[Federal Register Volume 83, Number 225 (Wednesday, November 21, 2018)]
[Notices]
[Pages 58768-58770]
[FR Doc No: 2018-25422]

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OW-2018-0614; FRL-9986-79-OW]

Request for Public Review and Comment: Draft Human Health
Toxicity Assessments for Hexafluoropropylene Oxide Dimer Acid and Its
Ammonium Salt (GenX Chemicals) and for Perfluorobutane Sulfonic Acid
(PFBS) and Related Compound Potassium Perfluorobutane Sulfonate

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice of public comment period.

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SUMMARY: The Environmental Protection Agency (EPA) is announcing a 60-
day public comment period associated with the release of two draft
toxicity assessments for public comment:
     Draft Human Health Toxicity Values for Hexafluoropropylene
Oxide (HFPO) Dimer Acid and its Ammonium Salt (GenX Chemicals).
     Draft Human Health Toxicity Values for Perfluorobutane
Sulfonic Acid (PFBS) and Related Compound Potassium Perfluorobutane
Sulfonate.
    The EPA developed the draft assessments to provide the health
effects information available for GenX chemicals and PFBS and describe
how that information was used to derive draft toxicity values. These
draft toxicity assessments underwent independent, external expert peer
review in June-July 2018. Following closure of this 60-day public
comment period, the EPA will consider the comments, revise the draft
documents, and consider the need for additional peer review, as
appropriate, and then publish final toxicity assessments. The toxicity
assessments for GenX chemicals and PFBS are scientific and technical
reports that include toxicity values associated with potential
noncancer health effects following oral exposure (in this case, oral
reference doses [RfDs]). These assessments evaluate human health
hazards. The toxicity assessments and the values contained within are
not risk assessments as they do not include exposure assessments or
provide a risk characterization. Further, the toxicity assessments do
not address the legal, political, social, economic, or technical
considerations involved in risk management. When issued, the toxicity
assessments can be used by the EPA, states, tribes, and local
communities, along with specific exposure and other relevant
information, to determine, under the appropriate regulations and
statutes, if and when it is necessary to

take action to address potential risk associated with human exposures
to these per- and polyfluoroalkyl substances (PFAS) chemicals.

DATES: Comments must be received on or before January 22, 2019.

ADDRESSES: Submit your comments, identified by Docket ID No. EPA-HQ-OW-
2018-0614, to the public docket at: http://www.regulations.gov. Follow
the online instructions for submitting comments. Once submitted,
comments cannot be edited or withdrawn. The EPA may publish any comment
received to its public docket. Do not submit electronically any
information you consider to be Confidential Business Information (CBI)
or other information whose disclosure is restricted by statute.
Multimedia submissions (audio, video, etc.) must be accompanied by a
written comment. The written comment is considered the official comment
and should include discussion of all points you wish to make. The EPA
will generally not consider comments or comment contents located
outside of the primary submission (i.e., on the web, cloud, or other
file sharing system). For additional submission methods, the full EPA
public comment policy, information about CBI or multimedia submissions,
and general guidance on making effective comments, please visit http://www2.epa.gov/dockets/commenting-epa-dockets.

FOR FURTHER INFORMATION CONTACT:
    For information on the docket, contact the docket manager: Assem
Akram, Docket Manager, EPA Docket Center, telephone:<PHONE_NUMBER>; or
email: [email protected].
    For technical information on GenX chemicals: Dr. Jamie Strong,
Health and Ecological Criteria Division, Office of Water (Mail Code
4304T), Environmental Protection Agency, 1200 Pennsylvania Avenue NW,
Washington, DC 20460; telephone:<PHONE_NUMBER>; or email:
[email protected].
    For technical information on PFBS: Dr. Samantha Jones, National
Center for Environmental Assessment, Office of Research and Development
(Mail Code 8602R), Environmental Protection Agency, 1200 Pennsylvania
Avenue NW, Washington, DC 20460; telephone:<PHONE_NUMBER>; or email:
[email protected].

SUPPLEMENTARY INFORMATION:

I. General Information

    Supporting documents are available in the public docket for this
ICR (under Docket ID number EPA-HQ-OW-2018-0614. The docket can be
viewed online at http://www.regulations.gov or in person at the EPA
Docket Center, WJC West, Room 3334, 1301 Constitution Ave. NW,
Washington, DC. The telephone number for the Docket Center is 202-566-
1744. For additional information about the EPA's public docket, visit
http://www.epa.gov/dockets.

A. Does this action apply to me?

    This request for public comment will not impose any requirements on
anyone. Instead, this action notifies interested parties of the
availability of draft toxicity assessments for GenX Chemicals and PFBS
for public comment. It should be noted that when final these toxicity
assessments may be used by the EPA, states, tribes, and local
communities, along with specific exposure and other relevant
information, to determine, under the appropriate regulations and
statutes, if and when it is necessary to take action to address
potential risk associated with human exposures to these PFAS chemicals.

B. What should I consider as I prepare my comments for the EPA?

    1. Submit your comments, identified by Docket ID No. EPA-HQ-OW-
2018-0614, at https://www.regulations.gov (our preferred method), or
the other methods identified in the ADDRESSES section. Once submitted,
comments cannot be edited or removed from the docket. The EPA may
publish any comment received to its public docket. Do not submit
electronically any information you consider to be Confidential Business
Information (CBI) or other information whose disclosure is restricted
by statute. Clearly mark the part or all of the information that you
claim to be CBI. For CBI information in a disk or CD-ROM that you mail
to the 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
the Code of Federal Regulations (CFR) at 40 CFR part 2. Multimedia
submissions (audio, video, etc.) must be accompanied by a written
comment. The written comment is considered the official comment and
should include discussion of all points you wish to make. The EPA will
generally not consider comments or comment contents located outside of
the primary submission (i.e., on the web, cloud, or other file sharing
system). For additional submission methods, the full EPA public comment
policy, information about CBI or multimedia submissions, and general
guidance on making effective comments, please visit https://www.epa.gov/dockets/commenting-epa-dockets.

II. What are GenX chemicals and PFBS?

    GenX chemicals and PFBS are man-made, fluorinated organic chemicals
that are part of a larger group of manmade chemicals referred to as
per- and polyfluoroalkyl substances (PFAS). PFAS are used in many
applications because of their unique physical properties such as
resistance to high and low temperatures, resistance to degradation, and
nonstick characteristics. GenX is a trade name for a processing aid
technology used to make high-performance fluoropolymers without the use
of perfluorooctanoic acid (PFOA). Hexafluoropropylene oxide (HFPO)
dimer acid and its ammonium salt are the major chemicals associated
with the GenX processing aid technology and the focus of the draft
assessment. PFBS is a four-carbon PFAS that was developed as a
replacement for longer-chain PFAS, which have demonstrated
environmental persistence, long half-lives and bioaccumulation in
humans. PFBS has been integrated into various consumer products and
applications.

III. What are EPA's draft toxicity assessments?

    The EPA's draft toxicity assessments for GenX Chemicals and PFBS
provide information on hazard identification and dose-response,
including draft subchronic and chronic oral reference doses (RfDs) for
each chemical. Overall, the available oral toxicity studies demonstrate
that the liver is particularly sensitive to GenX chemicals, and the
thyroid and kidney are sensitive to PFBS. The draft toxicity
assessments underwent independent, external peer review in June and
July 2018 and were revised accordingly.
    In the risk assessment/risk management paradigm, a toxicity
assessment is on the risk assessment side of the paradigm. The draft
toxicity assessments for GenX chemicals and PFBS address the first two
steps (Step 1. Hazard Identification and Step 2. Dose-Response) of the
four-step risk assessment process described by the National Academy of
Science in 1983 as ``the characterization of the potential adverse
health effects of human exposures to environmental hazards.''

Characterizing risk involves integrating information on hazard, dose-
response, and exposure. For further details about risk assessments see:
https://www.epa.gov/risk/conducting-human-health-risk-assessment.
    When issued, the toxicity values for GenX chemicals and PFBS can be
combined with specific exposure information (Step 3. Exposure
Assessment) by government and private entities to help characterize
(Step 4. Risk Characterization) potential public health risks
associated with exposure to these chemicals. Thus, once the GenX
chemicals and PFBS assessments are issued, the EPA will work with our
state, tribal, and local partners to provide technical assistance,
including information about appropriate regulations and statutes, as
they begin considering the final values in relevant exposure scenarios.
It is the risk management part of the risk assessment/risk management
paradigm where the supporting science, as well as statutory and legal
considerations, risk management options, public health considerations,
cost/benefit considerations, economic factors, social factors, and
other considerations are weighed.
    The EPA recognizes that humans have the potential to be exposed to
complex mixtures of PFAS and other chemicals and pathogens through
drinking water and other exposure sources. The EPA's draft assessments
for GenX chemicals and PFBS focus solely on the potential human health
effects associated with oral exposure to each chemical; they do not
consider potential cumulative (mixture) effects of GenX chemicals and
PFBS or their possible interactions with other PFAS and/or other
chemicals. This would involve a more complex assessment that would need
to consider and evaluate mechanisms of action and endpoints of concern
for each of the chemicals in the mixture.

IV. Why is the EPA releasing draft toxicity assessments for these
chemicals?

    The EPA is issuing the draft toxicity assessments for PFBS and GenX
chemicals for public comment to give interested stakeholders and the
public an opportunity to provide input to the Agency. The public will
have 60 days after publication in the Federal Register to provide
input. At the end of the comment period, the EPA will evaluate the
input, make appropriate revisions, and finalize the toxicity
assessments. Once the toxicity assessments are issued, the EPA will
work with our state, tribal, and local partners to provide technical
assistance, as they begin using the final values in relevant exposure
scenarios to generate risk assessments to support risk management
decisions.

V. Solicitation of Public Comment

    During the 60-day comment period, the EPA is soliciting public
comments regarding the science and technical approaches used in the
derivation of the draft toxicity assessments for GenX chemicals and
PFBS.
    In the PFBS assessment, due to the lack of epidemiological studies
demonstrating adverse effects in humans, the EPA derived candidate
subchronic RfDs (see Section 6.1.1 of the toxicity assessment) and
candidate chronic RfDs (see Section 6.1.2 of the toxicity assessment)
for both thyroid effects and kidney effects in rodent toxicity studies.
In light of the consistent observation of the thyroid effects across
life stages and the greater dose-response sensitivity, relative to the
kidney effects, the EPA is proposing to base the overall subchronic and
chronic RfDs on the thyroid effects and is requesting public review and
comment on this proposal in addition to the approaches and conclusions
in the PFBS assessment. Additionally, as described in Section 6.1 of
the PFBS toxicity assessment, decreased serum total T4 (thyroxine) in
newborn mice was used as the basis for the thyroid-related candidate
RfDs. Peer reviewers provided comments on thyroid effects and this
choice of endpoint. See pages 15-25 and 31-32 in the Response to Peer
Review Comments on the Draft Human Health Toxicity Values for
Perfluorobutane Sulfonic Acid (CASRN 375-73-5) and Related Compound
Potassium Perfluorobutane Sulfonate (CASRN 29420-49-3) for the array of
peer review comments on these topics and the EPA's responses. These
supporting documents are available in the public docket for this ICR
(under Docket ID number EPA-HQ-OW-2018-0614. Comments from the public
are requested on the thyroid effects, this choice of endpoint, as well
as the discussion on thyroid hormone economy in humans and animals (see
Section 6.1 of the PFBS toxicity assessment).
    These draft assessments are not final as described in the EPA's
information quality guidelines, and do not represent Agency policy or
views. The EPA will consider all public comments submitted in response
to this notice when revising these documents.

    Dated: November 14, 2018.
David P. Ross,
Assistant Administrator, Office of Water.
[FR Doc. 2018-25422 Filed 11-20-18; 8:45 am]
BILLING CODE 6560-50-P


  UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

					WASHINGTON, D.C.  20460

OFFICE OF

PREVENTION, PESTICIDES

AND TOXIC SUBSTANCES

01/31/2006

MEMORANDUM

SUBJECT:		METHANEARSONIC ACID (MAA) AND SALTS [MSMA/DSMA] Product
Chemistry Chapter for the Reregistration Eligibility Decision [RED]

		DP Barcode:	D325973

		PC Code(s):    	013802 and 013803

		Chemical Class: Organo Arsenical

FROM:	P. Yvonne Barnes, Chemist

Reregistration Branch 2

Health Effects Division [7509C]

THRU:	Alan Nielsen, Branch Senior Scientist

Reregistration Branch 2

Health Effects Division [7509C]

TO:		Diana Locke, Ph.D., Risk Assessor

Reregistration Branch 2

Health Effects Division [7509C]

  SEQ CHAPTER \h \r 1 The summary analytical chemistry and residue data
document was originally prepared under contract by Dynamac Corporation,
The Dynamac Building 2275 Research Boulevard Rockville, MD 20850-3268.

	METHANEARSONIC ACID (MAA) AND SALTS

	REREGISTRATION ELIGIBILITY DECISION:

	PRODUCT CHEMISTRY CONSIDERATIONS

	Case No. 2395 for PC Codes 013802 and 013806

DESCRIPTION OF CHEMICAL

Methanearsonic acid and its salts are selective post-emergence organic
arsenical herbicides registered for use on cotton, nonbearing fruits
(including almond, apple, cherry, grapefruit, lemon, lime, orange,
peach, pear, pecan, plum/prune, tangerine, walnut), bearing citrus, and
non-crop areas (including lawns and ornamental turf).  Of the five
methanearsonic salts, only the disodium salt (DSMA, PC Code 013802) and
the monosodium salt (MSMA, PC Code 013803) are registered for food/feed
uses and are being supported for reregistration.  There are no active
products registered for the MAA octylammonium and dodecylammonium salts
(PC Codes 013804 and 013805), and there are no registered food/feed uses
for the MAA calcium salt (CAMA, PC Code 013806).  Reregistration of DSMA
and MSMA is being supported by the MAA Research Task Force, which
consists of APC Holding Company, KMG - Bernuth, Inc., and
Luxembourg-Pamol, Inc.

       DSMA

Empirical Formula:	CH3AsNa2O3

Molecular Weight:	183.92

CAS Registry No.:	144-21-8

PC Code:			013802

        MSMA

Empirical Formula:	CH4AsNaO3

Molecular Weight:	161.94

CAS Registry No.:	2163-80-6

PC Code:			013803

IDENTIFICATION OF ACTIVE INGREDIENT

DSMA is a white crystalline solid with a melting point >300 ºC, density
of 1.04 g/mL, vapor pressure of 1 x 10-7 mm Hg, and octanol/water
partition coefficient (log Pow) of <1 at 25 ºC.  DSMA is soluble in
water at 34.1 g/100 mL, and is soluble in methanol (26 g/100 mL) and
hexane (0.0025 g/100 mL).

MSMA is a white crystalline solid with a melting point of 116-121 ºC,
density of 1.65 g/mL, vapor pressure of 1 x 10-5 Pa, and octanol/water
partition coefficient (log Pow) of <1 at 25 ºC.  MSMA is soluble in
water at 104 g/100 mL, is soluble in methanol (16 g/100 mL), and has
limited solubility in hexane (0.005 g/100 mL) at 25 ºC.

MANUFACTURING-USE PRODUCTS

The MAA Research Task Force (MAATF) supports the reregistration of DSMA
and MSMA, which consists of the following conglomerate: APC Holding
Company, Luxembourg-Pamol, Inc., and KMG-Bernuth, Inc.  According to the
MAATF, the registered DSMA and MSMA products  marketed as
manufacturing-use and/or end-use products will become consistent with
the Master Labels issued by the MAA Task Force. Note: The 81% DSMA FI is
repackaged from an EPA-registered product.  Because the methanearsonic
acid salts are List B chemicals, only the technical/technical grade
active ingredients [T/TGAIs] are subject to a reregistration eligibility
decision.

REGULATORY BACKGROUND

DSMA and MSMA was the subject of the Methanearsonic Acid and Salts Phase
4 Reviews dated 03/28/1991 by C. Olinger.  Additional product chemistry
data were required for DSMA and MSMA products.  The status of the
product-chemistry data requirements for the DSMA and MSMA TGAIs and MPs
is presented in the attached data summary Tables 1 through 6.  Refer to
these tables for a listing of the outstanding product-chemistry data
requirements.

CONCLUSIONS

Pertinent product chemistry data requirements that remain unfulfilled
for the DSMA and MSMA T/TGAIs are listed in the tables as well as the
81% DSMA FI.  The 81% DSMA FI is repackaged from an EPA-registered
product, all product chemistry data requirements may be satisfied by
data for the source product.

Provided that the registrants submit the data required in the attached
data summary tables for the DSMA and MSMA TGAIs, and either certify that
the suppliers of beginning materials and the manufacturing processes
have not changed since the last comprehensive product chemistry reviews
or submit complete updated product chemistry data packages, HED has no
objections to the reregistration of DSMA and MSMA with respect to
product chemistry data requirements.

Case No. 2395

Case Name:  Methanearsonic acid salts

Registrant:  Luxembourg-Pamol, Inc.

Product(s):  DSMA TGAI

	PRODUCT CHEMISTRY DATA SUMMARY

Table 1.    Product Chemistry Data Summary for Disodium Methanearsonic
salt  SEQ CHAPTER \h \r 1

OPPTS Guideline Numbers	Luxembourg-Pamol, Inc.

Data Requirements: DSMA [TGAI]

PC Code: 013802

CAS No.: 144-21-8	Master Record Identification [MRID]

Data Requirements Fulfilled

Results

 Or

 *Data Gap

830.1550	Product Identity and Composition

No	* Data Gap

830.1600

	Description of Materials Used to Produce the Product	42388301,

44150401	Yes

	830.1620	Description of Production Process	42388301,

44150401	Yes

	830.1650	Description of Formulation Process

No	* Data Gap

830.1670	Discussion of Formation of Impurities

No	* Data Gap

830.1700	Preliminary Analysis	42053701, 45053702 	YES

	830.1750	Certified Limits

No	* Data Gap

830.1800	Enforcement Analytical Method

No	* Data Gap

830.1900	Submittal of Samples

No	* Data Gap

830.6302	Color	42451102	YES	WHITE

830.6303	Physical State	42451102	YES	CRYSTALINE SOLID

830.6304	Odor	42451102	YES	No Odor

830.6313	Stability to normal and elevated temperatures, metals and metal
ions

No	* Data Gap

830.7000	pH	41982002	Yes

	830.7050	UV/VIS absorption

No	* Data Gap

830.7200	Melting Point/Melting Range	41982001	YES	>300 ºC

830.7220	Boiling Point/Boiling Point Range	Not Applicable

830.7300	Density/Relative Density/Bulk Density	42451102	Yes

	830.7370	Dissociation  Constant	41976201	Yes

	830.7550	Partition coefficient (n-octanol /water) shake flask method
41976202	Yes	Log P O/W  <1.0

830.7560	Partition coefficient (n-octanol /water) generator column
method

See guideline 830.7550

830.7570	Partition coefficient (n-octanol /water) estimation by liquid
chromatography

	830.7840	Water Solubility: Column Elution Method; Shake Flask Method
41602502	Yes

	830.7860	Water solubility, generator column method	See guideline
830.7840

830.7950	Vapor pressure	42120701	Yes	0.0000001 mm Hg at 25 °C

Case No. 2395

Case Name:  Methanearsonic acid salts

Registrant:  APC Holdings, Inc.

Product(s):  DSMA TGAI

	PRODUCT CHEMISTRY DATA SUMMARY

Table 2.   Product Chemistry Data Summary for Disodium Methanearsonic
salt   SEQ CHAPTER \h \r 1

OPPTS Guideline Numbers	APC Holdings

Data Requirements: DSMA [TGAI]

PC Code: 013802

CAS No.: 144-21-8	Master Record Identification [MRID]

Data Requirements Fulfilled

Results

 or

*Data Gap

830.1550	Product Identity and Composition

No	* Data Gap

830.1600

	Description of Materials Used to Produce the Product	42361001	Yes

	830.1620	Description of Production Process	42361001	Yes

	830.1650	Description of Formulation Process

No	* Data Gap

830.1670	Discussion of Formation of Impurities	42053701	Yes

	830.1700	Preliminary Analysis	42053702 	YES

	830.1750	Certified Limits

No	* Data Gap

830.1800	Enforcement Analytical Method

No	* Data Gap

830.1900	Submittal of Samples

No	* Data Gap

830.6302	Color	42451102	YES

	830.6303	Physical State	42451102	YES

	830.6304	Odor	42451102	YES	No Odor

830.6313	Stability to normal and elevated temperatures, metals and metal
ions

No	* Data Gap

830.7000	pH	41982002	Yes

	830.7050	UV/VIS absorption

No	* Data Gap

830.7200	Melting Point/Melting Range	41982001	YES

	830.7220	Boiling Point/Boiling Point Range	See guideline 830.7200

830.7300	Density/Relative Density/Bulk Density	42451102	Yes

	830.7370	Dissociation  Constant	41976201	Yes

	830.7550	Partition coefficient (n-octanol /water) shake flask method
41976202	Yes

	830.7560	Partition coefficient (n-octanol /water) generator column
method	See guideline 830.7550

830.7570	Partition coefficient (n-octanol /water) estimation by liquid
chromatography

	830.7840	Water Solubility: Column Elution Method; Shake Flask Method
41602502	Yes

	830.7860	Water solubility, generator column method	See guideline
830.7840

830.7950	Vapor pressure	42120701	Yes

	Case No. 2395

Case Name:  Methanearsonic acid salts

Registrant:  GB Biosciences Corporation

Product(s):  81% DSMA FI

	PRODUCT CHEMISTRY DATA SUMMARY

Table 3.    Product Chemistry Data Summary for Disodium Methanearsonic
salt   SEQ CHAPTER \h \r 1

OPPTS Guideline Numbers	GB Biosciences Corporation

Data Requirements: 81% DSMA  FI [Technical]

PC Code: 013802, CAS No.: 144-21-8	Master Record Identification [MRID]

Data Requirements Fulfilled

Results

or

*Data Gap

830.1550	Product Identity and Composition  	42051902	Yes	CSF 09/23/1991

830.1600

	Description of Materials Used to Produce the Product

NO	* Data Gap

830.1620	Description of Production Process

NO	* Data Gap

830.1650	Description of Formulation Process

No	* Data Gap

830.1670	Discussion of Formation of Impurities

No	* Data Gap

830.1700	Preliminary Analysis

No	* Data Gap

830.1750	Certified Limits	42051902, CSF 09/23/1991	YES

	830.1800	Enforcement Analytical Method

No	* Data Gap

830.1900	Submittal of Samples

No	* Data Gap

830.6302	Color

No	* Data Gap

830.6303	Physical State

No	* Data Gap

830.6304	Odor

No	* Data Gap

830.6313	Stability to normal and elevated temperatures, metals and metal
ions

No	* Data Gap

830.7000	pH

No	* Data Gap

830.7050	UV/VIS absorption

No	* Data Gap

830.7200	Melting Point/Melting Range

No	* Data Gap

830.7220	Boiling Point/Boiling Point Range

No	* Data Gap

830.7300	Density/Relative Density/Bulk Density

No	* Data Gap

830.7370	Dissociation  Constant

No	* Data Gap

830.7550	Partition coefficient (n-octanol /water) shake flask method

No	* Data Gap

830.7560	Partition coefficient (n-octanol /water) generator column
method

	830.7570	Partition coefficient (n-octanol /water) estimation by liquid
chromatography

	830.7840	Water Solubility: Column Elution Method; Shake Flask Method

No  	* Data Gap

830.7860	Water solubility, generator column method

	830.7950	Vapor pressure

No	* Data Gap

Case No. 2395

Case Name:  Methanearsonic acid salts

Registrant:  Luxembourg-Pamol, Inc.

Product(s):  MSMA TGAI

	PRODUCT CHEMISTRY DATA SUMMARY

Table 4.    Product Chemistry Data Summary for Mono Sodium
Methanearsonic salt   SEQ CHAPTER \h \r 1

OPPTS Guideline Numbers	Luxembourg-Pamol, Inc

Data Requirements: MSMA [TGAI]

PC Code: 013803

CAS No.: 2163-80-6	Master Record Identification [MRID]

Data Requirements Fulfilled

Results

 or

*Data Gap

830.1550	Product Identity and Composition

No	* Data Gap

830.1600

	Description of Materials Used to Produce the Product

No	* Data Gap

830.1620	Description of Production Process	41602701, 42387801	Yes

	830.1650	Description of Formulation Process

No	* Data Gap

830.1670	Discussion of Formation of Impurities	41602701, 42387801	YES

	830.1700	Preliminary Analysis	42387802	YES

	830.1750	Certified Limits

NO	* Data Gap

830.1800	Enforcement Analytical Method

NO	* Data Gap

830.1900	Submittal of Samples

NO	* Data Gap

830.6302	Color	41610001,

42451101	YES	White

830.6303	Physical State	41610001,

42451101	YES	Crystalline

830.6304	Odor	41610001,

42451101	YES	No Odor

830.6313	Stability to normal and elevated temperatures, metals and metal
ions	41610001,

42378601	YES

	830.7000	pH	41610001,

42378601	YES

	830.7050	UV/VIS absorption

No	* Data Gap

830.7200	Melting Point/Melting Range	41789501	YES

	830.7220	Boiling Point/Boiling Point Range	Not Applicable

830.7300	Density/Relative Density/Bulk Density	42451101	YES	1.65 g/ mL
at 25 ºC

830.7370	Dissociation  Constant	41610001	Yes

	830.7550	Partition coefficient (n-octanol /water) shake flask method
    	No	* Data Gap

830.7560	Partition coefficient (n-octanol /water) generator column
method

	830.7570	Partition coefficient (n-octanol /water) estimation by liquid
chromatography

	830.7840	Water Solubility: Column Elution Method; Shake Flask Method
41610001	Yes

	830.7860	Water solubility, generator column method	See guideline
830.7840

830.7950	Vapor pressure	41610001,

41651901	YES	0.00001 Pascal’s

Case No. 2395

Case Name:  Methanearsonic acid salts

Registrant:  APC Holdings, Inc.

Product(s):  MSMA TGAI

	PRODUCT CHEMISTRY DATA SUMMARY

Table 5.   Product Chemistry Data Summary for Mono Sodium Methanearsonic
salt   SEQ CHAPTER \h \r 1

OPPTS Guideline Numbers	APC Holdings, Inc.

Data Requirements: MSMA [TGAI]

PC Code: 013803

CAS No.: 2163-80-6	Master Record Identification [MRID]

Data Requirements Fulfilled

Results or *Data Gap

830.1550	Product Identity and Composition

No	* Data Gap

830.1600

	Description of Materials Used to Produce the Product	41702001	Yes

	830.1620	Description of Production Process	41702001	Yes

	830.1650	Description of Formulation Process

No	* Data Gap

830.1670	Discussion of Formation of Impurities	42474101	YES

	830.1700	Preliminary Analysis	41702002, 42474101	YES

	830.1750	Certified Limits

NO	* Data Gap

830.1800	Enforcement Analytical Method

NO	* Data Gap

830.1900	Submittal of Samples

No	* Data Gap

830.6302	Color	41610001	YES

	830.6303	Physical State	41610001	YES

	830.6304	Odor	41610001	YES	No Odor

830.6313	Stability to normal and elevated temperatures, metals and metal
ions	41610001, 4237801	YES

	830.7000	pH	41610001, 4237801	YES

	830.7050	UV/VIS absorption

No	* Data Gap

830.7200	Melting Point/Melting Range	41789501	YES

	830.7220	Boiling Point/Boiling Point Range	See guideline   830.7200

830.7300	Density/Relative Density/Bulk Density	42451101	YES

	830.7370	Dissociation  Constant	41610001	Yes

	830.7550	Partition coefficient (n-octanol /water) shake flask method

No

	* Data Gap

830.7560	Partition coefficient (n-octanol /water) generator column
method

	830.7570	Partition coefficient (n-octanol /water) estimation by liquid
chromatography

	830.7840	Water Solubility: Column Elution Method; Shake Flask Method
41610001	Yes

	830.7860	Water solubility, generator column method	See guideline
830.7840

830.7950	Vapor pressure	41610001,

41651901	YES

Case No. 2395

Case Name:  Methanearsonic acid salts

Registrant:  GB Biosciences Corporation

Product(s):  59% MSMA T

	PRODUCT CHEMISTRY DATA SUMMARY

Table 6.   Product Chemistry Data Summary for Mono Sodium
Methanearsonic salt   SEQ CHAPTER \h \r 1

OPPTS Guideline Numbers	GB Biosciences Corporation

Data Requirements: MSMA 59% [Technical]

PC Code: 013803

CAS No.: 2163-80-6	Master Record Identification [MRID]

Data Requirements Fulfilled

Results

or

*Data Gap

830.1550	Product Identity and Composition  	42153501	Yes

	830.1600

	Description of Materials Used to Produce the Product	42081201	Yes

	830.1620	Description of Production Process	42081201	Yes

	830.1650	Description of Formulation Process

No	*Data Gap

830.1670	Discussion of Formation of Impurities	41608101	Yes

	830.1700	Preliminary Analysis	41608101	Yes

	830.1750	Certified Limits

No	*Data Gap

830.1800	Enforcement Analytical Method

No	*Data Gap

830.1900	Submittal of Samples

No	*Data Gap

830.6302	Color

No	*Data Gap

830.6303	Physical State

No	*Data Gap

830.6304	Odor

No	*Data Gap

830.6313	Stability to normal and elevated temperatures, metals and metal
ions	41610001, 42378601	Yes

	830.7000	pH

No	*Data Gap

830.7050	UV/VIS absorption

No	*Data Gap

830.7200	Melting Point/Melting Range	41789501	Yes

	830.7220	Boiling Point/Boiling Point Range	See guideline 830.7200

830.7300	Density/Relative Density/Bulk Density

No	*Data Gap

830.7370	Dissociation  Constant	41610001	Yes

	830.7550	Partition coefficient (n-octanol /water) shake flask method

No

	*Data Gap

830.7560	Partition coefficient (n-octanol /water) generator column
method

	830.7570	Partition coefficient (n-octanol /water) estimation by liquid
chromatography

	830.7840	Water Solubility: Column Elution Method; Shake Flask Method
41610001	Yes

	830.7860	Water solubility, generator column method	See guideline
830.7840

830.7950	Vapor pressure	41610001, 41651901	Yes

AGENCY MEMORANDA CITED IN THIS DOCUMENT

CBRS No(s):	8155

DP Barcode(s):	D165463

Subject:		Monosodium methanearsonate (MSMA):  (ID#<PHONE_NUMBER>19);
Luxembourg-Pamol, Inc.:  Response to MSMA (Case No. 2395, Chemical No.
13803) Phase 4 Reregistration Product Chemistry Data Requirements
(Regarding Melting Point Guideline #63-5).

From:		F. Toghrol

To:			B. Briscoe

Dated:		11/20/91

MRID(s):		41789501

CBRS No(s):	RD Memorandum

DP Barcode(s):	D170330

Subject:		Product Chemistry Review of ISK Biotech Disodium
Methanearsonate (EPA Reg. No. 50534-39); Action Code 345.

From:		M. Getz

To:			C. Giles-Parker

Dated:		12/26/91

MRID(s):		42051902

CBRS No(s):	8931

DP Barcode(s):	D171424

Subject:		Reregistration of Monosodium Methanearsonate.  ISK Biotech
Corp.  Product Chemistry.

From:		S. Funk

To:			B. Crompton

Dated:		1/13/92

MRID(s):		42081201

CBRS No(s):	8810

DP Barcode(s):	D170296

Subject:		Reregistration of Disodium Methanearsonate.  Luxembourg-Pamol,
Inc.  Response to Phase 4 Review.

From:		S. Funk

To:			B. Crompton

Dated:		1/13/92

MRID(s):		41982001, 41976201, and 41976202

CBRS No(s):	8811

DP Barcode(s):	D170285

Subject:		Reregistration of Monosodium Methanearsonate.
Luxembourg-Pamol, Inc.  Response to Phase 4 Review of Product Chemistry.

From:		S. Funk

To:			B. Crompton

Dated:		1/13/92

MRID(s):		41651901

CBRS No(s):	8916

DP Barcode(s):	D170574

Subject:		Reregistration of Disodium Methanearsonate.  APC Holdings
(Inter-Ag) Response to Phase 4 Review of Product Chemistry.

From:		S. Funk

To:			B. Crompton

Dated:		1/13/92

MRID(s):		42053701 and 42053702

CBRS No(s):	8916 (Addendum)

DP Barcode(s):	D170574 (Addendum)

Subject:		Reregistration of Disodium Methanearsonate (DSMA).  APC
Holdings (Inter-Ag) Response to Phase 4 Review of Product Chemistry.
Addendum to Memorandum of 1/13/92.

From:		S. Funk

To:			B. Crompton

Dated:		3/11/92

MRID(s):		42053701

CBRS No(s):	8473

DP Barcode(s):	D168029

Subject:		Disodium methanearsonate (DSMA):  (ID#<PHONE_NUMBER>19);
Luxembourg-Pamol, Inc.:  Response to DSMA (Case No. 2395, Chemical No.
013802) Reregistration Product Chemistry Data Requirements (Regarding
Melting Point & pH Guideline # 63-5 & 63-12).

From:		F. Toghrol

To:			B. Briscoe

Dated:		7/6/92

MRID(s):		41982002

CBRS No(s):	8526

DP Barcode(s):	D167786

Subject:		Disodium methanearsonate (DSMA):  (ID#<PHONE_NUMBER>19);
Luxembourg-Pamol, Inc:  Response to DSMA (Case No. 2395, Chemical No.
013802) Reregistration Product Chemistry Data Requirements (Regarding
Dissociation Constant, Octanol/Water Partition Coefficient, and
Stability (Guideline # 63-10, 63-11, & 63-13)).

From:		F. Toghrol

To:			B. Briscoe

Dated:		7/6/92

MRID(s):		41976203

CBRS No(s):	10535

DP Barcode(s):	D182274

Subject:		Reregistration of Monosodium Methanearsonate (MSMA).
Luxembourg-Pamol, Inc.  Product Chemistry {Guideline 63}.  (Case No.
2395, Chemical No. 13803).

From:		D. McNeilly

To:			B. Crompton

Dated:		10/26/92

MRID(s):		42451101

CBRS No(s):	10542

DP Barcode(s):	D182275

Subject:		DSMA (Disodium Methanearsonate) Reregistration.  Product
Chemistry Guideline 63-7:  Bulk Density or Specific Gravity.  Response
to Phase IV Review and 63 Series Status Report.

From:		A. Aikens

To:			B. Briscoe/B. Crompton

Dated:		10/27/92

MRID(s):		42451102

CBRS No(s):	9143, 10156, and 10216

DP Barcode(s):	D172598, D180025, and D180715

Subject:		DSMA Reregistration:  a List B Chemical (Chemical No.:
013802; Case No. 2395).  Registrants Response to the DSMA Product
Chemistry Data Requirements.

From:		F. Toghrol

To:			L. Rossi/B. Briscoe

Dated:		2/8/93

MRID(s):		42388301, 42388302, 42361001, and 42120701

CBRS No(s):	10527

DP Barcode(s):	D182420

Subject:		Monosodium methanearsonate (MSMA):  Luxembourg-Pamol, Inc.
Response to MSMA (Case No. 2395; Chemical No. 013803) Reregistration
Product Chemistry Data Requirements (Regarding Guideline # 61-1,
61-2(a), & 62-1 to 62-3).

From:		F. Toghrol

To:			B. Briscoe

Dated:		2/9/93

MRID(s):		42387801 and 42387802

CBRS No(s):	10254

DP Barcode(s):	D180533

Subject:		MSMA (Methanearsonic Acid and Salts):  MAA Research Task Force
Three.  Response to the Phase IV Review dated (3/28/91):  Product
Chemistry Guidelines 63-12 and 63-13.  (Chemical No. 013803)

From:		A. Aikens

To:			B. Briscoe/B. Crompton

Dated:		2/22/93

MRID(s):		42378601

CBRS No(s):	10622

DP Barcode(s):	D182871

Subject:		Monosodium methanearsonate (MSMA) Reregistration:  a List B
Chemical.  APC Holdings, Inc. Response to MSMA (Case No. 2395, Chemical
No. 013803) Reregistration Product Chemistry Data Requirements
(Regarding Guideline # 61-2 & 62-1).

From:		F. Toghrol

To:			B. Briscoe

Dated:		2/25/93

MRID(s):		41702001, 41702002, and 42474101

DP Barcode(s):	D235020

Subject:		MSMA and DSMA; EPA Reg. Nos. 42519-1 and -7.  PC Codes 013801
and 013802.  List B Reregistration Case 2395.  Supplemental Product
Chemistry.

From:		K. Dockter

To:			L. Werrell

Dated:		5/17/99

MRID(s):		41602502, 41602701, 41610001, 42387801, and 42451102

DP Barcode(s):	D265640

Subject:		Product Chemistry Review of Luxembourg-Pamol DSMA 81% EP;
Revised Manufacturing Process.

From:

To:

Dated:		Currently under review

MRID(s):		44150401

PRODUCT CHEMISTRY CITATIONS

Bibliographic citations include only MRIDs containing data which fulfill
data requirements.

References (cited):

41602502  Pesselman, R. (1990) Solvent Solubility Determination of
Methanearsonate (DSMA):  Final Report:  Lab Project Number:  6001-577.
Unpublished study prepared by Hazleton Laboratories America, Inc.  41 p.

41602701  MAA Research Task Force. (1990) MSMA 6.6:  Product Identity
and Composition.  Unpublished study.  9 p.

41608101  Peplowski, M. (1990) Product Identity and Disclosure of
Ingredients:  Arsonate Liquid/Ansar 6.6 (MSMA).  Unpublished study by
Fermenta ASC Corp.  7 p.

41608104  Mizner, D. (1990) Ansar 6.6 Preliminary Analyses:  Lab Project
Number:  PC-90-MAP-001.  Unpublished study prepared by Fermenta ASC
Corp.  9 p.

41608107  Fraley, R. (1990) Determination of Physical and Chemical
Characteristics of Arsonate Liquid/Ansar 6.6 (MSMA):  Lab Project
Number:  PC-90-RWF-001-01; PC-90-RWF-002-01; PC-90-RWF-003-01.
Unpublished study prepared by Fermenta ASC Corp., Formulation Lab.  115
p.

41610001  MAA Research Task Force Three (1990) MSMA 6.6:  Physical and
Chemical Characteristics:  Final Reports:  Lab Project Number:
1081-89-0355-AS-001; HLA 6001-575.  Unpublished study.  234 p.

41651901  Lorence, P. (1989) Monomethylarsonic Acid.  Determination of
Vapor Pressure.  Unpublished study prepared by Fermenta ASC Corp. 50 p.

41702001  Haefele, L. (1990) Product Identity and Composition:  MSMA
660.  Unpublished study prepared by Drexel Chemical Co.  24 p.

41702002  Haefele, L. (1990) Analysis and Certification of Ingredient
Limits - MSMA 660.  Unpublished study prepared by Drexel Chemical Co. 18
p.

41789501  Pesselman, R. (1991) Melting Point/Melting Range
Determination of Synthetically Prepared Monosodium Methanearsonate
(MSMA): LabProject Number: HWI 6001-685.  Unpublished study prepared by
Hazleton Wisconsin, Inc.  23 p.

41976201  Pesselman, R. (1991) Dissociation Constant Determination of
DSMA Lab Project Number:  6366-102.  Unpublished study prepared by
Hazleton Wisconsin, Inc.  35 p.

41976202  Pesselman, R. (1991) Octanol/Water Partition Coefficient
Determination of DSMA: Lab Project Number:  6366-101.  Unpublished study
prepared by Hazleton Wisconsin, Inc.  39 p.

41976203  Pesselman, R. (1991) Stability Determination of DSMA:  Lab
Project Number: 6366-105.  Unpublished study prepared by Hazleton
Wisconsin, Inc.  35 p.

41982001  Pesselman, R. (1991) Melting Point/Melting Range Determination
DSMA:  Final Report:  Lab Project Number:  HWI 6366-104.  Unpublished
study prepared by Hazleton Wisconsin, Inc.  21 p.

41982002  Pesselman, R. (1991) Ph Value Determination of DSMA:  Final
Report:  Lab Project Number:  HWI-6366-100.  Unpublished study prepared
by Hazleton Wisconsin, Inc.  19 p.

42051902  Owens, E. (1991) Product Identity and Disclosure of
Ingredients Disodium Methanearsonate Technical Grade (DSMA).
Unpublished study prepared by ISK Biotech Corp.  7 p.

42053701  Haefele, L. (1991) Product Identity and Compostion: DSMA
Products.  Unpublished study prepared by Drexel Chemical Co.  25 p.

42053702  Haefele, L. (1991) Analysis and Certification of Ingredient
Limits:  DSMA Products.  Unpublished study prepared by Drexel Chemical
Co.  18 p.

42081201 Lightsey, D. (1991) Description of Starting Materials and
Manufacturing Process for Arsonate Liquid. Amendment #1.  Unpublished
study prepared by ISK Biotech 12p.

42120701  Pesselman, R. (1991) Vapor Pressure Determination of DSMA:
Lab Project Number:  HWI 6366-103.  Unpublished study prepared by
Hazleton Wisconsin, Inc.  36 p.

42153501  Owens, E. (1991) Confidential Statement of Formulation:
Arsonate Liquid/Ansar 6. 6 (MSMA)/Daconate Super.  Unpublished study
prepared by ISK Biotech Corp.  6 p.

42361001  Haefele, L. (1992) Supplement to Product Chemistry--DSMA
Products.  Unpublished study prepared by Drexel Chemical Co. 13 p.

42378601  Pesselman, R. (1992) Final Report:  Series 63 Product
Chemistry Determinations of Monosodium Methanearsonate, MSMA (pH and
Stability):  Lab Project Number:  6366-108.  Unpublished study prepared
by Hazleton Wisconsin, Inc.  34 p.

42387801  Bellet, E. (1992) Target 6.6:  Product Identity and
Composition.  Unpublished study prepared by Chemical Consultants
International, Inc.  9 p.

42387802  Bellet, E. (1992) Target 6. 6:  Analytical Methods.
Unpublished study prepared by Chemical Consultants International, Inc.
11 p.

42388301  Bellet, E. (1992) DSMA 81 P:  Product Identity and
Composition.  Unpublished study prepared by Chemical Consultants
International.  9 p.

42388302  Bellet, E. (1992) DSMA 81 P:  Analytical Methods.  Unpublished
study prepared by Chemical Consultants International, Inc.  10 p.

42451101  Bellet, E. (1992) Target 6.6:  Physical and Chemical
Characteristics.  Unpublished study prepared by Consultants Intl., Inc.
6 p.

42451102  Bellet, E. (1992) DSMA 81 P:  Physical and Chemical
Characteristics.  Unpublished study prepared by Chemical Consultants,
Inc.  5 p.

42474101  Haefele, L. (1992) Supplement to Product Chemistry:  MSMA
Unpublished study prepared by Drexel Chemical Co.  11 p.

44150401  Eldan, M., comp. (1996) Revised Manufacturing Process and
Discussion of Impurities for DSMA 81P.  Unpublished study prepared by
Chemical Consultants International, Inc.  7 p.

 PAGE

 PAGE   1


TABLE 2: ANNUAL BURDEN of REPORTING RECORDKEEPING REQUIREMENTS as a RESULT OF STANDARDS FOR MUNICIPAL WASTE COMBUSTORS Person/ hr/ Occurrence/ Person hr/ Number of Total annual Industry Activity Occurrence plant/ yr Respondent Respondent person hrs cost/ yr 1. Applications N/ A 2. Survey & Studies N/ A 3. Reporting Requirements A. Read instructions 1 1 1 20 20 718 B. Required Activities Initial Performance Test for Eb 1077 1 1077 4 4308 154,614 Repeat Performance Test for Eb 1077 1 1077 0.8 861.6 30,923 Demonstration/ CEMs for Eb 494 1 494 4 1976 70,919 Repeat CEM Demonstration Eb 494 1 494 0.8 395.2 14,184 Annual Compliance Test for Ea 850 1 850 32 27200 976,208 Annual Compliance Test for Eb 1077 1 1077 8 8616 309,228 Appendix F audit for Ea in situ ( 1) 125 8 1000 0 0

extractive ( 1) 36 8 288 0 0

C. Create Information Included in 3B D. Gather Existing Info Included in 3E E. Write Report Notify of constr/ reconst for Ea ( 1) 2 1 2 0 0

Notify of anticipated startup Ea ( 1) 2 1 2 0 0

Notify of actual startup for Ea ( 1) 2 1 2 0 0

Notify of initial performance test Ea ( 1) 2 1 2 0 0

Notify of CMS demonstration for Ea ( 1) 2 1 2 0 0

Notify of construct/ reconstruct for Eb 2 1 2 4 8 287 Notify of initial perform. test Eb 2 1 2 4 8 287 Quarterly compliance reports for Ea 16 4 64 32 2048 73,503 Qtrly opacity reports for Ea ( 80% no excess rpt) 8 4 32 16 512 18,376 Qtrly opacity reports for Ea ( 20% excess rpt) 16 4 64 6 384 13,782 Qtrly report of daily weight of MSW & fuel for Ea 34 4 136 32 4352 156,193 Appdx F quarterly reports for Ea 11 4 44 32 1408 50,533 Initial compliance report for Eb 40 1 40 4 160 5,742 Annual compliance report for Eb 40 1 40 4 160 5,742 Semiannual excess emission report Eb 17 2 34 4 136 4,881 Appdx F quarterly reports for Eb 11 4 44 4 176 6,317 Initial site selection analysis/ report Eb 270 1 270 4 1080 38,761 Public mtg & comment response for Eb 140 1 140 4 560 20,098 SUBTOTAL: REPORTING BURDEN 54,369 1,951,296 Person/ hr/ Occurrence/ Person hr/ Number of Total annual Industry TABLE 2: ANNUAL BURDEN of REPORTING RECORDKEEPING REQUIREMENTS as a RESULT OF STANDARDS FOR MUNICIPAL WASTE COMBUSTORS Activity Occurrence plant/ yr Respondent Respondent person hrs cost/ yr 4. Recordkeeping Requirements A. Read Instructions Included in 3A B. Plan Activities Plan Activities for Ea Included in 4C Plan Activities for Eb Included in 4E C. Implement Activities for Eb Included in 4E D. Develop Record System Included in 4E E. Time to enter information record of startup/ shutdown/ malfunction Ea 1.5 104 156 32 4,992 179,163 record of emission measurements Ea 1.5 104 156 32 4,992 179,163 record of employee review of operation Ea 4 2 8 32 256 9,188 record of startup/ shutdown/ malfunction Eb 1.5 94 141 8 1,128 40,484 record of emission rates, computation, test Eb 1.5 94 141 8 1,128 40,484 record of employee review of operation Eb 4 2 8 8 64 2,297 record of amt of sorbent for Hg control for Eb 0.1 94 9.4 8 75 2,699 F. Time to train personnel Included in 4E G. Time for audits Included in 3E SUBTOTAL: RECORDKEEPING BURDEN 12,635 453,477 TOTAL ANNUAL BURDEN TO INDUSTRY: 67,004 2,404,774 ( 1) no new Ea units for these startup actiivities TABLE 1: ANNUAL BURDEN COST FOR THE FEDERAL GOVERNMENT ( A) ( B) ( C) ( D) ( E)

EPA hr/ Occurrences/ Respondent/ EPA hr/ EPA cost/

Activity Occurrence Respondent/ yr year year year Initial Performance Tests for Ea ( 1) 180 1 0 0 0 Review report of initial performance test for Ea ( 1) 24 1 0 0 0 Repeat performance test for Ea 0  immediate retest preparation( 1) 12 1 0 0 0  retest observed ( 1) 360 1 0 0 0  delayed retest ( 1) 30 1 0 0 0  delayed retest observed ( 1) 360 1 0 0 0 Observed initial performance test for Eb 32 1 0.3 0 Repeat performance test for Eb 0  retest preparation 12 1 0.006 0.072 2.66256  retest observed 32 1 0.006 0.192 7.10016 Report Review for Ea 0  notified of construction ( 1) 2 1 0 0 0  notified of anticipated start up( 1) 2 1 0 0 0  notified of actual start up ( 1) 2 1 0 0 0  notified of initial test ( 1) 2 1 0 0 0  notified of CMS demonstration ( 1) 12 1 0 0 0 Review CEMS demonstration for Ea ( 1) 96 1 0 0 0 Report Review for Eb 0  notified of construction 2 1 1 2 73.96  notified of anticipated start up 2 1 1 2 73.96  notified of actual start up 2 1 1 2 73.96  notified of initial performance test 8 1 1 8 295.84  notified of CEMS demonstration 5 1 1 5 184.9 Review CEMS demonstration for Eb 40 1 1 40 1479.2 Review quarterly excess emission reports for Ea 0  excess emission report 2 1 1.4 2.8 103.544  non excess emmsion report 8 1 5.6 44.8 1656.704 Review semiannual excess emission reports for Eb 12 1 1 12 443.76 Review quarterly Appdx F reports for Ea 0.5 1 7 3.5 129.43 Review quarterly compliance reports for Ea 8 1 7 56 2070.88 Review annual compliance reports for Eb 5 1 1 5 184.9 Review annual compliance tests for Ea 18 1 7 126 4659.48 Review siting requirement study for Eb 24 1 1 24 887.52 TOTAL BURDEN 333 12,328 ( 1) no new Ea units for these startup activities Table 2: Annual Industry Burden ( A) Emission ( B) ( C) ( D) ( E) Tech hr/ yr Mgmt hr/ yr Cler. hr yr Emission Person/ hr/ Contractor Occurrence/ Person hr/ Number of at $ 55.34 at $ 78.54 at $ 35.64 Contract/ hr/ yr Total labor Activity Occurrence hr/ occur. plant/ yr Respondent Respondent ( CxD) ( E x. 05) ( E X0.1) at $ 80.00 cost/ yr 1. Applications N/ A 2. Survey & Studies N/ A 3. Reporting Requirements A. Read instructions 1 0 1 1 4 4 0 0 0 251 B. Required Activities Initial Performance Test for Eb 24 1053 1 24 1 24 1 2 1053 85,748 Repeat Performance Test for Eb 24 1053 1 24 0.2 5 0 0 211 17,150 Demonstration/ CEMs for Eb 24 470 1 24 1 24 1 2 470 39,108 Repeat CEM Demonstration Eb 24 470 1 24 0.2 5 0 0 94 7,822 Annual Compliance Test for Ea 24 826 1 24 7 168 8 17 5782 473,116 Annual Compliance Test for Eb 24 1053 1 24 1 24 1 2 1053 85,748 Appendix F audit for Ea 0 in situ ( 1) 125 0 8 1000 0 0 0 0 0 0 extractive ( 1) 36 0 8 288 0 0 0 0 0 0 C. Create Information Included in 3B 0 D. Gather Existing Info Included in 3E 0 E. Write Report 0 Notify of constr/ reconst for Ea ( 1) 2 0 1 2 0 0 0 0 0 0 Notify of anticipated startup Ea ( 1) 2 0 1 2 0 0 0 0 0 0 Notify of actual startup for Ea ( 1) 2 0 1 2 0 0 0 0 0 0 Notify of initial performance test Ea ( 1) 2 0 1 2 0 0 0 0 0 0 Notify of CMS demonstration for Ea ( 1) 2 0 1 2 0 0 0 0 0 0 Notify of construct/ reconstruct for Eb 2 0 1 2 1 2 0 0 0 126 Notify of initial perform. test Eb 2 0 1 2 1 2 0 0 0 126 Quarterly compliance reports for Ea 16 0 4 64 7 448 22 45 0 28,148 Qtrly opacity reports for Ea ( 80% no excess rpt) 8 0 4 32 5.6 179 9 18 0 11,259 Qtrly opacity reports for Ea ( 20% excess rpt) 16 0 4 64 1.4 90 4 9 0 5,630 Qtrly report of daily weight of MSW & fuel for Ea 34 0 4 136 7 952 48 95 0 59,815 Appdx F quarterly reports for Ea 11 0 4 44 7 308 15 31 0 19,352 Initial compliance report for Eb 40 0 1 40 1 40 2 4 0 2,513 Annual compliance report for Eb 40 0 1 40 1 40 2 4 0 2,513 Semiannual excess emission report Eb 17 0 2 34 1 34 2 3 0 2,136 Appdx F quarterly reports for Eb 11 0 4 44 1 44 2 4 0 2,765 Initial site selection analysis/ report Eb 270 0 1 270 1 270 14 27 0 16,964 Public mtg & comment response for Eb 140 0 1 140 1 140 7 14 0 8,796 SUBTOTAL: REPORTING BURDEN 2,802 140 280 8,663 869,086 ( A) Emission ( B) ( C) ( D) ( E) Tech hr/ yr Mgmt hr/ yr Cler. hr yr Emission Person/ hr/ Contractor Occurrence/ Person hr/ Number of at $ 55.34 at $ 78.46 at $ 35.64 Contract/ hr/ yr Total labor Activity Occurrence hr/ occur. plant/ yr Respondent Respondent ( CxD) ( E x. 05) ( E X0.1) at $ 80.00 cost/ yr 4. Recordkeeping Requirements A. Read Instructions Included in 3A B. Plan Activities Plan Activities for Ea Included in 4C Plan Activities for Eb Included in 4E C. Implement Activities for Eb Included in 4E D. Develop Record System Included in 4E E. Time to enter information record of startup/ shutdown/ malfunction Ea 1.5 0 104 156 7 1092 55 109 0 68,611 record of emission measurements Ea 1.5 0 104 156 7 1092 55 109 0 68,611 record of employee review of operation Ea 4 0 2 8 7 56 3 6 0 3,519 record of startup/ shutdown/ malfunction Eb 1.5 0 94 141 1 141 7 14 0 8,859 record of emission rates, computation, test Eb 1.5 0 94 141 1 141 7 14 0 8,859 record of employee review of operation Eb 4 0 2 8 1 8 0 1 0 503 record of amt of sorbent for Hg control for Eb 0.1 0 94 9.4 1 9 0 1 0 591 F. Time to train personnel Included in 4E G. Time for audits Included in 3E SUBTOTAL: RECORDKEEPING BURDEN 2,539 127 254 159,553 TOTAL ANNUAL BURDEN TO INDUSTRY: 5,342 267 534 8,663 1,028,639 ( 1) no new Ea units for these startup actiivities


1 Summary of Summary of EPA Ethics Review EPA Ethics Review Cain, W. ( 2004) Human Sensory Irritation Testing for Chloropicrin. Unpublished study prepared by Chemosensory Perception Laboratory, Univ. of California

San Diego under Project No. PIC 1. 378 p. MRID 46443801 Supplemented by Watson, S. ( 2005) Letter dated April 12, 2005, to Kelly White, EPA, transmitting partial responses to EPA letter of March 3, 2005, seeking additional information about the research reported in MRID 46443801. 278 p. MRID 46566501. 2 Chloropicrin Study Summary Chloropicrin Study Summary

Multi phase study of sensory thresholds

Conducted at UC San Diego in 2001 04

UC SD held a FWA from OHRP

Overseen by UC SD Human Subjects Committee

Original submission had many gaps in documentation of ethical conduct

Supplement was disorganized, but filled the key gaps 3 Chloropicrin Study Chloropicrin Study " Framework Framework"

1. Value  Explores the lower threshold of human sensitivity to chloropicrin, and the relationship between sensory awareness of chloropicrin and potential effects of exposure to it  Information is of potential value in assessing bystander and worker exposure and risks  Funded by Chloropicrin Manufacturers Task Force  Submitted to EPA and CDPR 2. Scientific Validity: Defer to others 4 Chloropicrin Study Chloropicrin Study " Framework Framework"  2 3. Subject Selection  127 subjects; 25 participated more than once  Mostly college students, men and women 18 35  Well documented screening factors excluded pregnant females, and were otherwise consistent with the scientific goals of the study.

 Racial make up of the subject group closely matches the demographics of the student population at UC SD  No indication that any members of particularly susceptible groups were recruited. 5 Chloropicrin Study Chloropicrin Study " Framework Framework"  3 4. Risk Benefit Ratio  Risks characterized as irritation in the nose, throat, and eyes that could be sharp enough to cause blinking and tearing, but expected to be short lasting  Dose levels set well below those reported to cause significant adverse effects, and consistent with standards for occupational exposure set by ACGIH and OSHA  Potential societal benefits discussed at length in the study report, and briefly in the IC materials  No discussion of how expected societal benefits were weighed against risks to subjects 6 Chloropicrin Study Chloropicrin Study " Framework Framework"  4 5. Independent Ethics Review  Overseen by the UC SD Human Subjects Committee, an IRB registered with OHRP  The report does not mention the Common Rule  Compliance asserted with the requirements of the Human Research Protections Program of the UC SD  During the period of this research UC SD held a Federal Wide Assurance from OHRP 7 Chloropicrin Study Chloropicrin Study " Framework Framework" 5 6. Informed Consent  Consent process summarized in the report,

cited an SOP not provided  All subjects asserted to have provided informed consent  IC materials included in the report met all Common Rule requirements 8 Chloropicrin Study Chloropicrin Study " Framework Framework"  6 7. Respect for Subjects  Subject privacy was protected  Subjects were free to withdraw at any time  Some did leave the chamber during some exposures 9 Chloropicrin Study:

Chloropicrin Study:

Prevailing Standards Prevailing Standards

Conducted in US in 2001 04 at UC SD

Cites and asserts compliance with UC SD Human Research Protection Program

UC SD held Federal Wide Assurance at time of research, promising full compliance with Common Rule

Common Rule and FIFRA § 12( a)( 2)( P) are applicable standards 10 Comparison to Prevailing Standards Comparison to Prevailing Standards

No noteworthy ethical deficiencies are apparent when this study is reviewed against the standards of the Common Rule

No noteworthy deficiencies are apparent with this study is reviewed against the requirements of FIFRA § 12( a)( 2)( P) 11 Chloropicrin Study Summary Chloropicrin Study Summary

Remaining gaps in the record are not " clear and convincing evidence"

No evidence that the research was fundamentally unethical

§ 26.1703 does not prohibit reliance on this study  All subjects were at least 18  Female subjects were tested to ensure they were not pregnant

No noteworthy ethical deficiencies relative to prevailing standards 12 Charge Questions Charge Questions

Is there clear and convincing evidence that the conduct of the Cain study was fundamentally unethical?

Is there clear and convincing evidence that the conduct of the study was significantly deficient relative to the ethical standards prevailing at the time the research was conducted?


[Federal Register Volume 83, Number 25 (Tuesday, February 6, 2018)]
[Rules and Regulations]
[Page 5210]
[FR Doc No: 2018-02353]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 300

[EPA-HQ-SFUND-1994-0009; FRL-9973-62-Region 10]

National Oil and Hazardous Substances Pollution Contingency Plan;
National Priorities List: Deletion of the Vancouver Water Station #1
Superfund Site

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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

SUMMARY: The Environmental Protection Agency (EPA) Region 10 announces
the deletion of the Vancouver Water Station #1 Superfund Site (Site)
located in Vancouver, Washington, from the National Priorities List
(NPL). The NPL, promulgated pursuant to section 105 of the
Comprehensive Environmental Response, Compensation, and Liability Act
(CERCLA) of 1980, as amended, is an appendix of the National Oil and
Hazardous Substances Pollution Contingency Plan (NCP). The NPL refers
to the Site as the Vancouver Water Station #1 Contamination Superfund
Site. The EPA and the State of Washington, through the Department of
Ecology, have determined that all appropriate response actions under
CERCLA have been completed. However, this deletion does not preclude
future actions under Superfund.

DATES: This action is effective February 6, 2018.

ADDRESSES: Docket: EPA has established a docket for this action under
Docket Identification No. EPA-HQ-SFUND-1994-0009. All documents in the
docket are listed on the http://www.regulations.gov website. Although
listed in the index, some information is not publicly available, i.e.,
Confidential Business Information or other information whose disclosure
is restricted by statute. Certain other material, such as copyrighted
material, is not placed on the internet and will be publicly available
only in hard copy form. Publicly available docket materials are
available either electronically through http://www.regulations.gov or
in hard copy at the site information repositories at:
    USEPA Region 10 Records Center, 1200 Sixth Avenue, Suite 900,
Seattle, Washington, Monday through Friday, except Federal holidays,
between 8:00 a.m. and 5:00 p.m., Phone:<PHONE_NUMBER> or<PHONE_NUMBER>.
    City of Vancouver Water Resources Education Center, 4600 SE
Columbia Way, Vancouver, Washington, Monday through Friday, except
holidays, between 9 a.m. and 5 p.m. and Saturday between noon and 5:00
p.m., Phone:<PHONE_NUMBER>.

FOR FURTHER INFORMATION CONTACT: Jeremy Jennings, Remedial Project
Manager, U.S. Environmental Protection Agency, Region 10, ECL-122, 1200
Sixth Avenue, Suite 900, Seattle WA 98101,<PHONE_NUMBER>) email
[email protected].

SUPPLEMENTARY INFORMATION: The site to be deleted from the NPL is:
Vancouver Water Station #1 Superfund Site, Vancouver, Washington. A
Notice of Intent to Delete for this Site was published in the Federal
Register (82 FR 44548-44551) on September 25, 2017.
    The closing date for comments on the Notice of Intent To Delete was
October 25, 2017. One public comment was received. The comment was not
a site-specific adverse comment and EPA is proceeding with deletion. A
responsiveness summary was prepared and placed in both the docket, EPA-
HQ-SFUND-1994-0009, on www.regulations.gov, and in the site information
repositories listed above.
    EPA maintains the NPL as the list of sites that appear to present a
significant risk to public health, welfare, or the environment.
Deletion from the NPL does not preclude further remedial action.
Whenever there is a significant release from a site deleted from the
NPL, the deleted site may be restored to the NPL without application of
the hazard ranking system. Deletion of a site from the NPL does not
affect responsible party liability in the unlikely event that future
conditions warrant further actions.

List of Subjects in 40 CFR Part 300

    Environmental protection, Air pollution control, Chemicals,
Hazardous waste, Hazardous substances, Intergovernmental relations,
Penalties, Reporting and recordkeeping requirements, Superfund, Water
pollution control, Water supply.

    Dated: January 23, 2018.
Chris Hladick,
Regional Administrator--Region 10.

    For reasons set out in the preamble, 40 CFR part 300 is amended as
follows:

PART 300--NATIONAL OIL AND HAZARDOUS SUBSTANCES POLLUTION
CONTINGENCY PLAN

0
1. The authority citation for part 300 continues to read as follows:

    Authority:  33 U.S.C. 1321(d); 42 U.S.C. 9601-9657; E.O. 13626,
77 FR 56749, 3 CFR, 2013 Comp., p. 306; E.O. 12777, 56 FR 54757, 3
CFR, 1991 Comp., p. 351; E.O. 12580, 52 FR 2923, 3 CFR, 1987 Comp.,
p. 193.

Appendix B to Part 300--[Amended]

0
2. Table 1 of Appendix B to part 300 is amended by removing the entry
``WA'', ``Vancouver Water Station #1 Contamination'', ``Vancouver''.

[FR Doc. 2018-02353 Filed 2-5-18; 8:45 am]
 BILLING CODE 6560-50-P