[Federal Register Volume 84, Number 192 (Thursday, October 3, 2019)]
[Rules and Regulations]
[Pages 52775-52778]
[FR Doc No: 2019-20528]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2017; FRL-9994-70]

Nicotinamide; Exemption From the Requirement of a Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes an exemption from the requirement
of a tolerance for residues of nicotinamide (CAS Reg. No. 98-92-0) when
used as an inert ingredient (corrosion inhibitor) on growing crops only
and limited to 5.0% in a pesticide formulation. Dow AgroSciences LLC
submitted a petition to EPA under the Federal Food, Drug, and Cosmetic
Act (FFDCA), requesting an amendment to an existing requirement of a
tolerance. This regulation eliminates the need to establish a maximum
permissible level for residues of nicotinamide.

DATES: This regulation is effective October 3, 2019. Objections and
requests for hearings must be received on or before December 2, 2019
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-2017-0046, is available at http://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 is<PHONE_NUMBER>, and the telephone number for the OPP
Docket is<PHONE_NUMBER>. Please review the visitor instructions and
additional information about the docket available at http://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: Michael L. Goodis, Registration
Division (7505P), Office of Pesticide Programs, Environmental
Protection Agency, 1200 Pennsylvania Ave. NW, Washington, DC 20460-
0001; main telephone number:<PHONE_NUMBER>; email address:
<EMAIL_ADDRESS>
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 40 CFR
part 180 through the Government Publishing Office's e-CFR site at
http://www.ecfr.gov/cgi-bin/text-idx?&c=ecfr&tpl=/ecfrbrowse/Title40/40tab_02.tpl.

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-2017-0046 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
December 2, 2019. 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-2017-0046, by one of
the following methods:
     Federal eRulemaking Portal: http://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 http://www.epa.gov/dockets/contacts.html. Additional
instructions on commenting or visiting the docket, along with more
information about dockets generally, is available at http://www.epa.gov/dockets.

II. Petition for Exemption

    In the Federal Register of June 8, 2017 (82 FR 26641) (FRL-9961-
14), EPA issued a document pursuant to FFDCA section 408, 21 U.S.C.
346a, announcing the filing of a pesticide petition (IN-11012) by Dow
AgroSciences LLC, 9330 Zionsville Road, Indianapolis, IN 46268. The
petition requested that 40 CFR 180.920 be amended by establishing an
exemption from the requirement of a tolerance for residues of
nicotinamide (CAS Reg. No. 98-92-0) when used as an inert ingredient
(corrosion inhibitor) in pesticide formulations applied to growing
crops, limited to 5% in the pesticide formulation. That document
referenced a summary of the petition prepared by Dow AgroSciences LLC,
the petitioner, which is available in the docket, http://www.regulations.gov. Comments were received on the notice of filing.
EPA's response to these comments is discussed in Unit V.B.

III. Inert Ingredient Definition

    Inert ingredients are all ingredients that are not active
ingredients as defined in 40 CFR 153.125 and include, but are not
limited to, the following types of ingredients (except when they have a
pesticidal efficacy of their own): Solvents such as alcohols and
hydrocarbons; surfactants such as polyoxyethylene polymers and fatty
acids; carriers such as clay; thickeners such as carrageenan and
modified cellulose; wetting, spreading, and dispersing agents;
propellants in aerosol dispensers; microencapsulating agents; and
emulsifiers. The term ``inert'' is not intended to imply nontoxicity;
the ingredient may or may not be chemically active. Generally, EPA has
exempted inert ingredients from the requirement of a tolerance based on
the low toxicity of the individual inert ingredients.

IV. Aggregate Risk Assessment and Determination of Safety

    Section 408(c)(2)(A)(i) of FFDCA allows EPA to establish an
exemption from the requirement for 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(c)(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(c)(2)(B) requires EPA to take into
account the considerations set forth in subparagraphs (C) and (D) of
subsection (b)(2) when making this exemption safety determination.
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. . .
.''
    EPA establishes exemptions from the requirement of a tolerance only
in those cases where it can be clearly demonstrated that the risks from
aggregate exposure to pesticide chemical residues under reasonably
foreseeable circumstances will pose no appreciable risks to human
health. In order to determine the risks from aggregate exposure to
pesticide inert ingredients, the Agency considers the toxicity of the
inert in conjunction with possible exposure to residues of the inert
ingredient through food, drinking water, and through other exposures
that occur as a result of pesticide use in residential settings. If EPA
is able to determine that a finite tolerance is not necessary to ensure
that there is a reasonable certainty that no harm will result from
aggregate exposure to the inert ingredient, an exemption from the
requirement of a tolerance may be established.
    Consistent with FFDCA section 408(c)(2)(A), and the factors
specified in FFDCA section 408(c)(2)(B), 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 nicotinamide including exposure
resulting from the exemption established by this action. EPA's
assessment of exposures and risks associated with nicotinamide follows.

A. Toxicological Profile

    EPA has evaluated the available toxicity data and considered their
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. Specific information on the studies received and the nature
of the adverse effects caused by nicotinamide as well as the no-
observed-adverse-effect-level (NOAEL) and the lowest-observed-adverse-
effect-level (LOAEL) from the toxicity studies are discussed in this
unit.
    Nicotinamide is a water-soluble B-complex vitamin which is present
naturally in animal products, whole cereals and legumes. Together with
nicotinic acid (niacin), nicotinamide belongs to vitamin B3 and is
required as a nutrient to prevent niacin deficiency disorders such as
pellagra. It functions as a coenzyme or co-substrate in many biological
reduction and oxidation reactions required for energy metabolism in
mammalian systems. It is used as a nutritional supplement, therapeutic
agent, skin and hair conditioning agent in cosmetics and a constituent
of consumer, household solvent and cleaning products.
    As a nutritional supplement and vitamin, recommended daily dietary
allowances and maximum daily doses have been established by the
Institute of Medicine (US) Standing Committee on the Scientific
Evaluation of Dietary Reference Intakes and its Panel on Folate, Other
B Vitamins, and Choline. The committee also established the tolerance
upper intake level at 35 mg/day based on flushing as a critical adverse
effect. The level applies to all forms of niacin added to foods or
taken as supplements, including nicotinamide. Although nicotinamide is
not associated with flushing effects, a UL for nicotinic acid based on
flushing is protective against the other effects seen in the available
toxicity studies.
    Nicotinamide exhibits low levels of acute toxicity. The rat acute
oral lethal dose (LD50) is 3,000-7,000 milligrams/kilogram
(mg/kg). The acute dermal LD50 for rabbits is > 2,000 mg/kg.
Nicotinamide is negative for skin sensitization in the guinea pig. It
is not irritating to rabbit skin. Nicotinamide is considered irritating
to rabbit eyes.
    In a 4-week oral toxicity via gavage, no adverse effects were
observed in female rats at dose levels below treated with 1,000 mg/kg/
day of nicotinamide.
    In a developmental toxicity study involving exposure to nicotinic
acid, no effects in the dams (decreased body weight gains and
significantly decreased placental weights) and fetuses (significantly
lower body weights in male offspring) were observed at dose levels
below 1,000 mg/kg/day. The NOAEL for maternal and developmental
toxicity is 200 mg/kg/day (198 mg/kg/day for nicotinamide). This study
is deemed relevant to the assessment of nicotinamide since nicotinamide
converts to nicotinic acid in the gut.
    Nicotinamide was negative in Ames tests, micronucleus tests, with
and without metabolic activation. No chromosomal effects were reported
in mammalian cells. Positive results were seen in a sister chromatid
exchange induction study. However, it was noted that activity was only
seen at excessively high concentrations. Based on the weight of
evidence, nicotinamide is considered negative for mutagenicity.
    Nicotinamide is not carcinogenic. No increased incidence of tumors
was observed in a lifetime carcinogenicity study with Swiss mice
receiving 1.0% (equivalent to 66.3 and 100 mg/kg/day in female and male
rats, respectively) nicotinamide in the diet.
    There were no data directly regarding the potential for
neurotoxicity or immunotoxicity of nicotinamide. However, there is no
evidence of potential neurotoxicity or immunotoxicity in the available
data.
    Metabolism of nicotinamide in humans is well understood.
Nicotinamide is necessary for lipid metabolism, tissue respiration and
glycogenolysis. It is readily absorbed in the gastrointestinal (g.i.)
tract. In vivo, nicotinamide is formed from the conversion of nicotinic
acid (niacin), while some dietary nicotinamide is oxidized to nicotinic
acid and then to nicotinamide. Nicotinamide is incorporated into two
coenzymes: Nicotinamide adenine dinucleotide (NAD) and nicotinamide
adenine dinucleotide phosphate (NADP) which act as hydrogen-carrier
molecules in glycogenolysis, tissue respiration and lipid metabolism.
It can be incorporated into NADP either directly or after deamidation,
or metabolized in the liver and excreted in the urine. The primary
metabolites are N-methylniacinamide and N-methyl-2-pyridone-5-
carboxamide, though it may also be excreted unchanged.

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 the NOAEL and the LOAEL are identified.
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 http://www.epa.gov/pesticides/factsheets/riskassess.htm.
    The available toxicity studies indicate that nicotinamide has a
very low overall toxicity. No effects are observed below 1,000 mg/kg/
day, the limit dose. Since signs of toxicity were not observed below
the limit dose an endpoint of concern for risk assessment purposes was
not identified.

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary
exposure to nicotinamide, EPA considered exposure expected under the
proposed exemption from the requirement of a tolerance as well as from
the existing approved uses. EPA assessed dietary exposures from
nicotinamide in food as follows:
    Nicotinamide is already approved for use (synergist) on growing
crops. The current request (for use as a corrosion inhibitor) increases
dietary exposure (food and drinking water) to nicotinamide that can
occur following ingestion of foods with residues from treated crops. In
addition, dietary exposure to nicotinamide may also occur through foods
that contain it naturally, such as grains, meat and milk; fortified
foods, and dietary supplements. However, a quantitative dietary
exposure assessment was not conducted since a toxicological endpoint
for risk assessment was not identified.
    2. Dietary exposure from drinking water. Since a hazard endpoint of
concern was not identified for the acute and chronic dietary
assessment, a quantitative dietary exposure risk assessment for
drinking water was not conducted, although exposures may be expected
from use on food crops.
    3. From non-dietary exposure. The term ``residential exposure'' is
used in this document to refer to non-occupational, non-dietary
exposure (e.g., textiles (clothing and diapers), carpets, swimming
pools, and hard surface disinfection on walls, floors, tables).
    Nicotinamide may be used as an inert ingredient in pesticide
products that are registered for specific uses that may result in
residential exposure, such as pesticides used in and around the home,
and in non-pesticide products such as household products, personal care
products and cosmetics. However, based on the lack of a hazard endpoint
of concern, a quantitative residential exposure assessment for
nicotinamide was not conducted.
    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.''
    EPA has not found nicotinamide to share a common mechanism of
toxicity with any other substances, and nicotinamide does not appear to
produce a toxic metabolite produced by other substances. For the
purposes of this tolerance action, therefore, EPA has assumed that
nicotinamide does not have a common mechanism of toxicity with other
substances. For information regarding EPA's efforts to determine which
chemicals have a common mechanism of toxicity and to evaluate the
cumulative effects of such chemicals, see EPA's website at http://www.epa.gov/pesticides/cumulative.

D. Safety Factor for Infants and Children

    Based on the lack of threshold effects, EPA has not identified any
toxicological endpoints of concern and is conducting a qualitative
assessment of nicotinamide. The qualitative assessment does not use
safety factors for assessing risk, and no additional safety factor is
needed for assessing risk to infants and children. Based on an
assessment of nicotinamide, EPA has concluded that there are no
toxicological endpoints of concern for the U.S. population, including
infants and children.

E. Aggregate Risks and Determination of Safety

    Because no toxicological endpoints of concern were identified, EPA
concludes that aggregate exposure to residues of nicotinamide will not
pose a risk to the U.S. population, including infants and children, and
that there is a reasonable certainty that no harm will result to the
general population, or to infants and children from aggregate exposure
to nicotinamide residues.

V. Other Considerations

A. Analytical Enforcement Methodology

    An analytical method is not required for enforcement purposes since
the Agency is establishing an exemption from the requirement of a
tolerance without any numerical limitation.

B. Response to Comments

    Two comments were received concerning the safety and impact of
pesticides on food and human health. Although the Agency recognizes
that some individuals believe that no residue of pesticides should be
allowed in or on food, the existing legal framework provided by section
408 of the FFDCA authorizes the establishment of pesticide tolerances
or exemptions where the Agency determines that tolerance or exemption
meets the safety standard imposed by the statute. EPA has sufficient
data to support a safety determination for the exemption from the
requirement of a tolerance for nicotinamide. The commenters have
provided no additional information supporting a determination that the
exemption is not safe.

VI. Conclusions

    Therefore, an exemption from the requirement of a tolerance is
established under 40 CFR 180.920 for nicotinamide (CAS Reg. No. 98-92-
0) when used as an inert ingredient (corrosion inhibitor) in pesticide
formulations applied to growing crops, limited to 5.0% in a pesticide
formulation.

VII. Statutory and Executive Order Reviews

    This action establishes a tolerance exemption 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); Executive
Order 13045, entitled ``Protection of Children from Environmental
Health Risks and Safety Risks'' (62 FR 19885, April 23, 1997); or
Executive Order 13771, entitled ``Reducing Regulations and Controlling
Regulatory Costs'' (82 FR 9339, February 3, 2017). 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 exemption 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).

VIII. 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: September 11, 2019.
Michael Goodis,
Director, Registration Division, Office of Pesticide Programs.

    Therefore, 40 CFR chapter I is amended as follows:

PART 180--[AMENDED]

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. In Sec.  180.920, revise the inert ingredient ``Nicotinamide (CAS
Reg. No. 98-92-0)'' in the table to read as follows:

Sec.  180.920  Inert ingredients used pre-harvest; exemptions from the
requirement of a tolerance.

* * * * *

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         Inert ingredients                                Limits                                 Uses
----------------------------------------------------------------------------------------------------------------

                                                  * * * * * * *
Nicotinamide (CAS Reg. No. 98-92-0)  Not to exceed 0.5% by weight of pesticide        Synergist, Corrosion
                                      formulation as synergist; not to exceed 5% by    Inhibitor
                                      weight of pesticide formulation as corrosion
                                      inhibitor.

                                                  * * * * * * *
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[FR Doc. 2019-20528 Filed 10-2-19; 8:45 am]
 BILLING CODE 6560-50-P


[Federal Register Volume 83, Number 98 (Monday, May 21, 2018)]
[Notices]
[Pages 23513-23515]
[FR Doc No: 2018-10712]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-83247; File No. SR-CboeBZX-2018-035]

Self-Regulatory Organizations; Cboe BZX Exchange, Inc.; Notice of
Filing and Immediate Effectiveness of a Proposed Rule Change To Amend
Rule 2.12 To Add References to Cboe Options and C2

May 15, 2018.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(the ``Act''),\1\ and Rule 19b-4 thereunder,\2\ notice is hereby given
that on May 14, 2018, Cboe BZX Exchange, Inc. (``BZX'' or the
``Exchange'') filed with the Securities and Exchange Commission
(``Commission'') the proposed rule change as described in Items I and
II below, which Items have been prepared by the Exchange. The Exchange
has designated this proposal as a ``non-controversial'' proposed rule
change pursuant to Section 19(b)(3)(A) of the Act \3\ and Rule 19b-
4(f)(6)(iii) thereunder,\4\ which renders it effective upon filing with
the Commission. 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.
    \3\ 15 U.S.C. 78s(b)(3)(A).
    \4\ 17 CFR 240.19b-4(f)(6)(iii).
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I. Self-Regulatory Organization's Statement of the Terms of Substance
of the Proposed Rule Change

    The Exchange filed a proposal to amend Rule 2.12 to add references
to Cboe Exchange, Inc. (``Cboe Options'') and Cboe C2 Exchange, Inc.
(``C2''). The Exchange does not propose to amend the requirements of
this rule.
(additions are italicized; deletions are [bracketed])
* * * * *

Cboe BZX Exchange, Inc.

Rules

* * * * *

Rule 2.12. Cboe Trading, Inc. as Inbound Router

    (a) For so long as the Exchange is affiliated with Cboe Exchange,
Inc., Cboe C2 Exchange, Inc., Cboe BYX Exchange, Inc., Cboe EDGA
Exchange, Inc. or Cboe EDGX Exchange Inc., (each, a ``Cboe [Bats
]Exchange''), and Cboe Trading, Inc. in its capacity as a facility of
each Cboe [Bats ]Exchange is utilized for the routing of orders from
each Cboe [Bats ]Exchange to the Exchange, (such function of Cboe
Trading, Inc. is referred to as the ``Inbound Router''), the Exchange
undertakes as follows:
    (1)-(4) No change.
    (b) Provided the above conditions are complied with, and provided
further that Cboe Trading, Inc. operates as an outbound router on
behalf of each Cboe [Bats ]Exchange on the same terms and conditions as
it does for the Exchange, and in accordance with the Rules of each Cboe
[Bats ]Exchange, Cboe Trading, Inc. may provide inbound routing
services to the Exchange from each Cboe [Bats ]Exchange.
* * * * *
    The text of the proposed rule change is available at the Exchange's
website at www.markets.cboe.com, at the principal office of the
Exchange, and at the Commission's Public Reference Room.

II. Self-Regulatory Organization's Statement of the Purpose of, and
Statutory Basis for, the Proposed Rule Change

    In its filing with the Commission, the Exchange 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 Exchange has prepared summaries, set forth in
Sections A, B, and C below, of the most significant parts of such
statements.

A. Self-Regulatory Organization's Statement of the Purpose of, and
Statutory Basis for, the Proposed Rule Change

1. Purpose
    In December 2016, the Exchange and its affiliates \5\ received
approval to effect a merger (the ``Merger'') of the Exchange's parent
company, Bats Global Markets, Inc. with CBOE Holdings, Inc. (now known
as Cboe Global Markets, Inc.), the parent company of Cboe Options and
C2.\6\ Hereinafter, the Exchange, BYX, EDGA, EDGX, Cboe Options, and C2
will be collectively referred to as the ``Cboe Affiliated Exchanges.''
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    \5\ As of December 2016, the Exchange's affiliates included Cboe
BYX Exchange, Inc. (formerly Bats BYX Exchange. Inc.) (``BYX''),
Cboe EDGA Exchange, Inc. (formerly Bats EDGA Exchange, Inc.)
(``EDGA''), and Cboe EDGX Exchange, Inc. (formerly Bats EDGX
Exchange, Inc.) (``EDGX'').
    \6\ See Securities Exchange Act Release No. 79585 (December 16,
2016), 81 FR 93988 (December 22, 2016) (SR-BatsBZX-2016-68; SR-
BatsBYX-2016-29; SR-BatsEDGA-2016-24; SR-BatsEDGX-2016-60).
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    In connection with the Merger, the Cboe Affiliated Exchanges are
working to migrate Cboe Options and C2 onto the Bats technology
platform, and align certain system functionality, retaining only
intended differences between the Cboe Affiliated Exchanges.\7\ The
Exchange proposes to amend Rule 2.12 to reflect that Cboe Options and
C2 are affiliated with the Exchange and that upon completion of the
migration, Cboe Trading, Inc. (``Cboe Trading'') may also act as the
inbound router for routing orders from Cboe Options and C2 to the
Exchange. The Exchange also proposes to amend Rule 2.12 to update the
defined term ``Cboe Bats Exchange'' to ``Cboe Exchange'' to reflect
that all Cboe Affiliated Exchanges, not just BYX, EDGA, and EDGX, are
included in the definition. The Exchange previously implemented
limitations and conditions on Cboe Trading's affiliation with the
Exchange in order to permit the Exchange to accept inbound orders that
Cboe Trading routes in its capacity as a facility of the Exchange, BYX,
EDGA, and EDGX.\8\ Those same conditions and limitations will apply to
any inbound orders that Cboe Trading routes in its capacity as a
facility of Cboe Options and C2.
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    \7\ It is anticipated that the C2 migration onto the Bats
technology platform will be completed on May 14, 2018, and the Cboe
Options migration onto the Bats technology platform will be
completed on October 7, 2019.
    \8\ See Securities Exchange Act Release No. 62901 (September 13,
2010), 75 FR 57097 (September 17, 2010) (SR-BATS-2010-024) (notice
of filing and immediate effectiveness of proposed rule change to
adopt BATS Exchange, Inc. (currently named Cboe BZX Exchange, Inc.)
Rule 2.12).
---------------------------------------------------------------------------

    Cboe Trading currently provides Members of the Exchange, BYX, EDGA,
and EDGX with optional routing services to other market centers. In
certain circumstances, Cboe Trading provides inbound routing from BYX,
EDGA, or EDGX to the Exchange. Exchange Rule 2.12 governs this inbound
routing of orders by Cboe Trading to the Exchange in Cboe Trading's
capacity as a facility of the Exchange. The Exchange proposes to amend
Rule 2.12 to reflect that Cboe Options and C2 are affiliated with the
Exchange and that Cboe Trading may also act as the inbound router for
routing orders from Cboe Options and C2 to the Exchange upon migration
of Cboe Options and C2 onto the Bats technology platform. The Exchange
does not propose to amend the requirements of this rule. Therefore, the
conditions and limitations set forth in Exchange Rule 2.12(a) will
remain the same. The Exchange believes that Rule 2.12 will continue to
adequately manage the potential for conflicts of interest that could
arise from Cboe Trading routing orders to the Exchange.

Implementation Date
    With respect to C2, the Exchange intends to implement the proposed
rule change on or about May 14, 2018, which is the anticipated date
upon which the migration of C2 onto the Bats technology platform will
be complete. With respect to Cboe Options, the Exchange intends to
implement the proposed rule change on or about October 7, 2019, which
is the anticipated date upon which the migration of Cboe Options onto
the Bats technology platform will be complete.
2. Statutory Basis
    The Exchange believes the proposed rule change is consistent with
the Securities Exchange Act of 1934 (the ``Act'') and the rules and
regulations thereunder applicable to the Exchange and, in particular,
the requirements of Section 6(b) of the Act.\9\ Specifically, the
Exchange believes the proposed rule change is consistent with the
Section 6(b)(5) \10\ requirements that the rules of an exchange be
designed to prevent fraudulent and manipulative acts and practices, to
promote just and equitable principles of trade, to foster cooperation
and coordination with persons engaged in regulating, clearing,
settling, processing information with respect to, and facilitating
transactions in securities, to remove impediments to and perfect the
mechanism of a free and open market and a national market system, and,
in general, to protect investors and the public interest. Additionally,
the Exchange believes the proposed rule change is consistent with the
Section 6(b)(5) \11\ requirement that the rules of an exchange not be
designed to permit unfair discrimination between customers, issuers,
brokers, or dealers.
---------------------------------------------------------------------------

    \9\ 15 U.S.C. 78f(b).
    \10\ 15 U.S.C. 78f(b)(5).
    \11\ Id.
---------------------------------------------------------------------------

    The Exchange does not propose to amend the requirements of the rule
and the proposed rule change is intended only to reflect that Cboe
Options and C2 are affiliated with the Exchange and that Cboe Trading
may also route inbound orders from Cboe Options and C2 to the Exchange
upon migration of Cboe Options and C2 onto the Bats technology
platform. A consistent technology offering through the use of Cboe
Trading by each of the Cboe Affiliated Exchanges will, in turn,
simplify the technology implementation, changes, and maintenance by
users of the Exchange that are also participants on BYX, EDGA, EDGX,
Cboe Options, and C2. As such, the proposed rule change would foster
cooperation and coordination with persons engaged in facilitating
transactions in securities and would remove impediments to and perfect
the mechanism of a free and open market and a national market system.

B. Self-Regulatory Organization's Statement on Burden on Competition

    The Exchange does not believe that the proposed rule change will
impose any burden on competition that is not necessary or appropriate
in furtherance of the purposes of the Act. The Exchange reiterates that
the proposed rule change is being proposed in the context of the
technology integration of the Cboe Affiliated Exchanges. Thus, the
Exchange believes this proposed rule change is necessary to permit fair
competition among national securities exchanges. In addition, the
Exchange believes the proposed rule change will benefit Exchange
participants in that it is one of several changes necessary to achieve
a consistent technology offering by the Cboe Affiliated Exchanges.

C. Self-Regulatory Organization's Statement on Comments on the Proposed
Rule Change Received From Members, Participants, or Others

    The Exchange has not solicited, and does not intend to solicit,
comments on this proposed rule change. The Exchange has not received
any written comments from members or other interested parties.

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

    Because the foregoing proposed rule change does not: (i)
Significantly affect the protection of investors or the public
interest; (ii) impose any significant burden on competition; and (iii)
become operative for 30 days from the date on which it was filed, or
such shorter time as the Commission may designate, it has become
effective pursuant to Section 19(b)(3)(A) of the Act \12\ and Rule 19b-
4(f)(6) thereunder.\13\
---------------------------------------------------------------------------

    \12\ 15 U.S.C. 78s(b)(3)(A).
    \13\ 17 CFR 240.19b-4(f)(6). In addition, Rule 19b-4(f)(6)(iii)
requires a self-regulatory organization to give the Commission
written notice of its intent to file the proposed rule change, along
with a brief description and text of the proposed rule change, at
least five business days prior to the date of filing of the proposed
rule change, or such shorter time as designated by the Commission.
The Exchange has satisfied this requirement.
---------------------------------------------------------------------------

    A proposed rule change filed under Rule 19b-4(f)(6) normally does
not become operative for 30 days after the date of its filing. However,
Rule 19b-4(f)(6)(iii) \14\ permits the Commission to designate a
shorter time if such action is consistent with the protection of
investors and the public interest. The Exchange has requested that the
Commission waive the 30-day operative delay so that the proposed rule
change will become operative on filing. Waiver of the operative delay
would allow the Exchange to implement the proposed rule change on May
14, 2018, which is same day as the anticipated date for the migration
of C2 to the Bats technology platform. The Exchange stated that the
proposed rule change promotes the protection of investors and the
public interest because it would minimize the amount of disruption as
C2 (and eventually Cboe Options) migrates to the Bats technology
platform. Therefore, the Commission believes that waiver of the 30-day
operative delay is consistent with the protection of investors and the
public interest. Accordingly, the Commission hereby waives the
operative delay and designates the proposed rule change operative upon
filing.\15\
---------------------------------------------------------------------------

    \14\ 17 CFR 240.19b-4(f)(6)(iii).
    \15\ For purposes only of waiving the 30-day operative delay,
the Commission also has considered the proposed rule's impact on
efficiency, competition, and capital formation. See 15 U.S.C.
78c(f).
---------------------------------------------------------------------------

    At any time within 60 days of the filing of such proposed rule
change, the Commission summarily may temporarily suspend such rule
change if it appears to the Commission that such action is necessary or
appropriate in the public interest, for the protection of investors, or
otherwise in furtherance of the purposes of the Act. If the Commission
takes such action, the Commission shall institute proceedings to
determine whether the proposed rule change should be approved or
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-CboeBZX-2018-035 on the subject line.

Paper Comments

     Send paper comments in triplicate to Secretary, Securities
and Exchange Commission, 100 F Street NE, Washington, DC 20549-1090.

All submissions should refer to File Number SR-CboeBZX-2018-035. 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 the Exchange. 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-CboeBZX-2018-035, and should be
submitted on or before June 11, 2018.
---------------------------------------------------------------------------

    \16\ 17 CFR 200.30-3(a)(12).

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\16\
Eduardo A. Aleman,
Assistant Secretary.
[FR Doc. 2018-10712 Filed 5-18-18; 8:45 am]
 BILLING CODE 8011-01-P


[Federal Register Volume 82, Number 8 (Thursday, January 12, 2017)]
[Notices]
[Pages 3790-3791]
[FR Doc No: 2017-00547]

=======================================================================
-----------------------------------------------------------------------

ENVIRONMENTAL PROTECTION AGENCY

[FRL 9958-25-OA]

Notice of Meeting of the EPA Children's Health Protection
Advisory Committee (CHPAC)

AGENCY: Environmental Protection Agency.

ACTION: Notice of meeting.

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

SUMMARY: Pursuant to the provisions of the Federal Advisory Committee
Act, Public Law 92-463, notice is hereby given that the next meeting of
the Children's Health Protection Advisory Committee (CHPAC) will be
held February 1 and 2, 2017, at Georgetown University Hotel and
Conference Center, 3800 Reservoir Road NW., Washington, DC 20057.
    The CHPAC advises the Environmental Protection Agency on science,
regulations, and other issues relating to children's environmental
health.

DATES: February 1, 2017, from 1:00 p.m. to 5:30 p.m. and February 2,
2017, from 9:00 a.m. to 4:00 p.m.

ADDRESSES: 3800 Reservoir Road NW., Washington, DC 20057.

FOR FURTHER INFORMATION CONTACT: Martha Berger, Office of Children's
Health Protection, USEPA, MC 1107T, 1200 Pennsylvania Avenue NW.,
Washington, DC 20460,<PHONE_NUMBER> or<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: The meetings of the CHPAC are open to the
public. An agenda will be posted to epa.gov/children.
    Access and accommodations: For information on access or services
for individuals with disabilities, please contact Martha Berger at 202-
564-2191 or<EMAIL_ADDRESS>

    Dated: January 9, 2017.
Martha Berger,
Designated Federal Official.
[FR Doc. 2017-00547 Filed 1-11-17; 8:45 am]
BILLING CODE 6560-50-P


LT2ESWTR Toolbox Guidance Manual Proposal Draft June 2003 8 1 8.0 Bag and Cartridge Filters 8.1 Introduction Under the LT2ESWTR, bag and cartridge filters are defined as pressure driven separation processes that remove particles larger than 1

m using an engineered porous filtration medium ( generally a fabric material) through either surface or depth filtration ( 40 CFR 141.2). Typically, small systems use bag and cartridge filters for protozoa or other particle removal. The pore sizes in the filter bags and cartridges designed for protozoa removal are small enough to remove protozoan cysts and oocysts but generally large enough that viruses, bacteria, and fine colloidal clays could pass through.

The distinction between bag filters and cartridge filters is based on the type of filtration media used and the manner in which the devices are constructed. Bag filters are typically constructed of a non rigid, fabric filtration media housed in a pressure vessel in which the direction of flow is from the inside of the bag to the outside. Cartridge filters are typically constructed as rigid or semi rigid, self supporting filter elements housed in pressure vessels in which flow is from the outside of the cartridge to the inside. A pressure vessel may contain either single or multiple filters in a series or in parallel.

As the water flows through a bag or cartridge filter, particles collect on the filter and the difference in pressure from the inlet to the outlet, termed " pressure drop," increases. Once a " terminal pressure drop" is reached, the bag or cartridge filter must be replaced. Bag and cartridge filters are disposable and designed to be easily replaced; however, a few cartridge filter devices are reportedly designed to be cleaned and operated through multiple filtration cycles.

This chapter provides background information on the treatment performance, design, and operation of bag and cartridge filters, with emphasis on those issues that a system should consider for integrating bag or cartridge filters into its treatment process to comply with the LT2ESWTR. This chapter is organized as follows:

8.2 LT2ESWTR Compliance Requirements  describes criteria and reporting requirements that systems must meet to receive Cryptosporidium treatment credit. 8.3 Toolbox Selection Considerations  describes the advantages and disadvantages of integrating a bag and cartridge filtration process for compliance with the LT2ESWTR.

8.4 Challenge Testing  describes the challenge testing that a bag or cartridge filter must pass to be awarded Cryptosporidium treatment credit for the LT2ESWTR.

8.5 Design Considerations  discusses influent water quality, size of filter system and redundancy, layout features, filter cycling, pressure monitoring, valves and appurtenances, air entrapment, and NSF certification. Chapter 8  Bag and Cartridge Filters LT2ESWTR Toolbox Guidance Manual Proposal Draft June 2003 8 2 8.6 Operational Issues  discusses pressure drop across the filter, and monitoring to assess performance and indicate possible process upsets with the bag or cartridge filter or other upstream processes.

8.2 LT2ESWTR Compliance Requirements 8.2.1 Credits Bag and cartridge filtration processes that meet the EPA definition and demonstrate Cryptosporidium removal through challenge testing may receive the following Cryptosporidium removal credit for the LT2ESWTR ( 40 CFR 141.728( a)):

° 1 log removal for bag filtration showing a minimum of 2 log removal in challenge testing ° 2 log removal for cartridge filtration showing a minimum of 3 log removal in challenge testing A 1 log factor of safety is applied to the allowable removal credit over that demonstrated by challenge testing because bag and cartridge filters cannot have their integrity directly tested; hence, there are no means of verifying their removal efficiency during routine use.

Recently, some cartridge filtration devices have been developed for drinking water treatment using membrane media, which can be direct integrity tested. These membrane cartridge filters ( MCFs) could be considered a membrane filtration process for the purpose of compliance with the LT2ESWTR treatment requirements for Cryptosporidium ( i. e., the MCF process would be eligible for the same credit, and subject to the same requirements, as a membrane filtration process). A direct integrity test is a physical test applied to a membrane unit to identify and isolate integrity breaches ( i. e., one or more leaks that could result in contamination of the filtrate). Manufacturers can provide information on direct integrity testing and whether it is feasible with their products. Refer to the EPA Membrane Filtration Guidance Manual for direct integrity testing and other membrane filtration requirements.

States may choose to award removal credits in excess of 1 and 2 log for bag and cartridge filtration, respectively, if challenge testing demonstrates that the process can reliably achieve a greater removal efficiency.

8.2.2 Reporting Requirements All reporting requirements for the Surface Water Treatment Rule ( SWTR), Interim Chapter 8  Bag and Cartridge Filters LT2ESWTR Toolbox Guidance Manual Proposal Draft June 2003 8 3 Enhanced Surface Water Treatment Rule ( IESWTR), and Long Term 1 Enhanced Surface Water Treatment Rule ( LT1ESWTR) are still applicable; the LT2ESWTR does not modify or replace any previous rule requirements. The location of filter effluent turbidity monitoring for compliance with the IESWTR and LT1ESWTR does not change with the installation of a bag or cartridge filter as a secondary filtration process. That is, a system would still monitor filter effluent turbidity after the primary filters for compliance with the IESWTR and LT1ESWTR.

The LT2ESWTR requires an initial report be submitted by [ 72 months after rule promulgation] for large systems and [ 102 months after rule promulgation] for small systems that demonstrates the following ( 40 CFR 141.730):

° Process meets the definition of a bag or cartridge filter ° Removal efficiency from challenge testing ( described in section 8.4) that must show at least 2 log removal for bag filters and 3 log removal for cartridge filters For routine compliance reporting, the rule requires verification that all flow was treated by the bag or cartridge filter ( 40 CFR 141.730). One possible approach States may elect to use for flow verification is to have operators certify each month that all flow was treated by the filter. States may require additional reporting at their discretion. Section 8.6 provides recommendations for filter effluent and process monitoring.

8.2.3 Integration Into a Treatment Process Train To achieve compliance with the IESWTR and LT1ESWTR, all plants ( except those meeting the filter avoidance criteria in 40 CFR 141.71) must have a filtration process approved by the State. Approved processes receive 2 log Cryptosporidium removal credit under the IESWTR and LT1ESWTR. For compliance with additional treatment requirements for the LT2ESWTR, bag and cartridge filters should be added as an additional filtration process following the existing primary filtration ( see Figures 8.1 and 8.2). The bag and cartridge filters provide additional removal of the smaller contaminants and any contaminants that break through the granular media filters during the end of a run cycle or process upsets. Chapter 8  Bag and Cartridge Filters LT2ESWTR Toolbox Guidance Manual Proposal Draft June 2003 8 4 Raw water Coagulation Flocculation Sedimentation Granular Filters Service pump ( if needed) Bag or Cartridge Filter Clearwell High service pump Distribution System Raw water Primary Bag or Cartridge Filter( s) Clearwell High service pump Distribution System Secondary Bag or Cartridge Filter( s) Figure 8.1 Schematic of Treatment Process with Bag/ Cartridge Filters For those systems using a bag or cartridge filter process to meet LT1ESWTR requirements, thus serving as the primary filtration process, it may be possible to configure the bag or cartridge filters in a series ( see Figure 8.2).

Figure 8.2 Bag/ Cartridge Filters in Series Another possible configuration is a bag or cartridge filter followed by a UV system ( see Figure 8.3). This configuration would allow removal of particles and microbial pathogens as well as inactivation of Cryptosporidium, Giardia, and viruses. In this case, the bag or cartridge filter would serve as the primary filter and thus, be subject to SWTR, IESWTR, and LT1ESWTR requirements, while the UV system would be subject to the LT2ESWTR requirements. Refer to EPA's UV Disinfection Guidance Manual for information regarding UV systems and associated requirements with LT2ESWTR. Chapter 8  Bag and Cartridge Filters LT2ESWTR Toolbox Guidance Manual Proposal Draft June 2003 8 5 Raw water Bag or Cartridge Filter( s) Clearwell High service pump Distribution System UV System Figure 8.3 Bag/ Cartridge Filter with UV System Other factors that should be considered when developing a treatment process scheme include available space, hydraulic profile, and point of disinfection. Space requirements are small for bag and cartridge filter systems, but extra space for maintenance activities should be accounted for in the planning process. Because a significant head loss is associated with an additional filtration process, a utility should consider its hydraulic profile when integrating new filters into an existing process sequence. Although the addition of a new bag filtration process does not necessarily require that the point of primary disinfection be changed, some bag filtration applications chlorinate prior to the bag filtration process to minimize biofilm growth on the bags. However, if considering a process train with a bag or cartridge filter as the primary filter, as in Figure 8.3, chlorinating prior to filtration will likely cause higher disinfection byproduct formation compared to post filter chlorination since the filtration process will remove some organic material.

8.3 Toolbox Selection Considerations This section describes the advantages and disadvantages of integrating a bag and cartridge filtration process for compliance with the LT2ESWTR.

8.3.1 Advantages The advantages of bag and cartridge filtration processes include low maintenance requirements, relatively low capital cost, minimal operator skill and attention required, and low space requirements. The only routine maintenance required is filter replacement when a defined terminal pressure drop or other operating parameter, such as filter age or volume treated, is reached. The operation of these systems is straightforward and requires little technical skill. In addition, the filter materials are relatively inexpensive and the housing system is not complex, resulting in relatively low capital costs. Chapter 8  Bag and Cartridge Filters 1 Specific sections of the EPA/ NSF ETV Protocol that provide guidance for developing and conducting a challenge test for LT2ESWTR include: section 10.4, Pre Filter Water Quality Analysis; section 11.0, Operating Conditions; section 12.3, Workplan; section 13.0, Data Management; and section 14.0, QA/ QC.

LT2ESWTR Toolbox Guidance Manual Proposal Draft June 2003 8 6 8.3.2 Disadvantages A disadvantage of bag and cartridge filtration processes is most filters must be replaced instead of regenerated. For larger flows, or water with higher particle loads, frequent filter replacement increases operation and maintenance costs. Additional pumps may be required to provide needed pressure. Also, redundancy should be built into the process design, increasing costs.

8.4 Challenge Testing Manufacturers commonly rate fabric filters by pore size or pore distribution. However, there is no industry standard for measuring or reporting these characteristics. This lack of standardization causes problems for establishing design criteria to ensure that a given bag or cartridge filter will effectively remove a given percentage of Cryptosporidium. Furthermore, an oocyst has different structural characteristics than the markers used to determine pore size; thus, the rate of rejection may differ for an oocyst versus the test markers used to determine pore size or molecular weight cutoff. To compensate for these factors of uncertainty for Cryptosporidium removal, the LT2ESWTR requires bag or cartridge filters to be challenge tested   a process in which a known quantity of Cryptosporidium oocysts ( or an acceptable surrogate) is added to the filter influent and the effluent concentration is measured to determine the removal capabilities of the filter ( 40 CFR 141.728( a)). This testing is product specific, not site specific, meaning it does not have to be tested at every water system seeking removal credit. Instead, a manufacturer ( or independent third party) would challenge test each of its products in order to obtain a 1 or 2 log Cryptosporidium removal rating.

For compliance with the LT2ESWTR, EPA defined a set of test conditions that must be met for an acceptable challenge test. These conditions provide only a framework for the challenge test and States may develop additional testing requirements. The EPA Membrane Filtration Guidance Manual contains detailed guidance on developing challenge test protocol and conducting the test for membrane processes that relate to these requirements. Additionally, NSF International, in cooperation with EPA, developed the Protocol for Equipment Verification Testing for Physical Removal of Microbiological and Particulate Contaminants with a chapter for testing bag and cartridge filters. Although the protocol was developed for compliance with the SWTR, some1 testing principles still apply.

Section 8.4.1 describes the test conditions required by the LT2ESWTR ( 40 CFR 141, Subpart W, Appendix B). Section 8.4.2 shows how to calculate the log removal value for Chapter 8  Bag and Cartridge Filters LT2ESWTR Toolbox Guidance Manual Proposal Draft June 2003 8 7 challenge testing results. Section 8.4.3 discusses modifications to the filter unit ( e. g., change in filter media) occurring after challenge testing that may require additional challenge testing.

8.4.1 Testing Conditions ( 141, Subpart W, Appendix B)

<IP_ADDRESS> Full Scale Filter Element Challenge testing must be conducted on a full scale filter element identical in material and construction to the filter elements proposed for use in full scale treatment facilities. For this challenge testing, a filter element consists of the filter media, filter housing, and inlet and outlet piping.

<IP_ADDRESS> Challenge Particulate Challenge testing must be conducted using Cryptosporidium oocysts or a surrogate which is removed no more efficiently than Cryptosporidium oocysts. The organism or surrogate used during challenge testing is referred to as the " challenge particulate." The concentration of the challenge particulate must be determined using a method capable of discreetly quantifying the specific organism or surrogate used in the test, and gross measurements such as turbidity cannot be used. Key physical characteristics to be considered for identifying an acceptable surrogate include size, shape, surface charge, and mono dispersion ( i. e., particles remain discrete in solution and do not aggregate).

Chapter 3 of EPA's Membrane Filtration Guidance Manual describes the characteristics of acceptable surrogates and lists potential and inert surrogates for Cryptosporidium. Examples of possible microbial surrogates are P. dimunita and Serratia marcessans.

<IP_ADDRESS> Feed Concentration In order to demonstrate a removal efficiency of at least 2 or 3 log for bag or cartridge filters, respectively, it may be necessary to seed the challenge particulate into the test solution. A criticism of this approach is that the seeded levels are orders of magnitude higher than those encountered in natural waters, which could lead to artificially high estimates of removal efficiency. To address this issue, EPA set a limit on the maximum feed concentration applied to a filter during the challenge study. The limit is based on the detection limit of the challenge particulate:

Cartridge filters: Maximum Feed Concentration = 3.16 × 104 × Filtrate Detection Limit Bag filters: Maximum Feed Concentration = 3.16 × 103 × Filtrate Detection Limit Chapter 8  Bag and Cartridge Filters LT2ESWTR Toolbox Guidance Manual Proposal Draft June 2003 8 8 These concentrations allow the demonstration of up to 3.5 log removal for bag filters and 4.5 log removal for cartridge filters during challenge testing, if the challenge particulate is removed to the detection limit.

<IP_ADDRESS> Time Periods of Challenge Testing The challenge test must run until " terminal pressure drop" is reached. Terminal pressure drop is a parameter specified by the manufacturer which establishes the end of the useful life of the filter. However, continuous challenge particulate feed is not required ( i. e., intermittent seeding is permitted). At a minimum, removal efficiency must be determined during three periods over the filtration cycle:

1) Within 2 hours of start up after a new bag or cartridge filter has been installed.

2) When the pressure drop is between 45 and 55 percent of the terminal pressure drop.

3) At the end of the run after the pressure drop has reached 100 percent of the terminal pressure drop.

The rule does not specify the number of samples that must be collected during each of the three periods. Because the effluent concentration is often very low and near the detection limit, it may be beneficial to collect more effluent than influent samples to obtain a more accurate removal efficiency. If one sample has an uncharacteristically high concentration this can result in a low log removal value ( LRV) that is not necessarily representative of the filter's removal efficiency.

<IP_ADDRESS> Water Quality of Challenge Test Solution Water quality can have a significant impact on the removal of particulate contaminants, such as Cryptosporidium. In general, bag and cartridge filters in water treatment do not experience influent turbidity concentrations much greater than 10 NTU; and for the application of the LT2ESWTR, will receive filtered water and thus, very low turbidity.

A clean water challenge test will generally provide the most conservative estimate of removal efficiency. However, since the challenge test must run until terminal head loss is reached, the challenge test solution will need to contain some solids to cause the head loss build up across the filter, but not an excessive amount that will cause a rapid build up. Particulate foulants that may be appropriate to add to the test solution include clay particles ( such as bentonite or kaolin) or carbon powder, as long as they are not excessively fine sized. Chapter 8  Bag and Cartridge Filters LT2ESWTR Toolbox Guidance Manual Proposal Draft June 2003 8 9 The following are recommended for the challenge test solution:

 High quality water with a low to moderate concentration of suspended solids should be used as the challenge solution. Suspended solids concentration should be high enough to achieve a reasonable rate of headloss buildup, but not so high that the headloss builds up too rapidly to conduct the challenges at the various headloss levels.

 No oxidants, disinfectants, or other pretreatment chemicals should be added to the test solution.

 Characterized with respect to basic water quality parameters, such as pH, turbidity, temperature, and total dissolved solids.

For the initial sampling conducted at zero percent headloss ( see section <IP_ADDRESS>), no particulate foulant needs to be added to the test solution. This can be accomplished if the foulant is injected into the feed stream, rather than fed in batch. In this case the foulant feed pump would not be turned on until the zero percent challenge is completed. If the particulate foulant is added in batch, then the zero percent headloss challenge must be completed before five percent of the terminal headloss is reached.

<IP_ADDRESS> Maximum Design Flow Rate The challenge test must be conducted at the maximum design flow rate specified by the manufacturer.

<IP_ADDRESS> Challenge Particulate Seeding Method There are two basic approaches to seeding: batch seeding and in line injection. In batch seeding, all of the challenge particulates are introduced into the entire volume of test solution and mixed to uniformity. In line injection allows for the continuous or intermittent introduction of challenge particulates into the feed stream entering the bag or cartridge system. While both methods are acceptable, intermittent, in line injection may the most practical seeding method for the testing.

Batch seeding requires the entire test solution to be contained in a reservoir and for the reservoir to be well mixed to ensure a uniform concentration of the seeded particles. Generally, batch seeding is used for small scale systems that only require relatively small amounts of feed solution for testing.

While, in line injection of the challenge particle can be either continuous or intermittent, the intermittent feed may be more practical to conduct the challenge test at the required periods ( i. e., a minimum of beginning, middle, and end of run; see section <IP_ADDRESS>). It is vital that Chapter 8  Bag and Cartridge Filters LT2ESWTR Toolbox Guidance Manual Proposal Draft June 2003 8 10 equilibrium is achieved during each seeding event prior to the collection of feed and filtrate samples.

In line injection delivers the challenge particles from a concentrated stock solution with a known feed concentration ( C stock). The concentration of the stock solution should be 50 to 200 times the desired concentration in the test feed solution ( C feed). The stock solution delivery rate ( SSDR) for in line injection is calculated using the equation below:

SSDR = ( C feed x Q feed ) / C stock Equation 8 1 Where: SSDR = stock solution deliver rate ( gpm) C feed = feed solution concentration (# or mass / volume) Q feed = feed flow ( gpm) C stock = stock solution concentration (# or mass / volume)

The stock solution should be continuously mixed to ensure a uniform concentration of particles are injected into the feed stream.

In line injection requires additional equipment, such as chemical feed pumps, injection ports and in line mixers. A more detailed description of in line injection is available in the Membrane Filtration Guidance Manual ( USEPA, 2003).

<IP_ADDRESS> Challenge Test Solution Volume The total volume of test solution required for the challenge should be the same for the different challenge particle seeding methods. However, the seeded test solution volume can differ for the different methods.

In general, the volume of the test solution depends on filtrate flow rate, test duration, and hold up volume of the test system and can be calculated by the following equation.

V test = ( Q f x T + V sys ) x SF Equation 8 2 Where: V test = Volume of test solution ( gallons) Q f = Filtrate flow rate ( gallons per minute) T = Duration of test ( minutes) V sys = Volume of solution contained within the filter unit( gallons) SF = Safety factor ( dimensionless)

To calculate the total volume of test solution, the T value in the above equation is the time between the initiation of flow to the filter unit to the time the last sample is drawn when terminal Chapter 8  Bag and Cartridge Filters LT2ESWTR Toolbox Guidance Manual Proposal Draft June 2003 8 11 headloss is reached. For batch seeding and continuous in line injection tests, the seeded test solution volume ( V seeded) is the same as the total test solution volume.

For intermittent, in line injection, the seeded test solution volume can be considerably less than that required for batch seeding. To calculate this smaller volume, the equation above can be modified as follows:

V seeded = ( Q f x T seed + V sys + V eq) x SF Equation 8 3 Where: V seeded = seeded test solution volume ( gallons) V eq = volume required to reach feed equilibrium ( gallons) T seed = Duration of sampling ( minutes)

The equilibrium volume ( V eq) is the quantity of seeded test solution needed to pass through the filter to reach a stable feed concentration of the challenge particle. In general, filtrate sampling cannot begin until this volume has passed through the system. A common assumption is that a minimum of three to five system volumes are needed to reach equilibrium ( i. e., V eq  3V sys). The duration of the test, T, does not include time needed to reach equilibrium, as this is accounted for by V eq. Thus, T represents the time necessary to conduct the actual sampling as discussed in section <IP_ADDRESS>). Section 3.10.5 of the Membrane Filtration Guidance Manual ( USEPA, 2003) contains a detailed example of challenge test solution design.

For in line injection of the challenge particles the volume of stock solution needed can be calculated from the seeded test volume as follows:

V stock = ( V seeded x C feed) / ( C stock) Equation 8 4 Where: V stock = volume of stock solution ( gallons) V seeded = seeded test solution volume ( gallons) C feed = feed solution concentration (# or mass / volume) C stock = stock solution concentration (# or mass / volume)

<IP_ADDRESS> Sampling An effective sampling program depends on a detailed sampling plan and the use of appropriate sampling methods, locations, and QA/ QC measures.

Samples can be collected using either grab or composite sampling methods. Grab samples consist of pre determined amounts of water taken from the feed or filtrate streams, while composite samples are of the entire process stream. It is likely that grab sampling methods will be used in the challenge test. Good sampling practices include flushing samples taps, using clean Chapter 8  Bag and Cartridge Filters LT2ESWTR Toolbox Guidance Manual Proposal Draft June 2003 8 12 sample containers and preventing cross contamination of samples. QA/ QC measures include clearly identifying samples, collecting duplicates and using blanks. The time of filtrate sampling should be based on the initiation of seeding for a given sampling period and flow rate. The influent should be sampled just prior to entering the filter ( but at least 10 pipe diameters downstream of the particle injection point and in line mixers). Sampling of the filtrate should occur immediately following the filter, but after any filtrate side instrumentation that may be affected by the sampling.

Sample port design is an important consideration and should ensure that a representative sample is obtained. Poorly designed ports contain large volumes where stagnation may occur ( e. g., large valves and long sample tubes) and pull the sample from the edge of the pipe. A well designed port has a sample quill that extends into the center of the pipe to draw a more representative sample.

Chapter 3 of the Membrane Filtration Guidance Manual ( USEPA, 2003) contains additional information on developing sampling plans and provides schematics of typical sampling apparatuses.

8.4.2 Calculation of Log Removal To determine the maximum feed concentration, use Equation 8 5. To determine the log removal efficiency of the filter process tested, calculate the log removal using Equation 8 6.

Maximum Feed Concentration = 3.16 x 106 x ( Filtrate Detection Limit) Equation 8 5 LRV = Log 10( Feed Concentration)  Log 10( Filtrate Concentration) Equation 8 6 The feed and filtrate concentrations must be expressed in the same units ( number of challenge particulate per unit volume). If the challenge particulate is not detected in the filtrate, then the filtrate concentration is set equal to the detection limit.

Example 1  Determining maximum allowable filtrate concentration If the detection limit of the surrogate test is 2 units/ L then the maximum feed concentration is 3.16 x 106 x ( 2) = 6.32 x 106 Chapter 8  Bag and Cartridge Filters LT2ESWTR Toolbox Guidance Manual Proposal Draft June 2003 8 13 Example 2  Calculating the LRV Feed Concentration 20,000 units/ L Filtrate Concentration 3 units/ L LRV = Log( 20,000)  Log( 3) LRV = 4.30  0.48 = 3.82 The LT2ESWTR does not specify how the feed and effluent concentration must be determined. One possible approach is to use the average of all the feed samples and average of all the filtrate samples. A more conservative approach would be to use the lowest feed concentration and highest filtrate concentration from each filter run.

A challenge test will likely evaluate multiple filters. An LRV must be calculated for each filter tested. The final log removal efficiency assigned to the filter process tested depends on the number of filters tested:

$ If fewer than 20 filters were tested during a challenge study, then the lowest LRV observed would be the removal efficiency assigned to the process.

$ If 20 filters were tested during challenge testing, then the removal efficiency assigned for the process is the 10th percentile of the LRVs observed during the challenge study. ( The percentile is defined by [ i/( n+ 1)] where i is the rank of n individual data points ordered lowest to highest. If necessary the system may calculate the 10th percentile using linear interpolation.)

8.4.3 Modifications to Filtration Unit after Challenge Test If any significant modifications to the filter unit are made after challenge testing, additional challenge testing is required to demonstrate removal efficiency of the modified unit. Significant modifications specified by the rule are, but not limited to:

$ Changes to the filtration media ( e. g., different fabric, change in the filter manufacturing process)

$ Changes to the configuration of the filtration media $ Modifications to the sealing system Chapter 8  Bag and Cartridge Filters LT2ESWTR Toolbox Guidance Manual Proposal Draft June 2003 8 14 8.5 Design Considerations Bag and cartridge filter systems may contain anywhere from one to over twenty filter units. There is no maximum number of filters a system can include; however, membrane or other filtration processes become more practical for larger flows since bag and cartridge filters are generally replaced instead of backwashed or regenerated. A single filter unit is comprised of the filter media ( bag or cartridge), housing, and associated piping and valves. Figure 8.4 shows a typical single filter vessel ( housing).

Figure 8.4 Single Filter Vessel Source: U. F. Strainrite Systems with multiple filters may be designed as a manifold with connective piping between the individual filters in separate housing or alternatively as multiple filters in a single housing. Figures 8.5 and 8.6 show the manifold design and multiple filter vessel design, respectively. Chapter 8  Bag and Cartridge Filters LT2ESWTR Toolbox Guidance Manual Proposal Draft June 2003 8 15 Figure 8.5 Manifold Bag Filter Design Chapter 8  Bag and Cartridge Filters LT2ESWTR Toolbox Guidance Manual Proposal Draft June 2003 8 16 Figure 8.6 Multiple Filter Vessel Source: U. F. Strainrite The designs of bag and cartridge filters are not complex, however, there are a couple of key issues that should be taken into consideration. First, the filter units must be designed integrally with their respective housing systems. Poor fittings can cause leaks and premature failure. Manufacturers can provide individual filter units that can be retrofitted into the existing process or complete filter houses that are skid mounted. It is important to adhere to the manufacturer's instructions on filter installation.

Second, the overall water treatment process design should minimize sudden changes in pressures applied to the bag or cartridge filters. Each time the flow to the filter is interrupted and then restarted, a sudden increase in pressure can occur across the filter unit unless steps are taken to allow for gradual pressure ramp up. The particle load in the filter effluent often increases when the filter cycle begins. A study by McMeen ( 2001) reported that the increase in particle load could be occurring due to the seal at the top of the filter failing when the pressure suddenly increases. Bag filters are especially susceptible to cycling because these pressure fluctuations also increase wear on the fabric and seams, causing premature failure. Section 8.5.4 provides recommendations for reducing filter cycling. Chapter 8  Bag and Cartridge Filters LT2ESWTR Toolbox Guidance Manual Proposal Draft June 2003 8 17 8.5.1 Water Quality As previously described, systems seeking compliance with the LT2ESWTR will most likely integrate a bag or cartridge filter process after the primary filtration process. As a result, influent water quality, with respect to high particulate levels, should not be an issue. However, for systems with existing processes that use coagulants, the presence of residual coagulant in the primary filter effluent may clog the pores of a bag or cartridge filter. Although this will not impair removal efficiency for Cryptosporidium, it will shorten the time until the terminal pressure drop is reached, thus reducing filter life.

Another water quality issue is the potential for biofilm growth on the bag or cartridge filter media. Systems can add a disinfectant prior to the bag or cartridge filters to prevent biofilm growth. ( The filters must be compatible with the disinfectant.)

8.5.2 Size of Filter System and Redundancy Systems should be adequately designed to handle maximum day or maximum instantaneous flow, depending on the existing treatment process design. Prolonged operation at maximum flow velocity wears the filter media at a higher rate than operating at lower flow velocities. The total volume throughput is greater when operating at a flow velocity lower than maximum flow velocity rated for the filter.

A minimum of two bag or cartridge filter housings should be provided to ensure continuous water treatment in the event of failure in the filter operation. For water systems that do not require continuous operation, a State may approve a single filter housing operation. Redundancy in pumps is also recommended to ensure continuous operation.

8.5.3 Design Layout Design layout features that should be considered for most designs are as follows:

$ Piping should be designed to allow isolation of the individual filter units or vessels for maintenance and filter replacement $ Common inlet and outlet headers for the filter units $ Sufficient available head to meet the terminal pressure drop and system demand Chapter 8  Bag and Cartridge Filters LT2ESWTR Toolbox Guidance Manual Proposal Draft June 2003 8 18 8.5.4 Filter Cycling Filter cycling refers to the starting and stopping of the pump or filter operation. This can be problematic with bag filter processes ( cartridge filters are not known to have this problem) in which water is pumped directly from the source to the filter, and then out to the distribution system. In these situations, the filters operate on demand, similar to wells for small systems, and the sudden increase in pressure across the filter causes premature wear and filter failure. For LT2ESWTR compliance, systems with bag filters in a series or followed by UV disinfection should consider the following recommendations for controlling the flow into the filter process to minimize filter cycling.

$ Lengthen the filter runs by reducing the flow as much as possible through the filter.

$ Install or divert the flow to a storage facility ( e. g., pressure tank, clearwell) after the bag filtration process. The stored water can supply the frequent surges in demand and thus reduce the bag or cartridge filter cycling.

During filter start up and other hydraulic surges, bag and cartridge filters often experience an increase in filter effluent turbidity. Systems should consider the following options to improve filtered water quality:

$ Design for filter to waste capability. EPA strongly recommends filtering to waste for the first five minutes of the filter cycle.

$ Install a slow opening and closing valve ahead of the filter to reduce flow surges.

8.5.5 Pressure Monitoring, Valves, and Appurtenances As previously mentioned, once the terminal pressure drop has been reached, the filter should be replaced. At a minimum, pressure gauges should be located before and after the bag or cartridge filter system and should be monitored at least daily. A valve or flow restricter should be installed on the inlet header pipe of the filters to maintain flows below the maximum operating flow for the filters.

8.5.6 Air Entrapment An automatic air release valve should be installed on the top of the filter housing to release any air trapped in the filter. These valves should be checked routinely and properly maintained. Chapter 8  Bag and Cartridge Filters LT2ESWTR Toolbox Guidance Manual Proposal Draft June 2003 8 19 8.5.8 NSF Certification All components used in the drinking water treatment process should be evaluated for contaminant leaching and certified under ANSI/ NSF Standard 61.

8.6 Operational Issues 8.6.1 Pressure Drop ( Inlet/ Outlet Pressures)

The pressure drop across the filter directly relates to the amount of particle build up on the filter material and to the time when the filter should be replaced. Typical pressure drops across a clean filter are 1 to 2 psig ( pounds per square inch gauge) and can increase to a differential of 20 to 30 psig when the terminal pressure drop is achieved. The pressure differential does not increase linearly with run time; the differential pressure increases at a faster rate with the duration of the run or as more material accumulates on the filter. The time between filter replacement is primarily dependent on flow rate, but also on influent water quality and filter material ( i. e., size of pores).

The differential pressure between the inlet and outlet header should be monitored to determine when the filter needs replacement. An alarm could also be linked to the pressure gauge to ensure the operator is alerted.

8.6.2 Monitoring In addition to monitoring the pressure drop across the filter, the influent and effluent turbidity or particle count should be monitored to assess performance and indicate possible process upsets with the bag or cartridge filter or other upstream processes. The recommended monitoring frequency depends on the influent water quality and its variability. At a minimum, the pressure differential and effluent turbidity should be checked daily. During the initial start up phase of a newly integrated bag or cartridge filtration system, monitoring should be more frequent and then can be reduced once the operator becomes familiar with the system. If continuous monitoring of turbidity and/ or pressure differential is employed, the output from the sensors should be sent to an alarm to warn operators of sudden changes in operation, or if the filter element needs replacing.

EPA recognizes turbidity has limitations as an indicator of filter failure or pathogen breakthrough. However, in the absence of a better indicator, monitoring both influent and effluent turbidity over a full run ( i. e., from start to end of the filter life) can provide a performance baseline. The baseline can then be used to indicate process upsets. This method may not be applicable to all systems; since the bag or cartridge filter influent will be filtered water, the difference between influent and effluent turbidity may be too low to provide meaningful data. Chapter 8  Bag and Cartridge Filters LT2ESWTR Toolbox Guidance Manual Proposal Draft June 2003 8 20 Particle counters can be another valuable monitoring tool. If available, periodic checks of influent and effluent particle counts are also recommended to ensure the filter is removing particles in the appropriate size range ( i. e., 4 6 microns). Chapter 8  Bag and Cartridge Filters LT2ESWTR Toolbox Guidance Manual Proposal Draft June 2003 8 21 References McMeen ( 2001). Alternate Filtration: Placing New Technology in an Old Regulatory Box. American Water Works Association, Membrane Conference Proceedings.

NSF International. ( 2000). Protocol for Equipment Verification Testing for Physical Removal of Microbiological and Particulate Contaminants. 40CFR35.6450.

USEPA ( 2002). Draft Membrane Filtration Guidance Manual, April 2002 draft.