Interregional Research Project Number 4 ( IR 4)

2E6438 EPA has received a pesticide petition ([ 2E6438]) from [ Interregional Research Project Number 4 ( IR 4), Rutgers, The State University of New Jersey, 681 U. S. Highway No. 1 South, North New Brunswick, NJ 08902, proposing, pursuant to section 408( d) of the Federal Food, Drug, and Cosmetic Act ( FFDCA), 21 U. S. C. 346a( d), to amend 40 CFR part 180 by establishing a tolerance for residues of diuron, ( 3( 3,4 dichlorophenyl) 1,1 dimethylurea) in or on the raw agricultural commodities mint at 2.0 parts per million ( ppm). EPA has determined that the petition contains data or information regarding the elements set forth in section 408( d)( 2) of the FFDCA; however, EPA has not fully evaluated the sufficiency of the submitted data at this time or whether the data supports granting of the petition. Additional data may be needed before EPA rules on the petition.

A. Residue Chemistry 1. Plant metabolism. The metabolism of diuron in plants and animals from the results of wheat, corn, orange, ruminant, and poultry studies together with the environmental fate studies conducted in soil and water and has identified the following 14C containing residues in plants: diuron, 3,4 dichlorophenylurea ( DCPU), and 3( 3,4 dichlorophenyl) 1 methylurea ( DCPMU). No other dichloroaniline containing metabolites were identified. The majority of radioactivity in the aqueous/ organic fractions was characterized as polar unknowns. Radiovalidation of a GC/ ECD data collection method, which is similar to the enforcement method, suggested that a good portion of these polar metabolites can be converted to 3,4 DCA.

2. Analytical method. An analytical method is available, a modified form of DuPont Agricultural Products method # 5470. The principle of the determination is the hydrolysis of diuron and its metabolites by alkaline reflux to 3,4 dichloroanaline ( 3,4 DCA), followed by a distillation of the aniline into an acid solution. The acid distillate is made alkaline with concentrated base and subsequently extracted into an organic solvent ( hexane) and analyzed by gas chromatography. With the modified method, recoveries exceeded 70% and the limit of quantitation ( LOQ) is 0.01 < greek m> g/ g.

3. Magnitude of residues. One field trial was conducted on a 9 ½ year oil mint field with a loam soil type. Treatments were made on April 7, 1993 using a CO2 backpack sprayer equipped with 6 Flat Fan 8003 nozzles. Treatments consisted of a 1x rate of 2.4 lb active, 1.5x rate of 3.6 lb active, and a 2x rate of 4.8 lb active. Control plots were located 800 feet away from treated plots in the same field. The mint was cut on August 9 and allowed to dry in the field until August 11 or 12 for collection. Control plants were collected on August 11 and a portion of the samples were distilled into oil on the same day. Plants from plots treated with the 3.6 lb active rate of diruon were collected on August 12 and distilled into oil on the same day. The protocol specified to collect samples from the highest rate that did not result in excessive herbicide injury to the mint plants. Samples were processed into oil within 4 hours of collection. All samples were placed in frozen storage at 0 F until being shipped by ACDS freezer truck on August 20, 1993. All samples were received frozen at the laboratory and retained in frozen storage. Bulk forage samples were ground with dry ice and returned to frozen storage. One freezer failure was reported, however, the maximum temperature recorded was  13 C. The maximum period from harvest to analysis was 641 days. The method used for analysis was: Morse Laboratories, Inc. SOP# Meth 65, Revision # 3, " Determination of Substituted Urea Herbicides, Linuron, Diuron, and their metabolites in Soil and Agricultural Products", August 1993. Method validation recoveries at 0.05, 0.5, and 5.0 ppm, ranged from 64 to 73% ( averaging 70% n= 11) on hay and ranged from 77 to 90% ( averaging 81% n= 9) on mint oil. Two recovery samples were extracted and analyzed concurrently with the field treated samples, concurrent recovery for hay samples were 71 to 73% for 0.05 and 5.0, respectively and 81 and 77% at 0.05 and 0.5 ppm, respectively, for oil samples. No diuron residues were recovered at or above the reliable limit of quantitation of 0.05 ppm, from any of the control forage or oil samples. Residue in the treated forage samples ranged from 0.143 to 0.212 ppm and from 0.0605 to 0.0619 ppm in the oil samples. Therefore, diuron residues did not concentrate when the mint samples were distilled into oil. The nature of the residues is adequately understood and an adequate analytical method is available for enforcement purposed. Based on the above information, retaining this tolerance would protect the public health and would not expose man or the environment to unreasonable adverse effects.

B. Toxicological Profile 1. Acute toxicity. Diuron has low acute toxicity ( Toxicity Category 3 or 4) by the oral, dermal, or inhalation exposure routes. Diuron is not an eye or skin irritant, and not a skin sensitizer. A rat metabolism study indicated that diuron is rapidly absorbed and metabolized within 24 hours post dose at the low dose and within 48 hours post dose at the high dose. The urine is the major route of excretion in both sexes. A small amount of diuron is detected in the feces. The highest tissue residue levels were found in the liver and kidneys 4 days post 14C diuron dose. The metabolism of diuron involved N oxidation, some ring hydroxylation, demethylation, dechlorination, and conjugation to sulfate and glucuronic acid.

2. Genotoxicty.

i. Salmonella typhimurium reverse gene mutation assay ( MRID# 00146608/ 40228805): Independent trials were negative.

ii. Chinese Hamster Ovary ( CHO)/ HGPRT) cell forward gene mutation assay ( MRID# 00146609): Independent tests were negative up to cytotoxic doses with/ without S9 activation. 3. Reproductive and developmental toxicity. There is an acceptable developmental toxicity study in rabbits and an acceptable two generation reproduction study in rats. A developmental toxicity study in rats was classified as unacceptable due to deficiencies in analytical data on the sample analysis; however, the Agency considered the developmental toxicity study in rats adequate for the FQPA susceptibility assessment based on the observation that the developmental toxicity NOAEL was higher than the maternal NOAEL and concluded that a developmental neurotoxicity ( DNT) study is not required. There is no indication of increased susceptibility to young exposed to diuron in the available studies. In the developmental toxicity study in rabbits, there were no developmental effects at the highest dose tested. In the developmental toxicity study in rabbits and in the 2 generation rat reproduction study, developmental/ offspring effects were observed only at maternally/ parentally toxic dose levels.

4. Subchronic toxicity. The primary diuron target sites are blood, bladder, and kidney. Erythrocyte ( red blood cell) damage resulted in hemolytic anemia and compensatory hematopoiesis, which are manifested as significantly decreased erythrocyte counts, hemoglobin levels, and hematocrit, and increased mean corpuscular volume ( MCV), mean corpuscular hemoglobin ( MCH), abnormal erythrocyte forms, reticulocyte counts, and leukocyte count. Consistent observations of erythocytic regeneration are seen in chronic toxicity studies in rats, mice and dogs. Gross pathology findings in chronic rat and mouse studies showed increased incidences of urinary bladder swelling and wall thickening at high doses. Microscopic evaluation showed dose related increases in the severity of epithelial focal hyperplasia of the urinary bladder and renal pelvis ( kidney) in both sexes. Although the developmental toxicity study in rats is classified as unacceptable, the database as a whole is adequate for pre and post natal toxicity evaluation and did not reveal developmental or reproductive toxicity. The NOAELs for maternal/ parental toxicity were either less than or equal to the NOAELs for fetal or reproductive toxicity. A complete summary of the toxicity database is discussed in the document titled " Diuron  Phase 2: Revised Toxicology Disciplinary Chapter for the Reregistration Eligibility Decision," dated March 6, 2002.

5. Chronic toxicity.

EPA has established the RfD for diuron at 0.003 mg/ kg/ day. This RfD is based on a 2 year chronic feeding/ oncogenicity study in the rat with a LOAEL of 1.02 mg/ kg/ day and an uncertainty factor ( UF) of 300 ( additional UP of 3 for the use of a LOAEL) based on decreased erythrocyte count in females, increased hemodiderin in the spleen, increased spleen weight, bone marrow activation, increased hematopoietic marrow, decreased fat marrow (% surface area of fat marrow in bone marrow) and thickened urinary bladder wall in males.

6. Animal metabolism. Livestock Commodities: The 14C containing residues that were identified in lactating goats were as follows. The principal residue identified was DCPU which comprised 10% of TRR in milk, 27% of TRR in fat, 35% of TRR in kidney, 23% of TRR in liver, and 22% of TRR in muscle. The parent and other dichloroaniline containing metabolites ( i. e., 3,4 DCA and DCPMU) were detected in trace quantities ( 0.01 ppm each) except in liver ( 0.12 ppm). Four minor ( each 6% of TRR) hydroxylated metabolites ( 2 OH DCA; 2 OH DCPU; 2 OHDCPMU; and N acetyl 2 OH DCA) were also detected; these metabolites were not observed in plants and would not be determined by the enforcement method. The major portion of radioactive residues in milk was comprised of several conjugated polar components which collectively accounted for 56% of TRR. These polar components also accounted for substantial portions of the total radioactivity in liver ( collectively 25% of TRR) and kidney ( collectively 23% of TRR). Attempts to further elucidate the nature of these polar materials using various techniques ( e. g., enzyme digestions, heat treatment) were not successful.

Poultry: The 14C containing residues that were identified in laying hens were as follows. DCPU, which comprised 45% of TRR in liver, 67 75% of TRR in muscle, 47% of TRR in skin with fat, 57% of TRR in egg yolk, and 54% of TRR in egg white. The parent, other dichloroaniline containing metabolites ( i. e., DCPMU), and hydroxylated metabolites ( 2 OH diuron, 2 OH DCA, 2 OH DCPU, 2 OHDCPMU, and N acetyl 2 OH DCA) were identified only in trace quantities ( mostly at 0.01 ppm each). Adequate radiovalidation data were submitted for the proposed enforcement method for animal commodities. The GC method recovered 86 to > 100% of the TRR in liver, kidney, and muscle; however, the method recovered only 10% of the TRR in milk and 25% of the TRR in fat. The low recovery in milk was previously addressed ( DP Barcodes D195058 and D195068, 11/ 30/ 93, R. Perfetti). It was concluded that because the major portion of radioactive residues in milk appear to be hydroxy metabolites, which cannot be converted to DCA and do need not be quantitated, a new method would not be required for milk. Instead, it was determined that the levels of diuron residues in milk identified in the ruminant feeding study would be multiplied by 10 to account for all of the exposure in the risk assessment. The low recovery in fat was most likely due to the low residue levels present in fat. In a separate radiovalidation study, the GC method recovered 62 to 77% of the TRR in poultry liver and muscle, and 58 to 65% of the TRR in egg whites and yolks.

7. Metabolite toxicology. A rat metabolism study indicated that diuron is rapidly absorbed and metabolized within 24 hours post dose at low dose and within 48 hours post dose at high dose. The urine is the major route of excretion in both sexes. A small amount of diuron is detected in the feces. No apparent difference was observed between single and multiple low oral doses. There was no apparent sex related difference in either absorption or elimination. Metabolism of diuron involved Noxidation ring hydroxylation, demethylation, dechlorination, and conjugation to sulfate and glucuronic acid. The major urine metabolite was IN R915 ( 3,4 dichlorophenylurea), which accounted for > 20% of the total administered dose. Other metabolites were glucuronide conjugates, sulfate conjugates and free metabolites.

8. Endocrine disruption. At this time, neither the available submitted studies on diuron nor the literature show any indication of endocrine disruption effects. C. Aggregate Exposure 1. Dietary exposure. There are no adverse effects attributed to a single exposure identified in any available studies. In addition, diuron has low acute toxicity and no developmental or neurotoxic concerns. Therefore, no acute dietary endpoint was chosen and no acute dietary risk assessment was conducted. Diuron is a preplant, pre or post emergent herbicide, used on a variety of fruits, vegetables, nuts and field crops. Tolerances are established for residues of diuron in or on food commodities at levels ranging from 0.1 ppm to 7 ppm ( 40 CFR 180.106).

i. Food. Estimated chronic dietary ( food) risk estimates associated with the use of diuron do not exceed the Agency's level of concern (> 100% cPAD) for any population subgroup including the most highly exposed population subgroup, children ages 1 6 years. The chronic dietary risk for children ages 1 6 years is 7% of the chronic PAD and 3% for the general U. S. population. Orange juice and orange juice concentrate are the largest contributors to dietary exposure from diuron. The estimated cancer dietary risk associated with the use of diuron indicates a borderline exceedance above 1 x 10 6 ( i. e., probability greater than one in one million) and shows a lifetime risk estimate of 1.68 x 10 6 for the general population but is not of concern. There are no adverse effects attributed to a single exposure identified in any available studies. In addition, diuron has low acute toxicity and no developmental or neurotoxic concerns. Therefore, no acute dietary endpoint was chosen and no acute dietary risk assessment was conducted.

ii. Drinking water. Environmental laboratory studies have shown that in drinking water only, diuron partially degrades to another chemical referred to as MCPDMU ( N'( 3 chlorophenyl) N, Ndimethyl urea). However, the environmental fate and persistence of MCPDMU are uncertain. MCPDMU is structurally similar to monuron [ N'( 4 chlorophenyl) N, N dimethyl urea], a pesticide no longer registered in the United States. Monuron produces tumors in the kidney and liver in male rats and has a Q1* of 1.52 x 10 2. Due to the structural similarity between MCPDMU and monuron, the Agency believes it is prudent to evaluate the carcinogenic risk associated with MCPDMU based upon the hazard information concerning the chemical monuron. The Agency believes MCPDMU is likely less toxic than monuron, but is unable to quantify this difference without further information. The approach used in this assessment yields a high end estimate. Absent information specifically about the carcinogenic potential of MCPDMU, the Agency has taken this conservative, health protective approach in its assessment. The Agency is addressing this uncertainty by requiring additional information about the behavior and fate of diuron and its drinking water degradate, MCPDMU. Two separate cancer risk assessments were completed for diuron and MCPDMU ( N'( 3 chlorophenyl) N, N dimethyl urea), a degradate of diuron in water only. Because the cancer effects ( i. e., target organs) for the two compounds differ, the risks from diuron and MCPDMU are not combined. Based on a Q1* of a similar compound, monuron, the estimated dietary risk for MCPDMU is 1.02 x 10 7, which includes catfish consumption only. The anticipated residue of MCPDMU in catfish was calculated using the 2 ppm tolerance for catfish, the fraction of applied radioactive diuron converted to MCPDMU in an aerobic aquatic metabolism study and the percent crop treated for catfish. Neither diuron nor monuron are regulated under the Safe Drinking Water Act. As a result, neither Maximum Contaminant Levels ( MCLs) nor drinking water health advisories ( HAs) for these chemicals have been established by the EPA Office of Water. However, diuron was placed on a list of contaminants to be monitored during 2001 and 2002. This information will be used to support EPA decisions concerning whether or not to regulate and establish standards for diuron in drinking water.]

2. Non dietary exposure. Because of the low percent of paint containing diuron, exposure to home applicators is not likely to be a significant contributor to aggregate risk. Calculated diuron potential cancer risks from food and residential applicator exposure ( paints and stains) show a slight exceedance of the Agency's level of concern, 1 x 10 6. Both assessments include conservative exposure assumptions. In both cases additional data will allow for refinement of the exposure portion of the assessment.]

D. Cumulative Effects EPA did not perform a cumulative risk assessment of diuron because the Agency has not determined that there are any other chemical substances that have a mechanism of toxicity common with that of diuron.

E. Safety Determination 1. U. S. population. In its July, 2002 TRED, EPA determined that the established uses for diuron, with amendments and changes as specified in that document, met the safety standard under the FQPA amendments to section 408( b)( 2)( D) of the FFDCA, that there is a reasonable certainty of no harm for the general population. In reaching this determination, EPA considered all available information on the toxicity, use practices, and scenarios, and the environmental behavior of diuron. An acute dietary risk assessment was not performed because no adverse effects attributed to a single exposure were identified in any available study. For chronic ( non cancer) risk from food alone, the risks from diuron are not of concern. The estimated cancer dietary risk associated with the use of diuron indicates a slight exceedance above 1 x 10 6 and shows a lifetime risk estimate of 1.68 x 10 6 for the general population. However, the Agency has determined that potential dietary cancer risk is not of concern because the residues used in the calculations are from field trials conducted at the highest application rates and some residue processing data are still outstanding. Therefore, the exposure calculation is a conservative estimate. Acute risks from drinking water exposures are not of concern. For chronic drinking water risk, drinking water monitoring data from Florida, California, and the U. S. Geological Survey National Water Quality Assessment ( NAWQA) Program were used to determine the estimated environmental concentrations ( EECs) in surface water. These monitoring data confirm that actual concentrations of diuron are substantially less than previous model estimates. Although modeled estimates showed only a marginal exceedance of the WLOC, monitoring data show 84 concentrations substantially below the chronic DWLOC. Short term residential exposures to diuron are not of concern. The Agency has concluded that the potential cancer risk from residential use is negligible because of the low volume of diuron used in paint and the sporadic, short term duration of homeowner exposures.

2. Infants and children. In its July 2002 TRED, EPA determined that the established tolerances for diuron, meet the safety standards under the FQPA amendments to section 408( b)( 2)( C) of the FFDCA, that there is a reasonable certainty of no harm for infants and children. The safety determination for infants and children considered the factors noted above for the general population, but also takes into account the possibility of increased dietary exposure due to the specific consumption patterns of infants and children, as well as the possibility of increased susceptibility to the toxic effects of diuron residues in this population subgroup. In determining whether or not infants and children are particularly susceptible to toxic effects from diuron residues, EPA considered the completeness of the database for developmental and reproductive effects, the nature of the effects observed, and other information. The FQPA Safety Factor has been removed ( i. e., reduced to 1x) for diuron because: 1) there is no indication of quantitative or qualitative increased susceptibility of rats or rabbits to in utero or postnatal exposure; 2) a DNT study with diuron is not required; and 3) the dietary ( food and drinking water) and non dietary ( residential) exposure assessments will not underestimate the potential exposures for infants and children.]

F. International Tolerances [ The Codex Alimentarius Commission has not established or proposed Codex MRLs for residues of diuron; therefore, there are no issues pertaining to harmonization of U. S. tolerance with Codex MRLs.

Canadian tolerances ( from PMRA web site) include the following: 7 ppm in/ on asparagus 1 ppm in/ on citrus, corn, grapes, pineapple, potatoes and wheat.

Mexican tolerances ( from 1992 Diuron Residue Chemistry Registration Standard Update) are established for diuron as follows:

7 ppm in/ on asparagus 4 ppm in/ on dry citrus pulp 2 ppm in/ on alfalfa, corn ( forage), sorghum ( forage), wheat ( straw, forage) 1ppm in/ on artichoke, cottonseed, sugarcane, citrus fruit, apple, corn grain, peaches, potatoes, pears, pineapple, sorghum ( grain), wheat ( grain and straw) and grapes. 0.5 ppm in/ on papaya 0.1 ppm in/ on nuts.]


[Federal Register Volume 84, Number 78 (Tuesday, April 23, 2019)]
[Notices]
[Pages 16921-16925]
[FR Doc No: 2019-08099]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-85676; File No. SR-FICC-2019-001]

Self-Regulatory Organizations; Fixed Income Clearing Corporation;
Notice of Filing of Proposed Rule Change To Amend the GSD and MBSD
Methodology Documents and the MBSD Clearing Rules

April 17, 2019.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(``Act'') \1\ and Rule 19b-4 thereunder,\2\ notice is hereby given that
on April 5, 2019, Fixed Income Clearing Corporation (``FICC'') filed
with the Securities and Exchange Commission (``Commission'') the
proposed rule change as described in Items I, II and III below, which
Items have been prepared by the clearing agency. The Commission is
publishing this notice to solicit comments on the proposed rule change
from interested persons.
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    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
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I. Clearing Agency's Statement of the Terms of Substance of the
Proposed Rule Change

    The proposed rule change \3\ consists of amendments to the GSD
Methodology Document--GSD Initial Market Risk Margin Model (``GSD QRM
Methodology Document'') \4\ and the MBSD Methodology and Model
Operations Document--MBSD Quantitative Risk Model \5\ (``MBSD QRM
Methodology Document,'' and together with the GSD QRM Methodology
Document, the ``QRM Methodology Documents'') to remove specific
references (and explanations relating thereto) to the look-back periods
for (1) the alternative volatility calculation (``Margin Proxy'') \6\
of GSD and MBSD and (2) the two haircut rates that form the basis of
the GSD haircut charge.\7\ FICC would replace the specific references
to the look-back periods with more general language that would (i)
refer to a monthly parameter report, (ii) specify the governance around
changing the look-back periods, and (iii) state that the look-back
period would not be less than one year. FICC is also proposing to make
certain clarifications, corrections, and technical changes to the GSD
QRM Methodology Document, and a clarification and certain technical
changes to the MBSD QRM Methodology Document.
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    \3\ Capitalized terms used herein and not defined shall have the
meaning assigned to such terms in the FICC Government Securities
Division (``GSD'') Rulebook (``GSD Rules'') and the FICC Mortgage-
Backed Securities Division (``MBSD,'' and together with GSD, the
``Divisions'') Clearing Rules (``MBSD Rules''), as applicable,
available at http://www.dtcc.com/legal/rules-and-procedures.aspx.
    \4\ The GSD QRM Methodology Document was filed as a confidential
exhibit in the rule filing and advance notice for GSD sensitivity
VaR. See Securities Exchange Act Release No. 83362 (June 1, 2018) 83
FR 26514 (June 7, 2018) (SR-FICC-2018-001) (``GSD Approval Order'')
and Securities Exchange Act Release No. 83223 (May 11, 2018) 83 FR
23020 (May 17, 2018) (SR-FICC-2018-801) (``GSD Advance Notice'').
    \5\ The MBSD QRM Methodology Document was filed as a
confidential exhibit in the rule filing and advance notice for MBSD
sensitivity VaR. See Securities Exchange Act Release No. 79868
(January 24, 2017) 82 FR 8780 (January 30, 2017) (SR-FICC-2016-007)
(``MBSD Approval Order'') and Securities Exchange Act Release No.
79843 (January 19, 2017) 82 FR 8555 (January 26, 2017) (SR-FICC-
2016-801) (``MBSD Advance Notice'').
    \6\ FICC has adopted procedures that would govern in the event
that the vendor fails to provide risk analytics data used by FICC to
calculate the VaR Charge (which is defined in GSD Rule 1 and MBSD
Rule 1). Supra note 3. These procedures include the application of
the Margin Proxy. Specifically, each Division's Margin Proxy would
be applied as an alternative volatility calculation for the VaR
Charge (subject to the VaR Floor) if FICC determines that the data
disruption will extend beyond five (5) business days. See GSD
Approval Order and MBSD Approval Order, supra notes 4 and 5.
    \7\ Occasionally, portfolios contain classes of securities that
reflect market price changes that are not consistently related to
historical risk factors. The value of these securities is often
uncertain because the securities' market volume varies widely, thus
the price histories are limited. Because the volume and price
information for such securities is not robust, a historical
simulation approach would not generate VaR Charge amounts that
adequately reflect the risk profile of such securities. FICC
utilizes a haircut method (hereinafter referred to as the ``GSD
haircut charge'') based on the volatility of historic index returns
for any security that lacks sufficient historical data to be
incorporated into the sensitivity approach. See GSD Approval Order
and MBSD Approval Order, supra notes 4 and 5. The GSD haircut charge
consists of two haircut rates: (i) The haircut rate for mortgage-
backed securities (``MBS'') pools without sensitivity analytics data
and (ii) the haircut rate for Treasury and Agency bonds without
sensitivity analytics data (hereinafter, the ``GSD Haircut Rates'').
The proposal applies to the look-back periods for the GSD Haircut
Rates.
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    FICC is also proposing to make certain clarifications to the MBSD
Rules. Specifically, FICC would add a definition of ``Margin Proxy''
and use

such term in the definition of ``VaR Charge,'' as described below. In
addition, FICC would clarify the definition of ``VaR Charge'' in the
MBSD Rules by adding the word ``Clearing'' before the word ``Members.''
    FICC is requesting confidential treatment of the QRM Methodology
Documents and has filed them separately with the Secretary of the
Commission.\8\
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    \8\ See 17 CFR 240-24b-2.
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II. Clearing Agency's Statement of the Purpose of, and Statutory Basis
for, the Proposed Rule Change

    In its filing with the Commission, the clearing agency included
statements concerning the purpose of and basis for the proposed rule
change and discussed any comments it received on the proposed rule
change. The text of these statements may be examined at the places
specified in Item IV below. The clearing agency has prepared summaries,
set forth in sections A, B, and C below, of the most significant
aspects of such statements.

(A) Clearing Agency's Statement of the Purpose of, and Statutory Basis
for, the Proposed Rule Change

1. Purpose
    The purpose of this rule filing is to amend the QRM Methodology
Documents to remove specific references (and explanations relating
thereto) to the look-back periods for the (1) Margin Proxy of GSD and
MBSD and (2) GSD Haircut Rates. FICC would replace these specific
references to the look-back periods with more general language as
described below. FICC is also proposing to make certain clarifications,
corrections and technical changes to the GSD QRM Methodology Document,
and a clarification and certain technical changes to the MBSD QRM
Methodology Document.
    FICC is also proposing to make certain clarifications to the MBSD
Rules. Specifically, FICC would add a definition of ``Margin Proxy''
and use such term in the definition of ``VaR Charge,'' as described
below. In addition, FICC is proposing to clarify the definition of
``VaR Charge'' in the MBSD Rules by adding the word ``Clearing'' before
the word ``Members.''
(A) Replacing Specific References to the Look-Back Periods for the
Margin Proxy of GSD and MBSD and the GSD Haircut Rates With More
General Language in the QRM Methodology Documents
    Each of the QRM Methodology Documents provides the methodology by
which FICC calculates the GSD and MBSD VaR Charges. The QRM Methodology
Documents specify model inputs, parameters and assumptions, among other
information. With respect to the Margin Proxy, each of the QRM
Methodology Documents refers to the specific look-back periods that are
in use today. Similarly, the GSD QRM Methodology Document refers to the
specific look-back periods for the GSD Haircut Rates. FICC is proposing
to amend the QRM Methodology Documents to remove the specific
references to the current look-back periods in use and replace them
with general language that would refer to a monthly parameter report
(that would contain the specific look-back periods).
    FICC has the discretion to change the look-back periods that are
the subject of this proposal. Specifically, with respect to the GSD
haircut charge, the GSD QRM Methodology Document provides that certain
key model parameters, including the look-back periods for the GSD
Haircut Rates, are subject to periodic review and recalibration.\9\
With respect to the Margin Proxy, the rule filings for GSD sensitivity
VaR and MBSD sensitivity VaR state that if FICC observes material
differences between the Margin Proxy calculations and the aggregate
Clearing Fund requirement calculated using the proposed VaR model
(i.e., the sensitivity approach), or if the Margin Proxy's backtesting
results do not meet FICC's 99 percent confidence level, management may
recommend remedial actions to the Model Risk Governance Committee
(``MRGC''), and to the extent necessary the Management Risk Committee
(``MRC''), such as increasing the look-back period and/or applying an
appropriate historical stressed period to the Margin Proxy
calibration.\10\ By replacing specific references to the look-back
periods in the QRM Methodology Documents with general language, FICC
would be acting within its existing discretion and would no longer need
to submit subsequent rule filings to change these look-back periods
unless such changes require an advance notice.
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    \9\ Supra note 4.
    \10\ See Securities Exchange Act Release No. 82588 (January 26,
2018) 83 FR 4687, 4692 (February 1, 2018) (SR-FICC-2018-001)
(``Notice of GSD Rule Filing''); Securities Exchange Act Release No.
79491 (December 7, 2016) 81 FR 90001, 90005 (December 13, 2016) (SR-
FICC-2016-007) (``Notice of MBSD Rule Filing''); and MBSD Approval
Order, supra note 5, at 8782-8783.
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    Under the proposal, the QRM Methodology Documents would provide
that the look-back periods for the Margin Proxy and the two GSD Haircut
Rates would be tracked in a monthly parameter report. The QRM
Methodology Documents would also provide that these look-back periods
shall not be less than one year. Finally, the QRM Methodology Documents
would state that any changes to these look-back periods would be
subject to the governance process set forth in the Clearing Agency
Model Risk Management Framework (the ``Framework).\11\ The Framework
provides that the Model Validation and Control Group (``MVC'') prepares
Model performance monitoring reports on both a monthly and daily basis.
On a monthly basis, MVC (i) performs sensitivity analysis on each of
FICC's Models,\12\ (ii) reviews key parameters and assumptions for
backtesting, and (iii) considers modifications to ensure that the
backtesting practices of FICC are appropriate for determining the
adequacy of its applicable margin resources.\13\ The Framework states
that MRGC will review the Model performance monitoring, which includes
review of risk-based Models used to calculate margin requirements and
relevant parameters/threshold indicators, sensitivity analysis, and
Model backtesting results. Serious performance concerns will be
escalated to the MRC.\14\
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    \11\ Securities Exchange Act Release No. 81485 (August 25, 2017)
82 FR 41433 (August 31, 2017) (SR-DTC-2017-008; SR-FICC-2017-014;
SR-NSCC-2017-008) (``Framework Approval Order''). In general, the
Framework describes the model risk management practices adopted by
FICC, National Securities Clearing Corporation and The Depository
Trust Company. The Framework is designed to help identify, measure,
monitor, and manage the risks associated with the design,
development, implementation, use, and validation of quantitative
models. The Framework describes (i) governance of the Framework;
(ii) key terms; (iii) model inventory procedures; (iv) model
validation procedures; (v) model approval process; and (vi) model
performance procedures. Id.
    \12\ The term ``Model'' refers to a quantitative method, system,
or approach that applies statistical, economic, financial, or
mathematical theories, techniques, and assumptions to process input
data into quantitative estimates. Id.
    \13\ Id. at 41435.
    \14\ Id.
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(B) Clarifications, Corrections, and Technical Changes to the GSD QRM
Methodology Document, and a Clarification and Technical Changes to the
MBSD QRM Methodology Document
    FICC is proposing to make certain clarifications, corrections, and
technical changes to the GSD QRM Methodology Document, and a
clarification and certain technical changes to the MBSD QRM Methodology
Document, as described in detail below.

(1) GSD QRM Methodology Document
a. Clarifications
    FICC would make certain clarifications to the GSD QRM Methodology
Document, as described below.
    In the section of the GSD QRM Methodology Document that describes
key parameters (where the look-back periods are currently listed), FICC
proposes to rearrange the list so that the look-back periods associated
with sensitivity VaR are grouped together and the look-back periods for
GSD Haircut Rates are grouped together. FICC also proposes to add sub-
headings to enhance readability and clarity.
    In addition, in the section of the GSD QRM Methodology Document
that describes key parameters, FICC would amend the language describing
the GSD Haircut Rates to correspond to the language used in later
sections for clarity and consistency.
    Where the GSD QRM Methodology Document references the governance
practice regarding the review and recalibration of the look-back
periods, FICC also proposes to specifically reference the Framework.
FICC would provide additional clarity by adding language describing
types of data that would be used to determine key model parameters.\15\
FICC would also clarify the GSD QRM Methodology Document by adding
language stating that management may implement any approved changes.
---------------------------------------------------------------------------

    \15\ Supra note 11.
---------------------------------------------------------------------------

    With respect to the descriptions of some of the GSD Haircut Rates,
FICC would (i) add clarifying terminology and (ii) delete duplicative
explanations and replace them with a cross-reference to the appendix,
which contains the same explanation.
b. Corrections
    FICC also proposes to make certain corrections to the GSD QRM
Methodology Document. FICC would correct a typographical error in the
description of key parameters by revising a reference from MBSD to MBS.
In addition, to correct an omission in the GSD QRM Methodology
Document, FICC would add that if FICC observes material differences
between the Margin Proxy calculations and the aggregate Clearing Fund
requirement calculated using the VaR model, management may recommend
remedial actions (as was stated in the GSD sensitivity VaR rule
filing).\16\
---------------------------------------------------------------------------

    \16\ See Notice of GSD Rule Filing, supra note 10, at 4692.
---------------------------------------------------------------------------

c. Technical Changes
    Finally, FICC proposes to make certain technical changes (e.g.,
word usage, spacing corrections, grammar changes, and revising certain
references from singular to plural) to the GSD QRM Methodology
Document. For example, for consistency, FICC proposes to revise a
reference from ``window'' to ``period'' in the description of key
parameters and all references from ``lookback'' to ``look-back'' and
from ``TBA/pool'' to ``Pool-TBA.''
(2) MBSD QRM Methodology Document
a. Clarification
    FICC proposes to clarify the MBSD Methodology Document by adding
language stating that management may implement any approved changes.
b. Technical Changes
    FICC proposes to make certain technical changes to the MBSD QRM
Methodology Document (e.g., grammar changes and revising certain
references from singular to plural). FICC would also revise a reference
from ``lookback'' to ``look-back'' for consistency. In addition, FICC
would remove the revision history because it is solely administrative
and would not affect the calculation of margin or Clearing Members'
substantive rights or obligations.
(C) Clarifications to the MBSD Rules
    FICC is also proposing to make certain clarifications to the MBSD
Rules. Specifically, FICC would add a definition of ``Margin Proxy''
and use such term in the definition of ``VaR Charge.'' In addition,
FICC would clarify the definition of ``VaR Charge'' in the MBSD Rules
by adding the word ``Clearing'' before the word ``Members.''
2. Statutory Basis
    FICC believes that this proposal is consistent with the
requirements of the Act and the rules and regulations thereunder
applicable to a registered clearing agency. Specifically, FICC believes
that the proposed changes to the QRM Methodology Documents and the MBSD
Rules described above are consistent with Section 17A(b)(3)(F) of the
Act, for the reasons described below.\17\ FICC also believes that the
proposed changes to the MBSD Rules are consistent with Rule 17Ad-
22(e)(23)(ii), as promulgated under the Act, for the reasons described
below.\18\
---------------------------------------------------------------------------

    \17\ 15 U.S.C. 78q-1(b)(3)(F).
    \18\ 17 CFR 240.17Ad-22(e)(23)(ii).
---------------------------------------------------------------------------

    Section 17A(b)(3)(F) of the Act requires, in part, that the rules
of a clearing agency be designed ``to assure the safeguarding of
securities and funds which are in the custody or control of the
clearing agency or for which it is responsible.'' \19\
---------------------------------------------------------------------------

    \19\ 15 U.S.C. 78q-1(b)(3)(F).
---------------------------------------------------------------------------

    FICC believes that amending the QRM Methodology Documents to remove
specific references (and explanations relating thereto) to the look-
back periods for the (1) Margin Proxy of GSD and MBSD and (2) the GSD
Haircut Rates and replace them with more general language as described
above would enhance clarity and consistency for FICC. Specifically, the
proposed changes would ensure that the QRM Methodology Documents (which
have been filed confidentially) are in line with the understanding of
FICC's risk management group (``FICC Risk Management'') that, if FICC
observes material differences between the Margin Proxy calculations and
the aggregate Clearing Fund requirement calculated using the VaR model,
or if the Margin Proxy's backtesting results do not meet FICC's 99
percent confidence level, then, subject to its MRGC/MRC governance
process described above, FICC may change the look-back periods for the
GSD and MBSD Margin Proxy as long as the look-back periods are not less
than one year. Similarly, if FICC observes that the asset class
backtesting performance associated with the GSD Haircut Rates is not at
the 99% confidence level, then, subject to its MRGC/MRC governance
process described above, FICC may change the look-back periods for the
GSD Haircut Rates as long as the look-back periods are not less than
one year. FICC believes that enhancing clarity and consistency within
FICC with respect to changes to the aforementioned look-back periods
would help to ensure that FICC calculates and collects adequate margin
from its Clearing Members and Netting Members and would thereby assure
the safeguarding of securities and funds which are in the custody or
control of FICC or for which it is responsible, consistent with Section
17A(b)(3)(F) the Act.\20\
---------------------------------------------------------------------------

    \20\ Id.
---------------------------------------------------------------------------

    FICC believes that the proposed changes, which constitute certain
clarifications, corrections, and technical changes to the GSD QRM
Methodology Document, and a clarification and certain technical changes
to the MBSD QRM Methodology Document, would also enhance the clarity of
the QRM Methodology Documents for FICC. As the QRM Methodology
Documents are used by FICC Risk Management personnel regarding the
calculation of

margin requirements, it is important for the accurate and smooth
functioning of the margining process that FICC Risk Management
understands when look-back periods can change and the governance
process associated with them. The changes referenced in this paragraph
would promote such understanding. This would, in turn, allow FICC Risk
Management to charge an appropriate level of margin. As such, FICC
believes that enhancing the clarity of the QRM Methodology Documents
would assure the safeguarding of securities and funds which are in the
custody or control of FICC or for which it is responsible, consistent
with Section 17A(b)(3)(F) the Act.\21\
---------------------------------------------------------------------------

    \21\ Id.
---------------------------------------------------------------------------

    FICC believes the proposed clarifications to Rule 1 of the MBSD
Rules would help ensure that the calculation of margin is clear and
transparent to Clearing Members and FICC, and thereby, help ensure that
FICC calculates and collects adequate margin from Clearing Members and
that Clearing Members understand the relevant definition. As such, FICC
believes that the proposed clarifications to Rule 1 of the MBSD Rules
would also assure the safeguarding of securities and funds which are in
the custody and control of FICC or for which it is responsible,
consistent with Section 17A(b)(3)(F) the Act.\22\
---------------------------------------------------------------------------

    \22\ Id.
---------------------------------------------------------------------------

    Rule 17Ad-22(e)(23)(ii) under the Act requires FICC to establish,
implement, maintain and enforce written policies and procedures
reasonably designed to provide sufficient information to enable
participants to identify and evaluate the risks, fees, and other
material costs they incur by participating in the covered clearing
agency.\23\ FICC believes the proposed clarifications to Rule 1 of the
MBSD Rules would help ensure that the calculation of margin is
transparent and clear to Clearing Members, thereby enabling Clearing
Members to better understand the calculation of margin as well as
providing them with increased predictability and certainty regarding
their obligations. As such, FICC believes that the proposed rule
changes are consistent with Rule 17Ad-22(e)(23)(ii) under the Act.\24\
---------------------------------------------------------------------------

    \23\ 17 CFR 240.17Ad-22(e)(23)(ii).
    \24\ Id.
---------------------------------------------------------------------------

(B) Clearing Agency's Statement on Burden on Competition

    FICC believes that the proposed changes to amend the QRM
Methodology Documents to remove specific references (and explanations
relating thereto) to the look-back periods for the (1) Margin Proxy of
GSD and MBSD and (2) GSD Haircut Rates and replace them with more
general language (as described above) could have an impact on
competition. Specifically, FICC believes that the proposed change could
burden competition because changes to the look-back periods could
result in larger Required Fund Deposits amounts for some Members than
the amount currently calculated.
    When the proposal results in a larger Required Fund Deposit for
Members, the proposed changes could burden competition for Members that
have lower operating margins or higher costs of capital compared to
other Members. Whether such burden on competition would be significant
would depend on each Member's financial status and the specific risks
presented by each Member's portfolio. Regardless of whether the burden
on competition would be significant, FICC believes that any burden on
competition imposed by the proposed changes would be both necessary and
appropriate in furtherance of FICC's efforts to mitigate risks and meet
the requirements of the Act,\25\ as described in this filing and
further below.
---------------------------------------------------------------------------

    \25\ 15 U.S.C. 78q-1(b)(3)(I).
---------------------------------------------------------------------------

    FICC believes the above-described burden on competition that may be
created by the proposed changes to amend the QRM Methodology Documents
to remove specific references (and explanations relating thereto) to
the look-back periods for the (1) Margin Proxy of GSD and MBSD and (2)
GSD Haircut Rates and replace them with more general language would be
necessary in furtherance of the Act.\26\ As stated above, with respect
to the Margin Proxy, the proposed change would address situations where
FICC observes material differences between the Margin Proxy
calculations and the aggregate Clearing Fund requirement calculated
using the VaR model, or where the Margin Proxy's backtesting results do
not meet FICC's 99 percent confidence level. Similarly, with respect to
the GSD Haircut Rates, the proposed changes would address situations
where FICC observes that asset class backtesting performance is not at
the 99% confidence level. Specifically, the proposed changes would help
ensure that the QRM Methodology Documents (which have been filed
confidentially) are in line with FICC Risk Management's understanding
that, in those circumstances, FICC may change the look-back periods for
the GSD and MBSD Margin Proxy and GSD Haircut Rates as long as the
look-back periods are not less than one year. FICC believes that
enhancing clarity and consistency within FICC with respect to changes
to the aforementioned look-back periods would help to ensure that FICC
calculates and collects adequate margin from its Clearing Members and
Netting Members and would thereby assure the safeguarding of securities
and funds which are in the custody or control of FICC or for which it
is responsible, consistent with Section 17A(b)(3)(F) the Act.\27\
---------------------------------------------------------------------------

    \26\ Id.
    \27\ 15 U.S.C. 78q-1(b)(3)(F).
---------------------------------------------------------------------------

    FICC also believes that the above-described burden on competition
that could be created by the proposed change to amend the QRM
Methodology Documents to remove specific references (and explanations
relating thereto) to the look-back periods for the (1) Margin Proxy of
GSD and MBSD and (2) GSD Haircut Rates and replace them with more
general language would be appropriate in furtherance of the Act.\28\
FICC believes these proposed changes would be appropriate in
furtherance of the Act because they have been designed to assure the
safeguarding of securities and funds which are in the custody or
control of FICC or for which it is responsible. The proposal achieves
this purpose by providing for FICC to act in circumstances where the
99% confidence level is not being met. Specifically, FICC would only
change the look-back periods in certain circumstances (i.e., where FICC
observes material differences between the Margin Proxy calculations and
the aggregate Clearing Fund requirement calculated using the
sensitivity VaR model, or where the Margin Proxy's backtesting results
do not meet FICC's 99 percent confidence level), and/or where FICC
observes that the asset class backtesting performance is not at the 99%
confidence level. Furthermore, FICC believes these proposed changes are
appropriate because they would be consistent with the discretion
(subject to FICC's governance) that FICC has to make changes to the
look-back periods consistent with the GSD and MBSD sensitivity VaR
filings and GSD QRM Methodology Document.\29\ As such, FICC believes
these proposed changes would help to ensure that FICC calculates and
collects adequate margin from its Clearing Members and Netting Members,
and therefore, are designed to assure the safeguarding of securities
and funds, consistent with Section 17A(b)(3)(F) the Act.\30\
---------------------------------------------------------------------------

    \28\ 15 U.S.C. 78q-1(b)(3)(I).
    \29\ Supra notes 4, 5, and 10.
    \30\ 15 U.S.C. 78q-1(b)(3)(F).

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

    In addition, FICC does not believe the proposed clarifications,
corrections, and technical changes to the GSD QRM Methodology Document
and the proposed clarification and technical changes to the MBSD QRM
Methodology Document described above would have any impact on
competition because these proposed changes would enhance the clarity
and accuracy of the QRM Methodology Documents and would not affect the
substantive rights of Netting Members and Clearing Members.
    FICC also does not believe that the proposed clarifications to the
MBSD Rules would have any impact on competition because these proposed
changes would enhance the clarity and accuracy of the MBSD Rules and
would not affect the substantive rights of Clearing Members.

(C) Clearing Agency's Statement on Comments on the Proposed Rule Change
Received From Members, Participants, or Others

    FICC has not received or solicited any written comments relating to
this proposal. FICC will notify the Commission of any written comments
received by FICC.

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

    Within 45 days of the date of publication of this notice in the
Federal Register or within such longer period up to 90 days (i) as the
Commission may designate if it finds such longer period to be
appropriate and publishes its reasons for so finding or (ii) as to
which the self-regulatory organization consents, the Commission will:
    (A) By order approve or disapprove such proposed rule change, or
    (B) institute proceedings to determine whether the proposed rule
change should be disapproved.

IV. Solicitation of Comments

    Interested persons are invited to submit written data, views and
arguments concerning the foregoing, including whether the proposed rule
change is consistent with the Act. Comments may be submitted by any of
the following methods:

Electronic Comments

     Use the Commission's internet comment form (http://www.sec.gov/rules/sro.shtml); or
     Send an email to [email protected]. Please include
File Number SR-FICC-2019-001 on the subject line.

Paper Comments

     Send paper comments in triplicate to Secretary, Securities
and Exchange Commission, 100 F Street NE, Washington, DC 20549.

All submissions should refer to File Number SR-FICC-2019-001. This file
number should be included on the subject line if email is used. To help
the Commission process and review your comments more efficiently,
please use only one method. The Commission will post all comments on
the Commission's internet website (http://www.sec.gov/rules/sro.shtml).
Copies of the submission, all subsequent amendments, all written
statements with respect to the proposed rule change that are filed with
the Commission, and all written communications relating to the proposed
rule change between the Commission and any person, other than those
that may be withheld from the public in accordance with the provisions
of 5 U.S.C. 552, will be available for website viewing and printing in
the Commission's Public Reference Room, 100 F Street NE, Washington, DC
20549 on official business days between the hours of 10:00 a.m. and
3:00 p.m. Copies of the filing also will be available for inspection
and copying at the principal office of FICC and on DTCC's website
(http://dtcc.com/legal/sec-rule-filings.aspx). All comments received
will be posted without change. Persons submitting comments are
cautioned that we do not redact or edit personal identifying
information from comment submissions. You should submit only
information that you wish to make available publicly. All submissions
should refer to File Number SR-FICC-2019-001 and should be submitted on
or before May 14, 2019.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\31\
---------------------------------------------------------------------------

    \31\ 17 CFR 200.30-3(a)(12).
---------------------------------------------------------------------------

Jill M. Peterson,
Assistant Secretary.
[FR Doc. 2019-08099 Filed 4-22-19; 8:45 am]
 BILLING CODE 8011-01-P


[Federal Register Volume 87, Number 23 (Thursday, February 3, 2022)]
[Notices]
[Pages 6169-6170]
[FR Doc No: 2022-02197]

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

ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPP-2017-0750; FRL-9451-01-OCSPP]

Pesticide Registration Review; Proposed Interim Decisions for
Several Pesticides; Notice of Availability

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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

SUMMARY: 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:
Dimethoxane; ferbam; iprodione; laminarin; linalool; thiram; and ziram.

DATES: Comments must be received on or before April 4, 2022.

ADDRESSES: Submit your comments, identified by the docket
identification (ID) number for the specific pesticide of interest
provided in the Table in Unit IV., using the Federal eRulemaking Portal
at http://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. Additional
instructions on commenting or visiting the docket, along with more
information about dockets generally, is available at http://www.epa.gov/dockets.
    Due to the public health concerns related to COVID-19, the EPA/DC
and Reading Room is closed to visitors with limited exceptions. The
staff continues to provide remote customer service via email, phone,
and webform. For the latest status information on the EPA/DC and docket
access, 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; email address:
[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. 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 1 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: https://www.epa.gov/dockets/commenting-epa-dockets.
    3. Environmental justice. EPA seeks to achieve environmental
justice, the fair treatment and meaningful involvement of any group,
including minority and/or low-income populations, in the development,
implementation, and enforcement of environmental laws, regulations, and
policies. To help address potential environmental justice issues, the
Agency seeks information on any groups or segments of the population
who, as a result of their location, cultural practices, or other
factors, may have atypical or disproportionately high and adverse human
health impacts or environmental effects from exposure to the pesticides
discussed in this document, compared to the general population.

II. Background

    Registration review is EPA's periodic review of pesticide
registrations to ensure that each pesticide continues to satisfy the
statutory standard for registration, that is, the pesticide can perform
its intended function without unreasonable adverse effects on human
health or the environment. As part of the registration review process,
the Agency has completed proposed interim decisions for all pesticides
listed in the Table 1 in Unit IV. Through this program, EPA is ensuring
that each pesticide's registration is based on current scientific and
other knowledge, including its effects on human health and the
environment.

III. Authority

    EPA is conducting its registration review of the chemicals listed
in the Table 1 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.

IV. What action is the agency taking?

    Pursuant to 40 CFR 155.58, this notice announces the availability
of EPA's proposed interim registration review decisions for the
pesticides shown in Table 1 and opens a 60-day public comment period on
the proposed interim registration review decisions.

                                       Table 1--Proposed Interim Decisions
----------------------------------------------------------------------------------------------------------------
                                                                                Chemical review manager
 Registration review case name and No.                   Docket ID No.                  and contact information
----------------------------------------------------------------------------------------------------------------
Dimethoxane, Case Number 3064..........  EPA-HQ-OPP-2010-0686                          Kimberly Wilson,
                                                                                [email protected],
<PHONE_NUMBER>.
Ferbam, Case Number 8000...............  EPA-HQ-OPP-2015-0567                          Marisa Wright,
                                                                                [email protected],
<PHONE_NUMBER>.
Iprodione, Case Number 2335............  EPA-HQ-OPP-2012-0392                          Rachel Fletcher,
                                                                                [email protected],
<PHONE_NUMBER>
Laminarin, Case Number 6309............  EPA-HQ-OPP-2021-0445                          Jennifer Odom,
                                                                                [email protected],
<PHONE_NUMBER>
Linalool, Case Number 6058.............  EPA-HQ-OPP-2021-0423                          Hannah Dean,
                                                                                [email protected],
<PHONE_NUMBER>
Thiram, Case Number 0122...............  EPA-HQ-OPP-2015-0433                          Marisa Wright,
                                                                                [email protected],
<PHONE_NUMBER>
Ziram, Case Number 8001................  EPA-HQ-OPP-2015-0568                          Marisa Wright,
                                                                                [email protected],
<PHONE_NUMBER>
----------------------------------------------------------------------------------------------------------------

    The registration review docket for a pesticide includes earlier
documents related to the registration review case. For example, the
review opened with a Preliminary Work Plan, for public comment. A Final
Work Plan was placed in the docket following public comment on the
Preliminary Work Plan.
    The documents in the dockets describe EPA's rationales for
conducting additional risk assessments for the registration review of
the pesticides included in the tables in Unit IV, as well as the
Agency's subsequent risk findings and consideration of possible risk
mitigation measures. These proposed interim registration review
decisions are supported by the rationales included in those documents.
Following public comment, the Agency will issue interim or final
registration review decisions for the pesticides listed in Table 1 in
Unit IV.
    The registration review final rule at 40 CFR 155.58(a) provides for
a minimum 60-day public comment period on all proposed interim
registration review decisions. This comment period is intended to
provide an opportunity for public input and a mechanism for initiating
any necessary amendments to the proposed interim decision. All comments
should be submitted using the methods in ADDRESSES and must be received
by EPA on or before the closing date. These comments will become part
of the docket for the pesticides included in the Tables in Unit IV.
Comments received after the close of the comment period will be marked
``late.'' EPA is not required to consider these late comments.
    The Agency will carefully consider all comments received by the
closing date and may provide a ``Response to Comments Memorandum'' in
the docket. The interim registration review decision will explain the
effect that any comments had on the interim decision and provide the
Agency's response to significant comments.
    Background on the registration review program is provided at:
https://www.epa.gov/pesticide-reevaluation.
    Authority: 7 U.S.C. 136 et seq.

    Dated: January 27, 2022.
Mary Elissa Reaves,
Director, Pesticide Re-Evaluation Division, Office of Pesticide
Programs.
[FR Doc. 2022-02197 Filed 2-2-22; 8:45 am]
BILLING CODE 6560-50-P