/kg/day [M/F]), and histopathological
evaluation revealed various cardiovascular and/or renal lesions. By
comparing the effects at the LOAEL for this study to the parent 90-day
oral rat study, it is estimated that DH-04 is approximately 3X more
toxic than the parent compound. Consequently, a 3X potency factor for
DH-04 will be used when conducting the dietary exposure assessment.
    Specific information on the studies received and the nature of the
adverse effects caused by benzpyrimoxan as well as the no-observed-
adverse-effect-level (NOAEL) and the lowest-observed-adverse-effect-
level (LOAEL) from the toxicity studies can be found at https://www.regulations.gov in document ``Benzpyrimoxan: First Food Use; Human
Health Risk Assessment to Support the Establishment of a Tolerance
without U.S. Registration in/on Rice'' hereinafter ``Benzpyrimoxan
Human Health Risk Assessment'' at page 24 in docket ID number EPA-HQ-
OPP-2021-0646.

B. Toxicological Points of Departure/Levels of Concern

    Once a pesticide's toxicological profile is determined, EPA
identifies toxicological points of departure (POD) and levels of
concern to use in evaluating the risk posed by human exposure to the
pesticide. For hazards that have a threshold below which there is no
appreciable risk, the toxicological POD is used as the basis for
derivation of reference values for risk assessment. PODs are developed
based on a careful analysis of the doses in each toxicological study to
determine the dose at which no adverse effects are observed (the NOAEL)
and the lowest dose at which adverse effects of concern are identified
(the LOAEL). Uncertainty/safety factors are used in conjunction with
the POD to calculate a safe exposure level--generally referred to as a
population-adjusted dose (PAD) or a reference dose (RfD)--and a safe
margin of exposure (MOE). For non-threshold risks, the Agency assumes
that any amount of exposure will lead to some degree of risk. Thus, the
Agency estimates risk in terms of the probability of an occurrence of
the adverse effect expected in a lifetime. For more information on the
general principles EPA uses in risk characterization and a complete
description of the risk assessment process, see https://www.epa.gov/pesticide-science-and-assessing-pesticide-risks/assessing-human-health-risk-pesticides.
    A summary of the toxicological endpoints for benzpyrimoxan used for
human risk assessment can be found in the Benzpyrimoxan Human Health
Risk Assessment on pages 15-16.

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary
exposure to benzpyrimoxan, EPA considered exposure under the
petitioned-for tolerances. EPA assessed dietary exposures from
benzpyrimoxan in food as follows:
    i. Acute exposure. Quantitative acute dietary exposure and risk
assessments are performed for a food-use pesticide, if a toxicological
study has indicated the possibility of an effect of concern occurring
as a result of a 1-day or single exposure. No such effects were
identified in the toxicological studies for benzpyrimoxan; therefore, a
quantitative acute dietary exposure assessment is unnecessary.
    ii. Chronic exposure. In conducting the chronic dietary exposure
assessment, EPA used 2005-2010 food consumption data from the U.S.
Department of Agriculture's National Health and Nutrition Examination
Survey, What We Eat in America (NHANES/WWEIA). As to residue levels in
food, EPA used tolerance-level residues (or higher to account for
additional residues of concern), default processing factors, and 100
percent crop treated (PCT) assumptions.
    iii. Cancer. EPA determines whether quantitative cancer exposure
and risk assessments are appropriate for a food-use pesticide based on
the weight of the evidence from cancer studies and other relevant data.
Based on the data summarized in Unit III.A., EPA has concluded that
benzpyrimoxan does not pose a cancer risk to humans due to absence of
treatment-related tumors or evidence of mutagenicity in the available
studies. Therefore, a dietary exposure assessment for the purpose of
assessing cancer risk is unnecessary.
    iv. Anticipated residue and percent crop treated (PCT) information.
EPA did not use anticipated residue and/or PCT

information in the dietary assessment for benzpyrimoxan. Tolerance
level residues (or higher to account for additional residues of
concern), default processing factors, and 100 PCT were assumed for all
food commodities.
    2. Dietary exposure from drinking water. EPA assumes that there is
no exposure through drinking water because benzpyrimoxan is not
registered for use in the United States. Because residues are not
expected in drinking water, dietary risk estimates include exposures
from food only.
    3. From non-dietary exposure. The term ``residential exposure'' is
used in this document to refer to non-occupational, non-dietary
exposure (e.g., for lawn and garden pest control, indoor pest control,
termiticides, and flea and tick control on pets). Benzpyrimoxan is not
registered for any specific use patterns that would result in
residential exposure.
    4. Cumulative effects from substances with a common mechanism of
toxicity. Section 408(b)(2)(D)(v) of FFDCA requires that, when
considering whether to establish, modify, or revoke a tolerance, the
Agency consider ``available information'' concerning the cumulative
effects of a particular pesticide's residues and ``other substances
that have a common mechanism of toxicity.''
    Unlike other pesticides for which EPA has followed a cumulative
risk approach based on a common mechanism of toxicity, EPA has not made
a common mechanism of toxicity finding as to benzpyrimoxan and any
other substances. In addition, benzpyrimoxan does not appear to produce
a toxic metabolite produced by other substances. For the purposes of
this action, therefore, EPA has not assumed that benzpyrimoxan has a
common mechanism of toxicity with other substances.

D. Safety Factor for Infants and Children

    1. In general. Section 408(b)(2)(C) of FFDCA provides that EPA
shall apply an additional tenfold (10X) margin of safety for infants
and children in the case of threshold effects to account for prenatal
and postnatal toxicity and the completeness of the database on toxicity
and exposure unless EPA determines based on reliable data that a
different margin of safety will be safe for infants and children. This
additional margin of safety is commonly referred to as the FQPA Safety
Factor (SF). In applying this provision, EPA either retains the default
value of 10X, or uses a different additional safety factor when
reliable data available to EPA support the choice of a different
factor.
    2. Prenatal and postnatal sensitivity. There was no evidence of
increased quantitative or qualitative lifestage susceptibility in the
definitive rat or rabbit developmental toxicity or in the preliminary
rat developmental toxicity. However, in the preliminary rabbit
developmental study, which tested up to a higher dose than the
definitive study (30 mg/kg/day), decreased fetal body weights were
observed at 60 mg/kg/day in the absence of adverse maternal effects.
Marginal body-weight decreases associated with marked food consumption
decreases were observed in the maternal animals in this study, but they
did not reach adversity.
    In the two-generation reproduction study, the parental animals had
gross (depressed areas) and histopathological (pelvic crystals and
obstructive nephropathy) effects in the kidneys of P and F1 generation
males. Degenerative necrosis and hepatocyte centrilobular hypertrophy
associated with increased liver weights were also observed in the
parental generation. In the offspring F1 and F2 generations, increased
incidences of mortality and decreases in pup body weight were observed.
Increased incidence of post-implantation loss and decreased viability
indices early during lactation at the same dose as that eliciting
parental effects were considered to be both offspring and reproductive
effects and indicated increased qualitative susceptibility.
    3. Conclusion. EPA has determined that reliable data show the
safety of infants and children would be adequately protected if the
FQPA SF were reduced from 10X to 1X. That decision is based on the
following findings:
    i. The toxicity database for benzpyrimoxan is complete for
evaluating and characterizing toxicity, assessing pre- and postnatal
susceptibility under FQPA, and selecting endpoints for the anticipated
exposure pathways. Developmental toxicity studies in the rat and rabbit
and a two-generation reproductive toxicity study in the rat are
available, in addition to an acute neurotoxicity study.
    ii. There is no evidence of neurotoxicity in the benzpyrimoxan
database including an acute neurotoxicity study which tested up to the
limit dose and functional observation batteries and motor activity
observations performed in the 90-day and combined chronic/
carcinogenicity rat studies. EPA has waived both the subchronic
neurotoxicity and immunotoxicity studies at this time.
    iii. As stated above, no evidence of increased quantitative or
qualitative lifestage susceptibility was seen in the definitive rat and
rabbit developmental studies, as there were no maternal or
developmental adverse effects in those studies. In the preliminary
rabbit developmental study, which tested up to a higher dose (60 mg/kg/
day) than the definitive study (30 mg/kg/day), adverse fetal body
weights were observed in the absence of adverse maternal effects,
suggesting quantitative susceptibility at >=60 mg/kg/day. Transient
body-weight decreases and marked decreases in food consumption during
treatment were observed in maternal animals at this dose but were not
considered to reach adversity; however, based on the findings at the
highest dose tested (60 mg/kg/day) it is unlikely that the maternal
animals could have tolerated much higher dosing given those
observations. In the two-generation reproduction toxicity study,
parental toxicity (kidney and liver effects) was observed at the same
dose as offspring (mortality, decreases in body weight, post-
implantation loss, and decreased viability indices) and reproductive
(post-implantation loss and decreased viability indices) effects. The
concern for susceptibility observed in the preliminary developmental
study in rabbits is low as the effects in the maternal animals
approached adversity. Additionally, there is a clear NOAEL established
for developmental effects in that study and the offspring and
reproductive effects in the two-generation reproduction study, and the
PODs selected for risk assessment are protective of the observed
quantitative and qualitative susceptibility in those two studies.
    iv. There are no residual uncertainties identified in the exposure
databases. An unrefined dietary exposure assessment was completed
(tolerance level residues (or higher to account for additional residues
of concern), default processing factors, and 100 PCT were assumed). In
addition, there are no proposed or registered uses that would result to
residential exposures. These assessments will not underestimate the
exposure and risks posed by benzpyrimoxan.

E. Aggregate Risks and Determination of Safety

    EPA determines whether acute and chronic dietary pesticide
exposures are safe by comparing dietary exposure estimates to the acute
PAD (aPAD) and chronic PAD (cPAD). Short-, intermediate-, and chronic-
term

aggregate risks are evaluated by comparing the estimated total food,
water, and residential exposure to the appropriate PODs to ensure that
an adequate MOE exists.
    1. Acute risk. An acute aggregate risk assessment takes into
account acute exposure estimates from dietary consumption of food and
drinking water. No adverse effect resulting from a single oral exposure
was identified and no acute dietary endpoint was selected. Therefore,
benzpyrimoxan is not expected to pose an acute risk.
    2. Chronic risk. Using the exposure assumptions described in this
unit for chronic exposure, EPA has concluded that chronic exposure to
benzpyrimoxan from food only will utilize less than (<) 1% of the cPAD
for all infants (<1 year old), the subpopulation with the highest risk
estimate. There are no residential uses for benzpyrimoxan.
    3. Short- and intermediate- term risk. Short- and intermediate-term
aggregate exposure takes into account short- and intermediate-term
residential exposure plus chronic exposure to food and water
(considered to be a background exposure level). Because benzpyrimoxan
is not registered in the United States, the only exposures will be
dietary from residues in or on imported rice; therefore, no short-term
or intermediate-term residential exposure is expected. Because there is
no short- or intermediate-term residential exposure and chronic dietary
exposure has already been assessed under the appropriately protective
cPAD (which is at least as protective as the POD used to assess short-
term risk), no further assessment of short- or intermediate-term risk
is necessary, and EPA relies on the chronic dietary risk assessment for
evaluating short- and intermediate-term risk for benzpyrimoxan.
    5. Aggregate cancer risk for U.S. population. Based on the lack of
evidence of carcinogenicity in two adequate rodent carcinogenicity
studies, benzpyrimoxan is not expected to pose a cancer risk to humans.
    6. Determination of safety. Based on these risk assessments, EPA
concludes that there is a reasonable certainty that no harm will result
to the general population, or to infants and children from aggregate
exposure to benzpyrimoxan residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    Adequate enforcement methodology (Smithers Method 14078.6140, a
QuEChERS based liquid chromatography with tandem mass spectrometry (LC-
MS/MS) multi-residue method) is available to enforce the tolerance
expression.
    The method may be requested from: Chief, Analytical Chemistry
Branch, Environmental Science Center, 701 Mapes Rd., Ft. Meade, MD
20755-5350; telephone number:<PHONE_NUMBER>; email address:
[email protected].

B. International Residue Limits

    In making its tolerance decisions, EPA seeks to harmonize U.S.
tolerances with international standards whenever possible, consistent
with U.S. food safety standards and agricultural practices. EPA
considers the international maximum residue limits (MRLs) established
by the Codex Alimentarius Commission (Codex), as required by FFDCA
section 408(b)(4). The Codex Alimentarius is a joint United Nations
Food and Agriculture Organization/World Health Organization food
standards program, and it is recognized as an international food safety
standards-setting organization in trade agreements to which the United
States is a party. EPA may establish a tolerance that is different from
a Codex MRL; however, FFDCA section 408(b)(4) requires that EPA explain
the reasons for departing from the Codex level.
    The Codex has not established a MRL for benzpyrimoxan.

C. Response to Comments

    One comment was received in response to the Notice of Filing. The
comment stated that ``there is still a lot we do not know about many of
the chemicals we utilize and ingestion of these chemicals is not likely
beneficial. Gathering that we should limit potential exposure to these
by consumers as much as possible, why was the petition made to grant an
exemption or tolerance? What is the user's or manufacturer's reasoning
to request the allowance of more of these chemicals to remain on
produce and potentially be ingested, and should more long-term
information be acquired on the chemicals before allowing such a
decision to be made?''
    Although the Agency recognizes that some individuals believe
pesticides should be more restricted on agricultural crops, the
existing legal framework provided by section 408 of the FFDCA
authorizes EPA to establish tolerances when it determines that the
tolerance is safe. Upon consideration of the validity, completeness,
and reliability of the available data as well as other factors the
FFDCA requires EPA to consider, EPA has determined that benzpyrimoxan
tolerances are safe. The commenter has provided no information
indicating that a safety determination cannot be supported.

D. Revisions to Petitioned-For Tolerances

    Although the petitioner requested a tolerance for ``rice, grain'',
EPA is establishing tolerances for ``rice, husked'', ``rice, polished
rice'', and ``rice, bran''. Each of these commodities is a processed
form of the ``rice, grain'' raw agricultural commodity that was
requested. Consistent with its authority to establish tolerances that
vary from what was requested under section 408(d)(4)(A)(i) of the
FFDCA, EPA is establishing tolerances that align better with the
Agency's current preferred commodity vocabulary and with the actual
form of the commodities that may be imported into the United States. In
addition, the available residue data indicate that separate tolerances
are needed for the processed commodities of ``rice, polished rice'' and
``rice, bran'' due to the concentration of residues.

V. Conclusion

    Therefore, tolerances are established for residues of
benzpyrimoxan, including its metabolites and degradates, in or on rice,
husked at 0.9 ppm; rice, polished rice at 0.15 ppm; and rice, bran at 3
ppm.

VI. Statutory and Executive Order Reviews

    This action establishes tolerances under FFDCA section 408(d) in
response to a petition submitted to the Agency. The Office of
Management and Budget (OMB) has exempted these types of actions from
review under Executive Order 12866, entitled ``Regulatory Planning and
Review'' (58 FR 51735, October 4, 1993). Because this action has been
exempted from review under Executive Order 12866, this action is not
subject to Executive Order 13211, entitled ``Actions Concerning
Regulations That Significantly Affect Energy Supply, Distribution, or
Use'' (66 FR 28355, May 22, 2001) or Executive Order 13045, entitled
``Protection of Children from Environmental Health Risks and Safety
Risks'' (62 FR 19885, April 23, 1997). This action does not contain any
information collections subject to OMB approval under the Paperwork
Reduction Act (PRA) (44 U.S.C. 3501 et seq.), nor does it require any
special considerations under Executive Order 12898, entitled ``Federal
Actions to Address Environmental Justice in Minority Populations and
Low-Income

Populations'' (59 FR 7629, February 16, 1994).
    Since tolerances and exemptions that are established on the basis
of a petition under FFDCA section 408(d), such as the tolerances in
this final rule, do not require the issuance of a proposed rule, the
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et
seq.), do not apply.
    This action directly regulates growers, food processors, food
handlers, and food retailers, not States or tribes, nor does this
action alter the relationships or distribution of power and
responsibilities established by Congress in the preemption provisions
of FFDCA section 408(n)(4). As such, the Agency has determined that
this action will not have a substantial direct effect on States or
tribal governments, on the relationship between the national government
and the States or tribal governments, or on the distribution of power
and responsibilities among the various levels of government or between
the Federal Government and Indian tribes. Thus, the Agency has
determined that Executive Order 13132, entitled ``Federalism'' (64 FR
43255, August 10, 1999) and Executive Order 13175, entitled
``Consultation and Coordination with Indian Tribal Governments'' (65 FR
67249, November 9, 2000) do not apply to this action. In addition, this
action does not impose any enforceable duty or contain any unfunded
mandate as described under Title II of the Unfunded Mandates Reform Act
(UMRA) (2 U.S.C. 1501 et seq.).
    This action does not involve any technical standards that would
require Agency consideration of voluntary consensus standards pursuant
to section 12(d) of the National Technology Transfer and Advancement
Act (NTTAA) (15 U.S.C. 272 note).

VII. Congressional Review Act

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

List of Subjects in 40 CFR Part 180

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

    Dated: June 30, 2023.
Daniel Rosenblatt,
Acting Director, Office of Pesticide Programs.

    Therefore, 40 CFR chapter I is amended as follows:

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

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

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

0
2. Add Sec.  180.724 to subpart C to read as follows:

Sec.  180.724  Benzpyrimoxan; tolerances for residues.

    (a) General. Tolerances are established for residues of
benzpyrimoxan, including its metabolites and degradates, in or on the
commodities in Table 1 to this paragraph (a). Compliance with the
tolerance levels specified in Table 1 to this paragraph (a) is to be
determined by measuring residues of benzpyrimoxan (5-(1,3-dioxan-2-yl)-
4-[[4-(trifluoromethyl)phenyl]methoxy]pyrimidine) in or on the
following commodities:

                        Table 1 to Paragraph (a)
------------------------------------------------------------------------
                                                             Parts per
                        Commodity                             million
------------------------------------------------------------------------
Rice, husked \1\........................................             0.9
Rice, polished rice \1\.................................            0.15
Rice, bran \1\..........................................               3
------------------------------------------------------------------------
\1\ There are no U.S. registrations as of July 10, 2023.

    (b)-(d) [Reserved]

[FR Doc. 2023-14404 Filed 7-7-23; 8:45 am]
BILLING CODE 6560-50-P