[Federal Register Volume 85, Number 37 (Tuesday, February 25, 2020)]
[Notices]
[Pages 10809-10810]
[FR Doc No: 2020-03707]

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

DEPARTMENT OF TRANSPORTATION

Federal Motor Carrier Safety Administration

[Docket No. FMCSA-2006-25854; FMCSA-2013-0108; FMCSA-2014-0382; FMCSA-
2015-0115; FMCSA-2015-0116; FMCSA-2015-0119; FMCSA-2017-0252]

Qualification of Drivers; Exemption Applications; Epilepsy and
Seizure Disorders

AGENCY: Federal Motor Carrier Safety Administration (FMCSA), DOT.

ACTION: Notice of final disposition.

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

SUMMARY: FMCSA announces its decision to renew exemptions for 11
individuals from the requirement in the Federal Motor Carrier Safety
Regulations (FMCSRs) that interstate commercial motor vehicle (CMV)
drivers have ``no established medical history or clinical diagnosis of
epilepsy or any other condition which is likely to cause loss of
consciousness or any loss of ability to control a CMV.'' The exemptions
enable these individuals who have had one or more seizures and are
taking anti-seizure medication to continue to operate CMVs in
interstate commerce.

DATES: Each group of renewed exemptions were applicable on the dates
stated in the discussions below and will expire on the dates provided
below.

FOR FURTHER INFORMATION CONTACT: Ms. Christine A. Hydock, Chief,
Medical Programs Division,<PHONE_NUMBER><EMAIL_ADDRESS>FMCSA,
Department of Transportation, 1200 New Jersey Avenue SE, Room W64-224,
Washington, DC 20590-0001. Office hours are from 8:30 a.m. to 5 p.m.,
ET, Monday through Friday, except Federal holidays. If you have
questions regarding viewing or submitting material to the docket,
contact Docket Operations,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Public Participation

A. Viewing Documents and Comments

    To view comments, as well as any documents mentioned in this notice
as being available in the docket, go to http://www.regulations.gov.
Insert the docket number, FMCSA-2006-25854; FMCSA-2013-0108; FMCSA-
2014-0382; FMCSA-2015-0115; FMCSA-2015-0116; FMCSA-2015-0119; FMCSA-
2017-0252, in the keyword box, and click ``Search.'' Next, click the
``Open Docket Folder'' button and choose the document to review. If you
do not have access to the internet, you

may view the docket online by visiting Docket Operations in Room W12-
140 on the ground floor of the DOT West Building, 1200 New Jersey
Avenue SE, Washington, DC 20590, between 9 a.m. and 5 p.m., ET, Monday
through Friday, except Federal holidays.

B. Privacy Act

    In accordance with 5 U.S.C. 553(c), DOT solicits comments from the
public to better inform its rulemaking process. DOT posts these
comments, without edit, including any personal information the
commenter provides, to www.regulations.gov, as described in the system
of records notice (DOT/ALL-14 FDMS), which can be reviewed at
www.transportation.gov/privacy.

II. Background

    On December 30, 2019, FMCSA published a notice announcing its
decision to renew exemptions for 11 individuals from the epilepsy and
seizure disorders prohibition in 49 CFR 391.41(b)(8) to operate a CMV
in interstate commerce and requested comments from the public (84 FR
72112). The public comment period ended on January 29, 2020, and one
comment was received.
    FMCSA has evaluated the eligibility of these applicants and
determined that renewing these exemptions would achieve a level of
safety equivalent to, or greater than, the level that would be achieved
by complying with Sec.  391.41(b)(8).
    The physical qualification standard for drivers regarding epilepsy
found in Sec.  391.41(b)(8) states that a person is physically
qualified to drive a CMV if that person has no established medical
history or clinical diagnosis of epilepsy or any other condition which
is likely to cause the loss of consciousness or any loss of ability to
control a CMV.
    In addition to the regulations, FMCSA has published advisory
criteria \1\ to assist medical examiners in determining whether drivers
with certain medical conditions are qualified to operate a CMV in
interstate commerce.
---------------------------------------------------------------------------

    \1\ These criteria may be found in APPENDIX A TO PART 391--
MEDICAL ADVISORY CRITERIA, section H. Epilepsy: Sec.  391.41(b)(8),
paragraphs 3, 4, and 5, which is available on the internet at
https://www.gpo.gov/fdsys/pkg/CFR-2015-title49-vol5/pdf/CFR-2015-title49-vol5-part391-appA.pdf.
---------------------------------------------------------------------------

III. Discussion of Comments

    FMCSA received one comment in this proceeding. This comment
supported granting these exemptions.

IV. Conclusion

    Based on its evaluation of the 11 renewal exemption applications
and comment received, FMCSA announces its decision to exempt the
following drivers from the epilepsy and seizure disorders prohibition
in Sec.  391.41(b)(8).
    In accordance with 49 U.S.C. 31136(e) and 31315(b), the following
groups of drivers received renewed exemptions in the month of December
and are discussed below.
    As of December 16, 2019, and in accordance with 49 U.S.C. 31136(e)
and 31315(b), the following five individuals have satisfied the renewal
conditions for obtaining an exemption from the epilepsy and seizure
disorders prohibition in the FMCSRs for interstate CMV drivers (84 FR
72112):

William Brown (NC)
Robert J. Forney (WI)
Curtis Alan Hartman (MD)
Wendell F. Headley (MO)
Marion Legg (MD)

    The drivers were included in docket numbers FMCSA-2015-0115, FMCSA-
2015-0116, and FMCSA-2015-0119. Their exemptions are applicable as of
December 16, 2019, and will expire on December 16, 2021.
    As of December 23, 2019, and in accordance with 49 U.S.C. 31136(e)
and 31315(b), the following five individuals have satisfied the renewal
conditions for obtaining an exemption from the epilepsy and seizure
disorders prohibition in the FMCSRs for interstate CMV drivers (84 FR
72112):

Gary Freeman (WI)
Aaron Gillette (SD)
David Kestner (VA)
Chad Smith (MA)
Trever Williams (MN)

    The drivers were included in docket number FMCSA-2006-25854, FMCSA-
2013-0108, and FMCSA-2014-0382. Their exemptions are applicable as of
December 23, 2019, and will expire on December 23, 2021.
    As of December 28, 2019, and in accordance with 49 U.S.C. 31136(e)
and 31315(b), the following individual has satisfied the renewal
conditions for obtaining an exemption from the epilepsy and seizure
disorders prohibition in the FMCSRs for interstate CMV driver (84 FR
72112): David Pamperin (WI).
    This driver was included in docket number FMCSA-2017-0252. His
exemption is applicable as of December 28, 2019, and will expire on
December 28, 2021.
    In accordance with 49 U.S.C. 31315(b), each exemption will be valid
for 2 years from the effective date unless revoked earlier by FMCSA.
The exemption will be revoked if the following occurs: (1) The person
fails to comply with the terms and conditions of the exemption; (2) the
exemption has resulted in a lower level of safety than was maintained
prior to being granted; or (3) continuation of the exemption would not
be consistent with the goals and objectives of 49 U.S.C. 31136(e) and
31315(b).

    Issued on: February 12, 2020.
Larry W. Minor,
Associate Administrator for Policy.
[FR Doc. 2020-03707 Filed 2-24-20; 8:45 am]
 BILLING CODE 4910-EX-P


[Federal Register: September 30, 2005 (Volume 70, Number 189)]
[Notices]
[Page 57336]
[DOCID:fr30se05-156]

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

SECURITIES AND EXCHANGE COMMISSION

Sunshine Act Meeting

    Notice is hereby given, pursuant to the provisions of the
Government in the Sunshine Act, Public Law 94-409, that the Securities
and Exchange Commission will hold the following meetings during the
week of October 3, 2005:
    A Closed Meeting will be held on Thursday, October 6, 2005 at 2:30
p.m.
    Commissioners, Counsel to the Commissioners, the Secretary to the
Commission, and recording secretaries will attend the Closed Meeting.
Certain staff members who have an interest in the matters may also be
present.
    The General Counsel of the Commission, or his designee, has
certified that, in his opinion, one or more of the exemptions set forth
in 5 U.S.C. 552b(c)(5), (7), (9)(B), and (10) and 17 CFR 200.402(a)(5),
(7), 9(ii) and (10) permit consideration of the scheduled matters at
the Closed Meeting.
    Commissioner Campos, as duty officer, voted to consider the items
listed for the closed meeting in closed session.
    The subject matters of the Closed Meeting scheduled for Thursday,
October 6, 2005 will be:

Formal orders of private investigations;
Institution and settlement of injunctive actions;
Institution and settlement of administrative proceedings of an
enforcement nature; and
Adjudicatory matters.

    At times, changes in Commission priorities require alterations in
the scheduling of meeting items.
    For further information and to ascertain what, if any, matters have
been added, deleted or postponed, please contact:
    The Office of the Secretary at<PHONE_NUMBER>.

    Dated: September 27, 2005.
Jonathan G. Katz,
Secretary.
[FR Doc. 05-19698 Filed 9-28-05; 11:40 am]

BILLING CODE 8010-01-P


[Federal Register Volume 76, Number 221 (Wednesday, November 16, 2011)]
[Notices]
[Pages 71116-71117]
[FR Doc No: 2011-29605]

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

DEPARTMENT OF TRANSPORTATION

Federal Railroad Administration

[Docket No. FRA 2011-001-N-16]

Proposed Agency Information Collection Activities; Comment
Request

AGENCY: Federal Railroad Administration, DOT.

ACTION: Notice.

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

SUMMARY: In accordance with the Paperwork Reduction Act of 1995 and its
implementing regulations, the Federal Railroad Administration (FRA)
hereby announces that it is seeking renewal of the following currently
approved information collection activities. Before submitting these
information collection requirements for clearance by the Office of
Management and Budget (OMB), FRA is soliciting public comment on
specific aspects of the activities identified below.

DATES: Comments must be received no later than January 17, 2012.

ADDRESSES: Submit written comments on any or all of the following
proposed activities by mail to either: Ms. Janet Wylie, Office of
Planning and Administration, RPD-3, Federal Railroad Administration,
1200 New Jersey Ave. SE., Mail Stop 20, Washington, DC 20590, or Ms.
Kimberly Toone, Office of Information Technology, RAD-20, Federal
Railroad Administration, 1200 New Jersey Ave. SE., Mail Stop 35,
Washington, DC 20590. Commenters requesting FRA to acknowledge receipt
of their respective comments must include a self-addressed stamped
postcard stating, ``Comments on OMB control number 2130-0548.''
Alternatively, comments may be transmitted via facsimile to (202) 493-
6170, or via email to Mr. Wylie at<EMAIL_ADDRESS>or to Ms. Toone
at<EMAIL_ADDRESS>Please refer to the assigned OMB control number
in any correspondence submitted. FRA will summarize comments received
in response to this notice in a subsequent notice and include them in
its information collection submission to OMB for approval.

FOR FURTHER INFORMATION CONTACT: Ms. Janet Wylie, Office of Planning
and Administration, RPD-3, Federal Railroad Administration, 1200 New
Jersey Ave, SE., Mail Stop 20, Washington, DC 20590 (telephone: (202)
493-6353) or Ms. Kimberly Toone, Office of Information Technology, RAD-
20, Federal Railroad Administration, 1200 New Jersey Ave. SE., Mail
Stop 35, Washington, DC 20590 (telephone:<PHONE_NUMBER>). (These
telephone numbers are not toll-free.)

SUPPLEMENTARY INFORMATION: The Paperwork Reduction Act of 1995 (PRA),
Public Law 104-13, Sec.  2, 109 Stat. 163 (1995) (codified as revised
at 44 U.S.C. 3501-3520), and its implementing regulations, 5 CFR part
1320, require Federal agencies to provide 60-days notice to the public
for comment on information collection activities before seeking
approval for reinstatement or renewal by OMB. 44 U.S.C. 3506(c)(2)(A);
5 CFR 1320.8(d)(1), 1320.10(e)(1), 1320.12(a). Specifically, FRA
invites interested respondents to comment on the following summary of
proposed information collection activities regarding (i) Whether the
information collection activities are necessary for FRA to properly
execute its functions, including whether the activities will have
practical utility; (ii) the accuracy of FRA's estimates of the burden
of the information collection activities, including the validity of the
methodology and assumptions used to determine the estimates; (iii) ways
for FRA to enhance the quality, utility, and clarity of the information
being collected; and (iv) ways for FRA to minimize the burden of
information collection activities on the public by automated,
electronic, mechanical, or other technological collection techniques or
other forms of information technology (e.g., permitting electronic
submission of responses). See 44 U.S.C. 3506(c)(2)(A)(I)-(iv); 5 CFR
1320.8(d)(1)(I)-(iv). FRA believes that soliciting public comment will
promote its efforts to reduce the administrative and paperwork burdens
associated with the collection of information mandated by Federal
regulations. In summary, FRA reasons that comments received will
advance three objectives: (i) Reduce reporting burdens; (ii) ensure
that it organizes information collection requirements in a ``user
friendly'' format to improve the use of such information; and (iii)
accurately assess the resources expended to retrieve and produce
information requested. See 44 U.S.C. 3501.
    Below is a brief summary of the information collection activities
that FRA will submit for clearance by OMB as required under the PRA:
    Title: Railroad Rehabilitation and Improvement Financing Program.
    OMB Control Number: 2130-0548.
    Status: Regular Review.
    Type of Request: Extension without change of a previously approved
collection.
    Abstract: Title V of the Railroad Revitalization and Regulatory
Reform Act of 1976 (Act), 45 U.S.C. 821 et seq., authorized the Federal
Railroad Administration (FRA) to provide railroads financial assistance
through the purchase of preference shares, and the issuance of loan
guarantees. Section 7203 of the Transportation Equity Act for the 21st
Century of 1998, Public Law 105-178 (1998) (TEA 21), and subsequent
amendments in the Safe, Accountable, Flexible, Efficient Transportation
Equity Act: A Legacy for Users, Public Law 109-59 (2005) SAFETEA-LU and
the Rail Safety Improvement Act of 2008 (RSIA), Division A of Public
Law 110-432 have since replaced the previous Title V financing program.
On July 6, 2000, FRA published a final rule (FR) with procedures and
requirements to cover applications of financial assistance in the form
of direct loans and loan guarantees consistent with the changes made to
Title V of the Act by section 7203 of TEA 21. On September 29, 2010,
FRA published a Notice Regarding Consideration and Processing of
Applications for Financial Assistance Under the Railroad Rehabilitation
and Improvement Financing (RRIF) Program. The collection of information
is used by FRA staff to determine the legal and financial eligibility
of applicants for direct loans regarding eligible projects. Eligible
projects include: (1) Acquisition, improvement or rehabilitation of
intermodal or rail equipment or facilities (including tracks,
components of tracks, bridges, yards, buildings, and shops); (2)
Refinancing outstanding debt incurred for these purposes; or (3)
Development or establishment of new intermodal or

railroad facilities. The aggregate unpaid principal amounts of
obligations cannot exceed $35.0 billion at any one time, and not less
than $7.0 billion is to be available solely for projects benefitting
freight railroads other than Class I carriers. The Secretary of
Transportation has delegated his authority under the RRIF Program to
the FRA Administrator in 1 CFR 1.49.
    Affected Public: State and local governments, government sponsored
authorities and corporations, railroads, and joint ventures that
include at least one railroad.

                                                Reporting Burden
----------------------------------------------------------------------------------------------------------------
                                                                                Average time
            CFR section              Respondent universe        Total annual       per response    Total annual
                                                                 responses            (hours)      burden hours
----------------------------------------------------------------------------------------------------------------
260.23--Form and Content of         75,635 potential       18 applications......              20             360
 Application.                        applicants.
260.25--Additional Information      650 potential........  15 financial                       50             750
 Loan Guarantees.                                           documents.
260.31--Execution and Filing of     75,635 potential.....  18 executed app......              .6            10.8
 Application.
Certificates with Original          75,635 potential.....  18 certificates......              .6            10.8
 Application.
Transmittal Letters...............  75,635 potential.....  18 letters...........              .6            10.8
Application Packages..............  75,635 potential.....  18 packages..........             1.5              27
260.33--Information Statements....  75,635 potential.....  18 statements........             *30               9
260.35--Environmental Impact        75,635 potential.....  1 Impact Statement...          15,552          15,552
 Statement.
Environmental Assessment..........  75,635 potential.....  2 Assessments........           4,992           9,984
Categorical Exclusions............  75,635 potential.....  15 exclusions........             176           2,640
Environmental Consultations.......  75,635 potential.....  5 consultations......               1               5
260.41--Inspection and Reporting--  75,635 potential.....  18 financial records.              10             180
 Financial Records and Other
 Documents.
----------------------------------------------------------------------------------------------------------------
* In minutes.

    Total Responses: 164.
    Estimated Total Annual Burden: 29,539.4.
    Pursuant to 44 U.S.C. 3507(a) and 5 CFR 1320.5(b),
1320.8(b)(3)(vi), FRA informs all interested parties that it may not
conduct or sponsor, and a respondent is not required to respond to, a
collection of information unless it displays a currently valid OMB
control number.

    Authority: 44 U.S.C. 3501-3520.

    Issued in Washington, DC, on November 9, 2011.
Kimberly Coronel,
Director, Office of Financial Management, Federal Railroad
Administration.
[FR Doc. 2011-29605 Filed 11-15-11; 8:45 am]
BILLING CODE 4910-06-P


 UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
			WASHINGTON, D.C.  20460

							OFFICE OF CHEMICAL SAFETY 								AND POLLUTION PREVENTION

MEMORANDUM

DATE:		June 3, 2020

SUBJECT:      IN-11325; Magnesium Sulfate Anhydrous and Hydrated Forms: Human Health
      Risk and Ecological Effects Assessment of a Food Use Pesticide Inert Ingredient

            CAS Reg. Nos.: 7487-88-9, 14168-73-1, 15320-30-6, 24378-31-2, 15553-21-6,
                           17830-18-1, 10034-99-8
                  PC Code:  850503
                  Decision:  551826

FROM:	Deirdre Sunderland, MHS, Industrial Hygienist
		Chemistry, Inerts & Toxicology Assessment Branch (CITAB)
		Registration Division (RD)

TO:		Kerry B. Leifer, Branch Chief
		CITAB/RD

 EXECUTIVE SUMMARY

In June 2019, Ecolab, Inc. submitted a petition (IN-11325) to the Environmental Protection Agency (herein referred to as EPA or the Agency) requesting exemptions from the requirement of a tolerance for residues of magnesium sulfate anhydrous (CAS Reg. No. 7487-88-9) and its hydrated forms: magnesium sulfate monohydrate (CAS Reg. No. 14168-73-1); magnesium sulfate trihydrate (CAS Reg. No. 15320-30-6); magnesium sulfate tetrahydrate (CAS Reg. No. 24378- 31-2); magnesium sulfate pentahydrate (CAS Reg. No. 15553-21-6); magnesium sulfate hexahydrate (CAS Reg. No. 17830-18-1); and magnesium sulfate heptahydrate (CAS Reg. No. 10034-99-8), when used as an inert ingredient in antimicrobial pesticide formulations applied to food-contact surfaces in public eating places, dairy-processing equipment, and food-processing equipment and utensils under 40 CFR § 180.940(a) at a maximum end-use concentration of 4400 parts per million (ppm). For ease of reading, this group of chemicals will be referred to as magnesium sulfate throughout the document.

Magnesium sulfate is ubiquitous in the environment and is currently approved for use as a food use inert ingredient (solid diluent, carrier, safener) in pesticide products under 40 CFR § 180.910 for use pre- and post-harvest. It is also used in various other non-pesticidal food and consumer products, including pharmaceuticals, dietary supplements, fertilizers, cosmetics, and as a food and beverage additive. One form, magnesium sulfate heptahydrate, also known as Epsom salt, has been used for centuries as an over the counter laxative and a soaking agent for aching joints.

Because of its omnipresence and high use pattern, magnesium sulfate has been the subject of various peer-reviewed assessments (e.g., Cosmetic Ingredient Review (CIR), and Organization for Economic Cooperation and Development (OECD)) which are utilized in this risk assessment to aid in making a safety determination for magnesium sulfate. Available acute studies on magnesium sulfate include an oral toxicity study, a dermal irritation study, and a dermal sensitization study. Repeat dose toxicity testing for magnesium sulfate includes an OECD Test Guideline 422: Combined Repeat Dose Reproduction/Developmental Toxicity Screening Test and a 1-year inhalation cancer study in rats. Magnesium sulfate was also tested for genotoxic and/or mutagenic effects using a bacterial reverse mutation test and an in vitro mammalian chromosome aberration test.

All studies showed low acute and repeat dose toxicity and no reproductive/developmental toxicity. The primary health effect associated with magnesium sulfate is an osmotic laxative effect at high doses. The laxative effect is transient, and recovery is rapid and is usually observed only when following acute exposures to high concentrations (e.g., pharmacological uses).

The OECD Test Guideline 422 study showed no adverse effect at the No Observed Adverse Effect Level (NOAEL) of 450 mg/kg/day, the highest dose tested. In addition, there was no evidence of carcinogenicity or neuropathological changes or effects reported in any of the studies. The Agency therefore does not believe magnesium sulfate is carcinogenic or neurotoxic.

Magnesium sulfate is currently approved for use under 40 CFR §180.910 and a review of currently approved pesticide products containing magnesium sulfate found that the majority of products were lawn care products and products used in swimming pools. Ecolab, Inc. is requesting that EPA establish an exemption from the requirement of a tolerance for magnesium sulfate for use in antimicrobial pesticide formulations applied to food-contact surfaces in public eating places, dairy-processing equipment, and food-processing equipment and utensils at a maximum concentration of 4400 ppm. Based on the current and proposed use patterns of magnesium sulfate, dietary and residential exposure from pesticidal uses are expected. However, no toxicological endpoint of concern was identified in the database; therefore, a quantitative risk assessment was not necessary. As part of its qualitative assessment, the Agency did not use safety factors for assessing risk, and no additional safety factor is needed for assessing risk to infants and children.

Magnesium sulfate is found naturally in water, and based on various aquatic studies, it does not present a hazard for aquatic systems or the environment. Overall, the widespread use of magnesium sulfate in foods, drugs, and cosmetics, in combination with the natural occurrence of both magnesium and sulfate in the body, indicate that this compound does not pose a safety risk from these uses.

Based upon the factors summarized above, the Agency has determined that there is a reasonable certainty that no harm to the general population or any population subgroup, including infants and children, will result from aggregate exposure to magnesium sulfate residues. Therefore, the Agency is establishing exemptions from the requirement of a tolerance for residues of magnesium sulfate under 40 CFR § 180.940(a) when used as an inert ingredient in antimicrobial pesticide formulations applied to food-contact surfaces in public eating places, dairy-processing equipment, and food-processing equipment and utensils at a maximum end-use concentration of 4400 ppm.

 BACKGROUND

In June 2019 Ecolab, Inc. submitted a petition (IN-11325) to the Environmental Protection Agency (herein referred to as EPA or the Agency) requesting an exemption from the requirement of tolerance for magnesium sulfate anhydrous (CAS Reg. No. 7487-88-9) and its hydrated forms: magnesium sulfate monohydrate (CAS Reg. No. 14168-73-1); magnesium sulfate trihydrate (CAS Reg. No. 15320-30-6); magnesium sulfate tetrahydrate (CAS Reg. No. 24378- 31-2); magnesium sulfate pentahydrate (CAS Reg. No. 15553-21-6); magnesium sulfate hexahydrate (CAS Reg. No. 17830-18-1); and magnesium sulfate heptahydrate (CAS Reg. No. 10034-99-8) as inert ingredients in pesticide formulations under 40 CFR § 180.940 (a) at a maximum of concentration of 4400 parts per million (ppm) when used in antimicrobial formulations applied to food-contact surfaces in public eating places, dairy processing equipment, food-processing equipment and utensils. For ease of reading this group of chemicals will be referred to as magnesium sulfate throughout the document. Magnesium sulfate is currently approved for use as a food use inert ingredient (solid diluent, carrier, safener) in pesticide products under 40 CFR § 180.910 for use pre- and post-harvest.

In addition to its natural abundance in the enviroment, magnesium sulfate is broadly used in pharmaceuticals, foods and beverages, dietary supplement, fertilizers, and cosmetics. Magnesium sulfate is used in both human and animal pharmaceutical products for its effect as an analgesic, anesthetic, anti-arrhythmia agent, anticonvulsant, calcium channel blocker, cathartic, tocolytic agent, bronchodilator, electrolyte replacement aid, laxative, and treatment of cardiac arrhythmias and malignant hypothermia. It is commonly administered by injection or intravenously for the prevention and control of seizures in preeclampsia and eclampsia in pregnant women. Magnesium sulfate heptahydrate, known as Epsom salt, is an over-the-counter (OTC) drug and cosmetic ingredient. It is commonly dissolved in bathwater as an analgesic soaking agent. As a cosmetic, it is used at concentrations up to 11% and 25% in leave-on and rinse-off products, respectively (MRID 50871303).

In 2007, the Food and Agricultural Organization of the United Nations (FAO) and the World Health Organization (WHO) Joint Expert Committee on Food Additives (JECFA) concluded that the Acceptable Daily Intake (ADI) of magnesium sulfate was "not specified":

	Taking into consideration 1) the widespread occurrence of magnesium and
      sulfate in the food supply from natural sources and use of other magnesium
      salts as additives, 2) the uses of magnesium sulfate as a flavour enhancer,
      firming agent, fermentation aid and nutrient and 3) the previous guidance of
      the Committee regarding various cation and anion combinations, the Committee
      allocated an ADI "not specified" for magnesium sulfate.  (MRID 50871309)

Magnesium and sulfate are ubiquitous in the earth's crust representing the 8[th] and 14[th] most abundant elements, respectively. Both magnesium and sulfate are essential for the human body.

 PHYSICAL/CHEMICAL PROPERTIES

Below are the available physical and chemical properties for magnesium sulfate. Table 1 list the anhydrous and hydrated forms of magnesium sulfate supported by this petition. Table 2 outlines some of the physical/chemical characteristics of magnesium sulfate anhydrous.

           Table 1: Chemical Identity of Magnesium Sulfate Compounds
Chemical Name
Chemical Formula
CAS Reg. No.
Molecular Weight
Magnesium sulfate anhydrous
MgSO4
7487-88-9
120. 37
Magnesium sulfate monohydrate
MgSO4·H2O
14168-73-1
138.38
Magnesium sulfate trihydrate
MgSO4·3H2O
15320-30-6
174.41
Magnesium sulfate tetrahydrate
MgSO4·4H2O
24378-31-2
192.42
Magnesium sulfate pentahydrate
MgSO4·5H2O
5553-21-6
219.44
Magnesium sulfate hexahydrate
MgSO4·6H2O
7830-18-1
228.46
Magnesium sulfate heptahydrate
MgSO4·7H2O
10034-99-8
246.47

Magnesium sulfate is freely soluble in water and will dissociate into magnesium and sulfate ions. Magnesium (Mg[2+]) is likely to form complexes with ligands like organic matter. Sulfate (SO4[2-]) may reduce under anaerobic conditions to sulfide ion, which in turn will reach an equilibrium with hydrogen sulfide. Indices of environmental fate such as log Kow, log Koc, biodegradation and photolysis do not apply to inorganic substances like magnesium sulfate.

     Table 2: Physical/Chemical Properties of Magnesium Sulfate Anhydrous
Characteristic
Value
Source
Structure

MRID 50871314
Appearance
White crystalline powder or needle-like colorless crystals
MRID 50871314
Density (g/cm[3])
 2.66
MRID 50871314
Melting point
1124 °C
MRID 50871314
Water Solubility (g/L)
357 at 25˚C
MRID 50871314

Based on the solubility of magnesium sulfate in water the anhydrous and hydrated forms would be indistinguishable in the environment.

 METABOLISM

Magnesium sulfate dissociates into magnesium and sulfate ions in the gastrointestinal tract after reaction with gastric acids. Magnesium is a macronutrient and serves vital functions in the human body. It is ubiquitous in the environment and all living things. According to the National Institutes of Health (MRID 50871311), "magnesium is a cofactor for over 300 metabolic enzyme systems that regulate diverse biochemical reactions in the body including protein synthesis, muscle and nerve function, blood glucose control, and blood pressure regulation. It is required for energy production, oxidative phosphorylation, and glycolysis, contributes to the structural development of bone, and is also required for the synthesis of DNA, RNA, and the antioxidant glutathione. "Magnesium also plays a role in the active transport of calcium and potassium ions across cell membranes, a process that is important to nerve impulse conduction, muscle contraction, and normal heart rhythm."

Magnesium is absorbed primarily in the small intestine. Most magnesium in the body is found inside cells or in bone; however, some magnesium is present in every cell of the body. In blood plasma, about 65 percent is the ionic form while the remainder is bound to protein. The balance in the body is regulated by intestinal absorption, exchange with bone, and renal excretion (MRID 50871317). Urine is the major route of excretion under normal conditions, although excretion through sweat and milk is also possible (MRID 50871314). Magnesium is filtered by the glomeruli and reabsorbed by renal tubules. Unabsorbed magnesium is excreted primarily in the feces.

Sulfates are naturally occurring abundant substances that are found in minerals, soil, and rocks. They are present in ambient air, groundwater, plants, and food. Sulfate is also an important macronutrient, necessary for the normal function of cells. Sulfate absorption is determined by the dose and the accompanying anion, with magnesium being poorly absorbed in general. It is the fourth most abundant anion in human plasma (300 μM) (MRID 50871321) and all cells have sulfate transporters for the influx/efflux of sulfate.

According to the 2005 US Institutes of Medicine "Dietary Reference Intakes for Water, Potassium, Sodium, Chloride, and Sulfate (MRID 50871307)":

      Inorganic sulfate (SO4[2−]) is required for the synthesis of 3′-phosphoadenosine-5′-phosphosulfate (PAPS). PAPS is required for synthesis of many important sulfur-containing compounds, such as chondroitin sulfate and cerebroside sulfate. While significant levels of sulfate are found in foods and various sources of drinking water, the major source of inorganic sulfate for humans is from biodegradation due to body protein turnover of the sulfur amino acids methionine and cysteine. Dietary sulfate in food and water, together with sulfate derived from methionine and cysteine found in dietary protein and the cysteine component of glutathione, provides sulfate for use in PAPS biosynthesis. Sulfate requirements are thus met when intakes include recommended levels of sulfur amino acids. For this reason, neither an Estimated Average Requirement (and thus a Recommended Dietary Allowance) nor an Adequate Intake for sulfate is established.

Sulfate is absorbed from the intestine by an active transport system. Low doses of sulfate are generally absorbed well while high doses, such as those used medicinally to soften stool, probably exceed absorptive capacity, so that much of the dose is excreted in the feces. Sulfate is also used for detoxification of compounds to sulfate esters, which can be excreted in the urine. Sulfate is eliminated by the kidney, and levels are regulated by the kidney through a reabsorption mechanism. (MRID 50871321).

 TOXICOLOGY

Available toxicity data for magnesium sulfate are summarized below. The primary adverse health effect associated with magnesium sulfate is an osmotic laxative effect at high doses. The laxative effect is transient, and recovery is rapid and is usually only observed when following acute exposures to relatively high concentrations (e.g., pharmacological uses).

 Acute Toxicity

Data on acute toxicity, as well as data on eye and skin irritation and skin sensitization, are discussed in this section.

 Acute Oral Toxicity
An acute oral toxicity study (Organization for Economic Cooperation and Development (OECD) Test Guideline 423) on magnesium sulfate anhydrous was performed with female Sprague-Dawley rats (MRID 50871314). Magnesium sulfate was administered at 300 and 2,000 mg/kg via gavage and animals (6/dose) were observed for 14 days. Clinical signs of toxicity were recorded at 30 minutes, 1, 2, 3, 4 and 8 hours after administration, then once per day until the end of testing. No deaths were observed, and bodyweights increased normally. At the high dose, diarrhea and watery diarrhea were present for the first 8 hours. No clinical signs of toxicity were noted at 300 mg/kg. No reduction in body weight or macroscopic abnormalities were noted at either dose. The oral median lethal dose (LD50) value was determined to be >2,000 mg/kg for female rats.
 Acute Dermal Toxicity
No acute dermal toxicity studies were available for magnesium sulfate; however, magnesium sulfate heptahydrate (i.e., Epsom salts) has a long history of over the counter use as an analgesic via full body soaking which would indicate that this compound is not likely to be toxic via the dermal route.

 Acute Inhalation Toxicity

No acute inhalation toxicity studies are available for magnesium sulfate.
 Skin Irritation
A preliminary skin irritation study (MRID 50871303) was performed in mice prior to a skin sensitization study described in Section 5.1.6. A 50% solution of anhydrous magnesium sulfate was applied to the ears of two animals on three consecutive days. Observations were recorded at approximately 3-4 hours after the last application. No skin irritation or macroscopic abnormalities were observed in any of the animals.
 Eye Irritation
There are no eye irritation studies available for magnesium sulfate. However, the widespread use of magnesium sulfate in foods, drugs, and cosmetics, in combination with the natural occurrence of both magnesium and sulfate in the body, indicate that this compound is unlikely to have strongly irritating or sensitizing properties.
 Skin Sensitization
Magnesium sulfate anhydrous was evaluated using an OECD Test Guideline 429 mouse local lymph node assay (MRID 50871303). According to the Cosmetic Ingredient Review (CIR) Expert Panel which reviewed the study, the dorsal surface of both ears of 5 mice/dose were treated with magnesium sulfate at concentrations of 10%, 25%, and 50% plus a vehicle control, using a dose volume of 25 μL/ear. Mice were then injected intravenously with 3H-methyl thymidine, sacrificed, and lymph nodes collected. The stimulation index (SI) was calculated for each group. Magnesium sulfate did not elicit an SI of >= 3 at any concentration tested; therefore, it was considered a non-sensitizer.

 Repeat Dose Toxicity

 Combined Repeated Dose Range-Finding Toxicity Study (Oral Toxicity Study in Rats)

An OECD Test Guideline 422: Combined Repeat Dose Reproduction/Developmental Toxicity Screening Test was carried out on magnesium sulfate anhydrous and the results were reported and reviewed in the OECD Screening Information Dataset (SIDS) for magnesium sulfate (MRID 50871314). Male and female Sprague Dawley rats (13/sex/dose) received 0, 50, 150 or 450 mg/kg/day magnesium sulfate in water. An additional 6 animals (3/sex) per group were used in a 2-week recovery group and dosed at 0 or 450 mg/kg/day.

Males of the main group and both sexes of the recovery group were dosed two weeks each prior to, during and post mating. Females of the main group were dosed two weeks prior to mating, throughout gestation and for 5-6 days after delivery until the day of sacrifice.

According to the OECD SIDS assessment:

      All animal were observed for mortality, general condition and gross evidence of clinical signs and symptoms daily throughout the study. Individual body weights of both sexes were measured once a week
      throughout the dosing period. Food consumption was recorded. Sensory function and motor activity,
      urinalysis, hematology, blood chemistry, organ weights and histopathology were examined. In the
      main and recovery groups, there were no mortalities during the study. No abnormalities in clinical
      signs were observed in 50 and 150 mg/kg main groups. However, soft stool was sporadically or
      frequently observed in most animals in 450 mg/kg main group, and it was recovered in all animals
      of both sexes in recovery period. No dose-related changes in detailed clinical observations such as
      detailed physical examinations for signs and symptoms of adverse effects, including central and
      autonomic nervous system effects, motor activity and behavior, body weights and food
      consumption were noted. In addition, no dose-related changes in sensory function, motor activity,
      urinalysis, hematology, blood chemistry and organ weights were noted. No effects were evident at
      necropsy and histopathology.

In both sexes of 150 mg/kg group, soft stool was observed 1-2 times in 1-3 animals. This was noted by OECD to be "no effect of toxicity." The occurrence of soft stool increased in the high dose group and was either sporadically or frequently observed in 10-11 animals of both sexes; this effect was considered dose related. Soft stool did not last after the first day of the recovery period. One female had stomach ulcers and hyperplasia; however, no other animals showed evidence of stomach histopathology. In the absence of other adverse effects of treatment, the Agency does not consider soft stool alone to be an adverse effect of treatment and therefore considers the NOAEL to be 450 mg/kg/day. A Lowest Observed Adverse Effect Level (LOAEL) could not be determined.

 Reproductive and Developmental Toxicity
As noted in the section 5.2 above "Repeated Dose Toxicity," an OECD Test Guideline 422: Combined Repeat Dose Reproduction/Developmental Toxicity Screening Test was carried out for magnesium sulfate anhydrous (MRID 50871314). Male and female Sprague Dawley rats (13/sex/dose) received 0, 50, 150 or 450 mg/kg/day magnesium sulfate anhydrate in water and an additional 6 animals per group were used in a 2-week recovery group. Males of the main group and both sexes of the recovery group were dosed two weeks each prior to, during, and post mating. Females of the main group were dosed two weeks prior to mating, throughout gestation, and for 5-6 days after delivery until the day of sacrifice. In addition to the endpoints noted in section 5.2.1 above, the following parameters were examined in F1 offspring: number and sex of pups, number of corpora lutea and uterine implants, mean litter size, live births, postnatal mortality, body weights of pups on postnatal day (PND) 0 and 4, and external examination of all pups on delivery day and on PND 4.

No significant dose-related effects were observed on reproductive function or development. The gestation indices were 100% and the pre-implantation loss rates were 10.5% and 4.8% in the control and 450 mg/kg/day groups, respectively. The post-implantation loss rates and the live birth indices were not affected nor were viability indices on postnatal day 0 and 4. Furthermore, no effects were noted in live birth index, sex ratio, mean litter size, and external findings including eye, ear, mouth, palate, absence of limbs and tail, position, size and shape on PND 0 and 4. Finally, as noted above, there were no significant changes in weight or histopathological findings in testes, epididymides, ovaries, or uterus. The NOAEL for reproductive and developmental effects was the highest dose tested, 450 mg/kg/day. A LOAEL could not be determined.
 Genotoxicity and Mutagenicity

 Bacterial Reverse Mutation Test

A reverse mutation assay was carried out with magnesium sulfate at concentrations of up to 100 mg/plate (MRID 50841308). Magnesium sulfate did not induce an increase in the frequency of revertant colonies in Salmonella typhimurium strains TA92, TA1535, TA100, TA1537, TA94 and TA98 with or without metabolic activation from S9 mix.

In a second study outlined in the SIDS report on magnesium sulfate (MRID 50871314), an OECD Test Guideline 471 bacterial reverse mutation assay was performed with S. typhimurium strains TA 1535, TA 1537, TA 98, and TA 100 and Escherichia coli WP2uvrA in the presence and absence of metabolic activation (S9 mix). The plate incorporation method was used employing three replicates at each dose level. Based on preliminary test results, magnesium sulfate doses ranged from 156.3 to 5,000 ug/plate by a factor of two. The test substance did not induce an increase in the frequency of revertant colonies in a dose-dependent manner under any condition tested. Based on the results, magnesium sulfate was not considered to be genotoxic under the test conditions.
 In Vitro Mammalian Chromosome Aberration Test

An in vitro chromosomal aberration test was performed on magnesium sulfate using a Chinese hamster fibroblast cell line. Cells were exposed to three different doses for 24 and 48 hours in the absence of metabolic activation. The maximum dose was 4 mg/mL and was selected in a preliminary test that determined the dose needed for 50% cell-growth inhibition. No polyploid cells or cells with structural aberrations were observed at any dose. The results of this study indicate that magnesium sulfate was not clastogenic under these conditions (MRID 50841308).

In a second study outlined in the SIDS report on magnesium sulfate (MRID 50871314), an OECD Test Guideline 473 in vitro mammalian chromosome aberration test using Chinese Hamster Lung (CHL) cells was performed both in the absence and the presence of metabolic activation system (S9 mix). Cells were treated with 1000, 2000, or 5000 ug/mL for 6 hours followed by 18 hours of recovery period. There was no significant increase in the number of structural aberrations or numerical aberrations compared to controls at any dose level with and without metabolic activation. These results indicate the substance is not clastogenic.
 Carcinogenicity
The carcinogenicity of magnesium sulfate was tested via inhalation exposure in male Wistar rats (MRID 50871305). Rats (27/group) were exposed for one year (5 days per week, 6 hours per day) to long and short magnesium sulfate whiskers (diameter 1.8 μm and 1.5 μm, respectively). A subchronic 4-week study co-occurred with this yearlong study using an additional 124 animals (42, 42, and 40 rats per group for short whiskers, long whiskers, and controls, respectively). Long and short whiskers were tested at mean concentrations of 4.0 mg/m[3] and 2.3 mg/m[3], respectively. There were few whiskers detected in rat lungs, even immediately following exposure indicating the substance dissolved and was eliminated quickly. A parallel study in hamsters indicated the half-life of whiskers in lungs was 17.6 minutes. Histopathological examination of the rats indicated that the lung tumor incidence was not significantly different from that of control rats. Based on the results of this study, magnesium sulfate is unlikely to be carcinogenic.

Although no oral or dermal cancer or long-term studies are available to evaluate the carcinogenic potential of magnesium sulfate, no target organ toxicity was seen in the repeat dose study and no genotoxic or mutagenic effects were seen in the bacterial reverse mutation test and the in vitro mammalian chromosome aberration test (Section 5.4). It is therefore, unlikely that magnesium sulfate is carcinogenic.

 Neurotoxicity

No neurotoxicity studies are available for magnesium sulfate. Functional Observational Battery (FOB) tests were carried out as part of the OECD Test Guideline 422 study (MRID 50871314) described above in section 5.2.1. FOB observations included: clinical observations on central and autonomic nervous system effects, motor activity and behavior examination of all dosed animals once before dosing and once per week throughout the dosing and recovery periods. There were no effects of magnesium sulfate noted on sensory functions or motor activities when compared to control animals.

 Immunotoxicity

No immunotoxicity studies are available for magnesium sulfate; however, no effects were seen in the OECD Test Guideline 422 study (MRID 50871314), described above in section 5.2.1, that would indicate that magnesium sulfate would be immunotoxic. Furthermore, considering magnesium and sulfate are both essential nutrients in the diet and endogenous compounds, it is unlikely that they are immunotoxic.

 TOXICITY ENDPOINT SELECTION

Magnesium and sulfate are both abundant in the natural enviroment and are necessary for human life. Magnsium sulfate is commonly found in our food and water either as a naturally occuring element or as an additive. It is also broadly used in pharmaceuticals, fertilizers, and cosmetics. No toxicological endpoint of concern has been identified in the database; therefore, a quantitative assessment of human exposure is not necessary.

 SPECIAL CONSIDERATION for INFANTS and CHILDREN

FFDCA Section 408(b)(2)(c) provides that EPA shall apply an additional tenfold (10X) margin of safety for infants and children in the case of threshold effects to account for prenatal and postnatal toxicity and the completeness of the database on toxicity and exposure unless EPA determines based on reliable data that a different margin of safety will be safe for infants and children. This additional margin of safety is commonly referred to as the FQPA safety factor (SF). In applying this provision, EPA either retains the default value of 10X or uses a different additional safety factor when reliable data available to EPA support the choice of a different factor.

As part of its qualitative assessment, the Agency did not use safety factors for assessing risk, and no additional safety factor is needed for assessing risk to infants and children. The available acute and repeat dose toxicity studies on magnesium sulfate indicate that it has low toxicity. There is also no indication, based upon the available data, that magnesium sulfate is neurotoxic or immunotoxic, and it therefore would not result in increased susceptibility in infants or children. Taking into consideration all available information, there is no concern, at this time, for increased sensitivity to infants and children to magnesium sulfate.

 EXPOSURE

Magnesium sulfate is currently approved for use under 40 CFR §180.910 as an inert ingredient pre- and post-harvest. A review of currently approved pesticide products containing magnesium sulfate found that the majority of products were lawn care products and products used in pools. Ecolab, Inc. is requesting that EPA establish an exemption from the requirement of a tolerance for magnesium sulfate under 40 CFR §180.940(a) for use in antimicrobial formulations applied to food-contact surfaces in public eating places, dairy-processing equipment, and food-processing equipment and utensils at a maximum concentration of 4400 ppm.
Based on the current and proposed use pattern of magnesium sulfate, dietary and residential exposure from pesticidal uses are expected. In addition, humans are constantly exposed to magnesium sulfate as it is ubiquitous in the environment. However, no toxicological endpoint of concern was identified in the database; therefore, a quantitative risk assessment was not necessary.
 Dietary Exposure
Dietary exposure to magnesium sulfate may occur from eating foods treated with pesticide formulations containing this inert ingredient and drinking water containing runoff from soils containing the treated crops. In addition, magnesium sulfate is also used as an additive in food and beverages and in dietary supplements. However, no toxicological endpoint of concern was identified, and therefore a quantitative dietary exposure assessment for magnesium sulfate was not conducted.

 Residential Exposure

The term "residential exposure" is used in this document to refer to non-occupational, non-dietary exposure (e.g., for lawn and garden pest control, indoor pest control, termiticides, and flea and tick control on pets). Magnesium sulfate is currently used in both pesticide products and non-pesticidal products (e.g., cosmetics, pharmaceuticals, and fertilizers) that can result in residential exposure.  Although the current and proposed uses of magnesium sulfate can result in residential exposures to magnesium sulfate, there are no toxicological effects of concern in available studies, and therefore it is not necessary to conduct a quantitative assessment of residential (non-occupational) exposures and risks.

 Occupational Exposure/Risk
The Agency has reviewed the available toxicological information for magnesium sulfate and found that there are no adverse toxicological effects observed; therefore, a quantitative occupational risk assessment is not necessary.

 AGGREGATE EXPOSURE

The Federal Food, Drug, and Cosmetic Act (FFDCA) section 408  directs EPA to consider available information concerning exposure from the pesticide residue in food and other non-occupational exposures to determine 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.

Because no adverse effect was seen in the toxicity database for the magnesium sulfate a qualitative risk assessment was conducted and subsequently, it is not necessary to aggregate dermal and inhalation residential exposures with estimated dietary exposures.

    CUMULATIVE EXPOSURE

Section 408(b)(2)(D)(v) of the 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 magnesium sulfate to share a common mechanism of toxicity with any other substances, and magnesium sulfate does do not appear to produce a toxic metabolite produced by other substances. For the purposes of this tolerance action, therefore, EPA assumed that magnesium sulfate does not have a common mechanism of toxicity with other substances. For further 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.

    ENVIRONMENTAL FATE & EFFECTS

Magnesium sulfate is expected to have a minimal impact on the environment based on its physical and chemical characteristics and the fact that magnesium and sulfate are found naturally in the environment. Magnesium sulfate occurs naturally in sea water, mineral springs and in minerals such as kieserite (i.e., magnesium sulfate monohydrate) and epsomite (i.e., magnesium sulfate heptahydrate). Magnesium is one of the 10 most common elements in the Earth's crust.

 Environmental Fate

Magnesium sulfate is ubiquitous in the environment and living things. According to the OECD (MRID 50871314):

      Environmental fate analysis based on log Kow and log Koc and typical fugacity modelling are not applicable to magnesium sulphate due to its inorganic properties. Photodegradation and biodegradation are also not applicable to an inorganic metal salt like magnesium sulfate. Given its high solubility in water, magnesium sulfate will dissociate and release Mg2+ and SO4[2-] ions. The dissociated Mg[2+] cation can then transform and form complexes with dissolved ligands present in natural waters. Under anaerobic conditions, the dissociated sulfate ion is reduced to sulfide ion, which establishes an equilibrium with hydrogen ion to hydrogen sulphide. As a macronutrient, magnesium is widespread in living cells and so it is not expected to bioconcentrate in aquatic organisms.

 Ecotoxicity Data

Magnesium and sulfate occur in natural water systems and are found abundantly in the earth's crust. Ecotoxicity studies conducted with magnesium sulfate showed that it was not toxic to fish, invertebrates, or algae. The ecotoxicity data presented below has been taken from the 2010 OECD review of magnesium sulfate (MRID 50871314) and the 2010 Van Dam study (MRID 50871320) in which he looked at the effect of magnesium sulfate on six freshwater species.

The results of these studies are summarized in Table 3 and detailed in the sections below.

Table 3: Toxicity of Magnesium Sulfate to Aquatic Species
Species
Endpoint
LC50/IC50*(mg/L)
Source
 Fish
Oryzias latipes
 96-hr survival
 >96.4
 MRID 50871314
Pimephales promelas
 96-hr survival
 2820
 MRID 50871314
Mogurnda mogurnda
 96-hr survival
 198
 MRID 50871320
 Water Flea
Daphnia magna
 48-hr mobility
 >88.7
 MRID 50871314
Daphnia magna
 48-hr survival
 1820
 MRID 50871314
Moinodaphnia macleayi
 3 brood reproduction
 312
 MRID 50871320
 Snail
Amerianna cumingi
 96-hr embryo production
 64
 MRID 50871320
Algae
Chlorella sp.
 72-hr cell division
 6014
 MRID 50871320
Pseudokirchnerella
subcapitata
 72-hr growth rate
 72-hr yield
 >99.2 ErC50
 >99.2 EyC50
 MRID 50871314
 Aquatic Plants
Hydra viridissima
 96-hr growth
 54
 MRID 50871320
Lemma aequinoctialis
 96-hr growth
 22
 MRID 50871320
*acute median lethal concentration (LC50)/ chronic median inhibition concentration (IC50)

    Fish

The test substance was not toxic to fish in the three studies described below. The first two studies listed below are outlined in the OECD SIDS document on magnesium sulfate (MRID 50871314).

In an acute toxicity study (OECD Test Guideline 203), groups of 7 Japanese rice fish (Oryzias latipes) were exposed under static conditions to 100 mg/L of magnesium sulfate for 96 hours. There were no mortalities or adverse effects observed in any of the fish. The 96 hr-LC50 was greater than 96.4 mg/L (measured concentration).

A fish toxicity study (96 hours) in Fathead minnows (Pimephales promelas) was conducted under static conditions. The LC50 was 2,820 mg/L (nominal concentration).

Van Dam et al. (2010) tested the acute toxicity of magnesium sulfate (MRID 50871320)
in six tropical freshwater species (Chlorella sp., Lemna aequinoctialis, Amerianna cumingi, Moinodaphnia macleayi, Hydra viridissima, and Mogurnda mogurnda). The Northern Trout Gudgeon (Mogurnda mogurnda) showed a 96 hr-LC50 of 198 mg/L.
    Aquatic Invertebrates: Water Flea
The test substance was not toxic to aquatic invertebrates in the three studies described below. The first two studies are outlined in the OECD SIDS document (MRID 50871314).

Daphnia magna (groups of 20 organisms) were observed for immobilization at 24 and 48 hours following static exposure to concentrations of magnesium sulfate of 100 mg/L and control. The study was conducted according to OECD Test Guideline 202 "Daphnia sp., Acute Immobilization Test". No immobility was observed at the tested concentrations. Based on these results, the EC50 was >88.7 mg/L (measured concentration) after 48-hour exposure.
In an acute toxicity test in invertebrate, Daphnia magna were exposed under static condition to magnesium sulfate for 48 hours. The LC50 of magnesium sulfate was 1,820 mg/L (nominal concentration).
In the Van Dam study (MRID 50871320), Moinodaphnia macleayi showed little response to magnesium concentrations up to approximately 40 mg/L, with an IC50 of 63 mg/L and 312 mg/L for Mg and MgSO4, respectively.
 Algae
A 72-hour growth inhibition test (OECD Test Guideline 201) of 100 mg/L magnesium sulfate was conducted with Pseudokirchneriella subcapitata. Based on the results, the 72-hour ErC50 (average specific growth rate) and the EyC50 (yield) were > 99.2 mg/L (mean measured concentrations) (MRID 50871314).
Of the six freshwater organisms tested in the Van Dam study (MRID 50871320), Chlorella sp. was clearly the least sensitive species to Mg exposure showing little response to Mg concentrations of approximately 80 mg/L, with an IC50 of approximately 1,200 mg/L. The IC50 for MgSO4 was 6000 mg/L.

    RISK CHARACTERIZATION

Magnesium sulfate is ubiquitous in the environment and is currently approved for use as a food use inert ingredient (solid diluent, carrier, safener) in pesticide products under 40 CFR § 180.910 for use pre- and post-harvest. It is also used in various other non-pesticidal food and consumer products, including pharmaceuticals, dietary supplements, fertilizers, cosmetics, and as a food and beverage additive. One form, magnesium sulfate heptahydrate, also known as Epsom salt, has been used for centuries as an over the counter laxative and a soaking agent for aching joints.

Available acute studies on magnesium sulfate include an oral toxicity study, a dermal irritation study, and a dermal sensitization study. Repeat dose toxicity testing for magnesium sulfate includes an OECD Test Guideline 422: Combined Repeat Dose Reproduction/Developmental Toxicity Screening Test and a 1-year inhalation cancer study in rats. Magnesium sulfate was also tested for genotoxic and/or mutagenic effects using a bacterial reverse mutation test and an in vitro mammalian chromosome aberration test.

All studies showed low acute and repeat dose toxicity and no reproductive/developmental toxicity. The primary health effect associated with magnesium sulfate is an osmotic laxative effect at high doses. The laxative effect is transient, and recovery is rapid and is usually observed only when following acute exposures to high concentrations (e.g., pharmacological uses). In the acute oral study, diarrhea was seen at the highest dose tested (2000 mg/kg/day); however, this effect was seen above the limit dose of 1,000 mg/kg/day and therefore would not be used as point of departure for determining risk.

The OECD Test Guideline 422 study showed no adverse effect at the NOAEL of 450 mg/kg/day, the highest dose tested. In addition, there was no evidence of carcinogenicity or neuropathological changes or effects reported in any of the studies. The agency does not believe magnesium sulfate is carcinogenic or neurotoxic.

Based on the current and proposed use patterns of magnesium sulfate, dietary and residential exposure from pesticidal uses are expected. However, no toxicological endpoint of concern was identified in the database; therefore, a quantitative risk assessment was not necessary. As part of its qualitative assessment, the Agency did not use safety factors for assessing risk, and no additional safety factor is needed for assessing risk to infants and children.

Magnesium sulfate is found naturally in water, and based on various aquatic studies, it does not present a hazard for aquatic systems or the environment. Overall, the widespread use of magnesium sulfate in foods, drugs, and cosmetics, in combination with the natural occurrence of both magnesium and sulfate in the body, indicate that this compound does not pose a safety risk from these uses.

                                 Bibliography

(MRID 50871303) Cosmetic Ingredient Review (CIR). 2014. Safety Assessment of Magnesium Sulfate as Used in Cosmetics. Expert Panel Review - Final Report, Release Date: June 26, 2014, Panel Date:  June 9-10, 2014. Expert Panel: Wilma F. Bergfeld, M.D., F.A.C.P.; Donald V. Belsito, M.D.; Curtis D. Klaassen, Ph.D.; Daniel C. Liebler, Ph.D.; Ronald A Hill, Ph.D. James G. Marks, Jr., M.D.; Ronald C. Shank, Ph.D.; Thomas J. Slaga, Ph.D.; and Paul W. Snyder, D.V.M., Ph.D.

(MRID 50871305) Hori, H. Kasai T. Haratake J. Ishimatsu S. Oyabu T. Yamato H. Higashi T. and Tanaka T. Biological effects of inhaled magnesium sulphate whiskers in rats. Occup.Environ.Med. 1994;51(7):492-499.

(MRID 50871307) Institute of Medicine (IOM). 2005. Dietary reference intakes for water, potassium, sodium, chloride, and sulfate. Washington, DC, USA, The National Academies Press, https://doi.org/10.17226/10925.

(MRID 50871309) Joint FAO/WHO Expert Committee on Food Additive (JECFA). 2007. Sixty-eighth report of the Joint FAO/WHO Expert Committee on Food Additives. WHO technical report series: no. 947.

(MRID 50871311) Office of Dietary Supplements (ODS). 2018. Dietary Supplement Fact Sheet: Magnesium. Office of Dietary Supplements, US National Institutes of Health. Updated: September 26, 2018.

(MRID 50871314) Organization for Economic Cooperation and Development (OECD). 2010. Magnesium sulfate. SIDS Initial Assessment Report for SIAM 31. 19-20 October 2010, Paris. Sponsor Country: Republic of Korea, Date of submission: July 14, 2010.

(MRID 50871317) Seo, JW and Park, TJ. 2008. Magnesium metabolism. Electrolyte & Blood Pressure 6:86-95.

U.S. Environmental Protection Agency (EPA). 2003. Drinking Water Advisory: Consumer Acceptability Advice and Health Effects Analysis on Sulfate. Office of Water (4304T). Health and Ecological Criteria Division. EPA 822-R-03-007. February 2003.

(MRID 50871320) Van Dam RA, Hogan AC, McCullough CD, Houston MA, Humphrey CL, Harford AJ. 2010. Aquatic toxicity of magnesium sulfate, and the influence of calcium, in very low ionic concentration water. Environ Toxicol Chem. 2010 Feb;29(2):410-21.

(MRID 50871321) World Health Organization (WHO). 2004. Sulfate in Drinking-water Background document for development of WHO Guidelines for Drinking-water Quality. WHO/SDE/WSH/03.04/11


[Federal Register Volume 85, Number 151 (Wednesday, August 5, 2020)]
[Rules and Regulations]
[Page 47295]
[FR Doc No: 2020-16060]

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

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Parts 21, 61, 63, 65, 91, 107, 125, and 141

[Docket No.: FAA-2020-0446; Amdt. No(s). Amendment Numbers 1-103, 61-
146, 63-44, 65-61, 91-358, 107-4, 125-70, and 141-22]
RIN 2120-AL64

Limited Extension of Relief for Certain Persons and Operations
During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency

AGENCY: Federal Aviation Administration (FAA), Department of
Transportation (DOT).

ACTION: Final rule; correction.

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

SUMMARY: The FAA is correcting a final rule published on June 29, 2020
in which the FAA amended regulatory relief originally provided in the
Relief for Certain Persons and Operations during the Coronavirus
Disease 2019 (COVID-19) final rule. The FAA inadvertently listed
incorrect amendment numbers for the final rule. This document corrects
that error.

DATES: Effective August 5, 2020 through March 31, 2021.

FOR FURTHER INFORMATION CONTACT: For technical questions concerning
this action for pilots, contact Craig Holmes, General Aviation and
Commercial Division; Federal Aviation Administration, 800 Independence
Avenue SW, Washington, DC 20591; telephone<PHONE_NUMBER>; email<EMAIL_ADDRESS>For technical questions
concerning this action for mechanics and special flight permits,
contact Kevin Morgan, Aircraft Maintenance Division; Federal Aviation
Administration, 800 Independence Avenue SW, Washington, DC 20591;
telephone<PHONE_NUMBER>; email<EMAIL_ADDRESS>For technical
questions concerning this action for aircraft dispatchers and flight
engineers, contact Theodora Kessaris and Sheri Pippin, Air
Transportation Division, Federal Aviation Administration, 800
Independence Avenue SW, Washington, DC 20591; telephone<PHONE_NUMBER>;
email<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

Good Cause for Adoption Without Prior Notice

    Section 553(b)(3)(B) of the Administrative Procedure Act (APA) (5
U.S.C. 551 et seq.) authorizes agencies to dispense with notice and
comment procedures for rules when the agency for ``good cause'' finds
that those procedures are ``impracticable, unnecessary, or contrary to
the public interest.'' In addition, section 553(d) of the APA requires
that agencies publish a rule not less than 30 days before its effective
date, except a substantive rule that relieves a restriction or ``as
otherwise provided by the agency for good cause found and published
with the rule.'' 5 U.S.C. 553(d)(1) and (3).
    Because this action merely makes a correction to the amendment
number of a published final rule, the FAA finds that notice and public
comment under 5 U.S.C. 553(b) is unnecessary. For the same reason, the
FAA finds that good cause exists under 5 U.S.C. 553(d) for making this
rule effective in less than 30 days.

Background

    On June 29, 2020, the FAA published the Limited Extension of Relief
for Certain Persons and Operations during the Coronavirus Disease 2019
(COVID-19) Public Health Emergency final rule (85 FR 38763). After that
rule was published, the FAA discovered a minor error with the amendment
numbers listed in heading of the final rule that required correction.
The final rule listed the amendment numbers as Amdt. No(s). 21-102, 61-
145, 63-43, 65-60, 91-357, 107-3, 125-69, and 141-21.

Correction

    In the final rule, FR Doc. 2020-13960, published on June 29, 2020,
at 85 FR 38763 make the following correction:
    1. On page 38763 in the heading of the final rule, revise ``Amdt.
No(s). 21-102, 61-145, 63-43, 65-60, 91-357, 107-3, 125-69, and 141-
21'' to read ``1-103, 61-146, 63-44, 65-61, 91-358, 107-4, 125-70, and
141-22''.
    Issued under authority provided by 49 U.S.C. 106(f), 106(g),
44701(a), and Sec. 206 of Public Law 111-216, 124 Stat. 2348 (49 U.S.C.
44701 note) in Washington, DC, on July 17, 2020.

Brandon Roberts,
Executive Director, Office of Rulemaking.
[FR Doc. 2020-16060 Filed 8-4-20; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register: May 13, 2009 (Volume 74, Number 91)]
[Notices]
[Page 22534-22536]
[DOCID:fr13my09-43]

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

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Combined Notice of Filings 2

May 5, 2009.
    Take notice that the Commission received the following electric
corporate filings:

    Docket Numbers: EC09-76-000.
    Applicants: Trans Bay Cable LLC.
    Description: Application for Authorization to Dispose of
Jurisdictional Facilities and for Expedited Treatment of Trans Bay
Cable LLC.
    Filed Date: 04/29/2009.
    Accession Number: 20090429-5021.
    Comment Date: 5 p.m. Eastern Time on Wednesday, May 20, 2009.

    Docket Numbers: EC09-77-000.
    Applicants: Entergy Arkansas Inc., Entergy Gulf States, Inc.
    Description: Entergy Arkansas, Inc. et al. submits their
Application for Order Authorizing Disposition and Acquisition of
Jurisdictional Assets under Section 203 of the Federal Power Act.
    Filed Date: 04/30/2009.
    Accession Number: 20090505-0016.
    Comment Date: 5 p.m. Eastern Time on Thursday, May 21, 2009.

    Take notice that the Commission received the following electric
rate filings:

    Docket Numbers: ER09-683-002.
    Applicants: Alex Energy, LLC.

    Description: Alex Energy LLC submits supplement to its application
for a Finding of Category 1 Seller Status.
    Filed Date: 04/30/2009.
    Accession Number: 20090504-0187.
    Comment Date: 5 p.m. Eastern Time on Thursday, May 21, 2009.

    Docket Numbers: ER08-1051-003.
    Applicants: NSTAR Electric Company.
    Description: NSTAR Electric Company submits its Annual
Informational Filing.
    Filed Date: 04/27/2009.
    Accession Number: 20090428-0018.
    Comment Date: 5 p.m. Eastern Time on Monday, May 18, 2009.

    Docket Numbers: ER09-701-001.
    Applicants: PJM Interconnection LLC.
    Description: PJM Response to FERC Deficiency Letter.
    Filed Date: 04/28/2009.
    Accession Number: 20090428-5214.
    Comment Date: 5 p.m. Eastern Time on Tuesday, May 19, 2009.

    Docket Numbers: ER09-883-001.
    Applicants: Southwest Power Pool, Inc.
    Description: Southwest Power Pool, Inc submits amendatory filing
updated agreement with revised Exhibit A to replace the agreement
submitted on 3/23/09.
    Filed Date: 04/29/2009.
    Accession Number: 20090430-0320.
    Comment Date: 5 p.m. Eastern Time on Wednesday, May 20, 2009.

    Docket Numbers: ER09-1052-000.
    Applicants: Pacific Gas and Electric Company.
    Description: Pacific Gas and Electric Co's Twenty-Fifth Quarterly
Filing of Facilities Agreements.
    Filed Date: 04/29/2009.
    Accession Number: 20090430-0243.
    Comment Date: 5 p.m. Eastern Time on Wednesday, May 20, 2009.

    Docket Numbers: ER09-1053-000.
    Applicants: PJM Interconnection LLC.
    Description: PJM Interconnection, LLC submits an executed Interim
Interconnection Service Agreement with ExelonGgeneration Co, LLC etc.
    Filed Date: 04/28/2009.
    Accession Number: 20090430-0242.
    Comment Date: 5 p.m. Eastern Time on Tuesday, May 19, 2009.

    Docket Numbers: ER09-1054-000.
    Applicants: San Diego Gas & Electric Company.
    Description: San Diego Gas & Electric Company tenders for filing
Engineering and Procurement Agreement dated 4/14/09 with Iberdrola
Renewables, Inc.
    Filed Date: 04/28/2009.
    Accession Number: 20090430-0171.
    Comment Date: 5 p.m. Eastern Time on Tuesday, May 19, 2009.

    Docket Numbers: ER09-1055-000.
    Applicants: Southwest Power Pool, Inc.
    Description: Southwest Power Pool, Inc submits Original Service
Agreement 1782 to its FERC Electric Tariff, Fifth Revised Volume 1.
    Filed Date: 04/28/2009.
    Accession Number: 20090430-0170.
    Comment Date: 5 p.m. Eastern Time on Tuesday, May 19, 2009.

    Docket Numbers: ER09-1061-000.
    Applicants: Woodland Biomass Power Ltd.
    Description: Application of Woodland Biomass Power LTD for Blanket
Authorizations, including pursuant to 18 CFR Part 34 for all future
issuances of securities and assumptions of liability, certain waivers,
and order approving market-based rate tariff.
    Filed Date: 04/30/2009.
    Accession Number: 20090501-0157.
    Comment Date: 5 p.m. Eastern Time on Thursday, May 21, 2009.

    Docket Numbers: ER09-1062-000.
    Applicants: Tampa Electric Company.
    Description: Tampa Electric Company submits revised rate schedule
sheets for inclusion in the rate schedules comprising Tampa Electric's
bilateral interchange contracts with 16 other utilities.
    Filed Date: 04/29/2009.
    Accession Number: 20090430-0176.
    Comment Date: 5 p.m. Eastern Time on Wednesday, May 20, 2009.

    Docket Numbers: ER09-1064-000.
    Applicants: California Independent System Operator Corporation.
    Description: California Independent System Operator Corporation
submits amendments to the effective CAISO Tariff to implement a
resource adequacy standard capacity product, et al.
    Filed Date: 04/28/2009.
    Accession Number: 20090430-0329.
    Comment Date: 5 p.m. Eastern Time on Tuesday, May 19, 2009.

    Docket Numbers: ER09-1065-000.
    Applicants: PJM Interconnection LLC.
    Description: PJM Interconnection, LLC submits an executed
interconnection service agreement entered into PJM, et al.
    Filed Date: 04/29/2009.
    Accession Number: 20090430-0318.
    Comment Date: 5 p.m. Eastern Time on Wednesday, May 20, 2009.

    Docket Numbers: ER09-1066-000.
    Applicants: California Power Exchange Corporation.
    Description: The California Power Exchange Corporation submits for
filing Original Sheet 10 et al. to its FERC Rate Schedule 1.
    Filed Date: 04/29/2009.
    Accession Number: 20090430-0322.
    Comment Date: 5 p.m. Eastern Time on Wednesday, May 20, 2009.

    Docket Numbers: ER09-1067-000.
    Applicants: Entergy Services, Inc.
    Description: Entergy Texas, Inc. submits Rate Schedule 198
providing for cost-based power sales for full requirements service to
Brazos Electric Power Coop, Inc.
    Filed Date: 04/29/2009.
    Accession Number: 20090430-0324.
    Comment Date: 5 p.m. Eastern Time on Wednesday, May 20, 2009.

    Docket Numbers: ER09-1068-000.
    Applicants: Southwest Power Pool, Inc.
    Description: Southwest Power Pool, Inc. submits Meter Agent
Services Agreement between Dogwood Energy, LLC as the Market
Participant and KCP&L Greater Missouri Operations Company as the Meter
Agent.
    Filed Date: 04/29/2009.
    Accession Number: 20090430-0319.
    Comment Date: 5 p.m. Eastern Time on Wednesday, May 20, 2009.

    Docket Numbers: ER09-1069-000.
    Applicants: Southwest Power Pool, Inc.
    Description: Southwest Power Pool, Inc. submits Service Agreement
for Network Integration Transmission Service between SPP and OPPD, et
al.
    Filed Date: 04/30/2009.
    Accession Number: 20090501-0141.
    Comment Date: 5 p.m. Eastern Time on Thursday, May 21, 2009.

    Docket Numbers: ER09-1070-000.
    Applicants: Southwest Power Pool, Inc.
    Description: Southwest Power Pool, Inc. submits Service Agreement
for Network Integration Transmission Service between SPP as
Transmission Provider and NNPPD as Network Customer, et al.
    Filed Date: 04/30/2009.
    Accession Number: 20090501-0140.
    Comment Date: 5 p.m. Eastern Time on Thursday, May 21, 2009.

    Docket Numbers: ER09-1071-000.
    Applicants: Xcel Energy Services Inc.
    Description: Southwestern Public Service Company submits Service
Agreement No. 614-SPS et al.
    Filed Date: 04/30/2009.
    Accession Number: 20090501-0139.
    Comment Date: 5 p.m. Eastern Time on Thursday, May 21, 2009.

    Docket Numbers: ER09-1072-000.
    Applicants: El Paso Electric Company.
    Description: El Paso Electric Company submits Interconnection
Agreement between El Paso Electric Company and Tri State Generation and
Transmission Association, Inc., et al.
    Filed Date: 04/30/2009.

    Accession Number: 20090501-0138.
    Comment Date: 5 p.m. Eastern Time on Thursday, May 21, 2009.

    Docket Numbers: ER09-1073-000.
    Applicants: Westar Energy, Inc.
    Description: Westar Energy, Inc. submits Service Agreement No. 1.
    Filed Date: 04/30/2009.
    Accession Number: 20090501-0136.
    Comment Date: 5 p.m. Eastern Time on Thursday, May 21, 2009.

    Docket Numbers: ER09-1074-000.
    Applicants: Midwest Independent Transmission System Operator, Inc.
    Description: Midwest Independent Transmission System Operator,
Inc., et al. submits Capacity Portability Service Agreement between
Buckeye Power, Incorporated, etc.
    Filed Date: 04/30/2009.
    Accession Number: 20090501-0137.
    Comment Date: 5 p.m. Eastern Time on Thursday, May 21, 2009.

    Docket Numbers: ER09-1076-000.
    Applicants: Florida Power & Light Company.
    Description: Florida Power & Light Company submits for filing
Original Sheet 1, et al. FERC Rate Schedule 318.
    Filed Date: 04/30/2009.
    Accession Number: 20090501-0142.
    Comment Date: 5 p.m. Eastern Time on Thursday, May 21, 2009.

    Take notice that the Commission received the following electric
securities filings:

    Docket Numbers: ES09-29-000.
    Applicants: Entergy Louisiana, LLC.
    Description: Application of Entergy Louisiana, LLC, for
Authorization under Federal Power Act Section 204.
    Filed Date: 04/29/2009.
    Accession Number: 20090429-5199.
    Comment Date: 5 p.m. Eastern Time on Wednesday, May 20, 2009.

    Docket Numbers: ES09-30-000.
    Applicants: Entergy Gulf States Louisiana, LLC.
    Description: Application of Entergy Gulf States Louisiana, LLC.,
for Authorization under Federal Power Act Section 204.
    Filed Date: 04/29/2009.
    Accession Number: 20090429-5201.
    Comment Date: 5 p.m. Eastern Time on Wednesday, May 20, 2009.

    Take notice that the Commission received the following open access
transmission tariff filings:

    Docket Numbers: OA08-50-003.
    Applicants: Duke Energy Carolinas, LLC.
    Description: Duke Energy Carolinas, LLC submits First Revised Sheet
No. 32, et al. to FERC Electric Tariff, Sixth Revised Volume No. 4.
    Filed Date: 04/29/2009.
    Accession Number: 20090430-0172.
    Comment Date: 5 p.m. Eastern Time on Wednesday, May 20, 2009.

    Any person desiring to intervene or to protest in any of the above
proceedings must file in accordance with Rules 211 and 214 of the
Commission's Rules of Practice and Procedure (18 CFR 385.211 and
385.214) on or before 5 p.m. Eastern time on the specified comment
date. It is not necessary to separately intervene again in a subdocket
related to a compliance filing if you have previously intervened in the
same docket. Protests will be considered by the Commission in
determining the appropriate action to be taken, but will not serve to
make protestants parties to the proceeding. Anyone filing a motion to
intervene or protest must serve a copy of that document on the
Applicant. In reference to filings initiating a new proceeding,
interventions or protests submitted on or before the comment deadline
need not be served on persons other than the Applicant.
    The Commission encourages electronic submission of protests and
interventions in lieu of paper, using the FERC Online links at http://
www.ferc.gov. To facilitate electronic service, persons with Internet
access who will eFile a document and/or be listed as a contact for an
intervenor must create and validate an eRegistration account using the
eRegistration link. Select the eFiling link to log on and submit the
intervention or protests.
    Persons unable to file electronically should submit an original and
14 copies of the intervention or protest to the Federal Energy
Regulatory Commission, 888 First St. NE., Washington, DC 20426.
    The filings in the above proceedings are accessible in the
Commission's eLibrary system by clicking on the appropriate link in the
above list. They are also available for review in the Commission's
Public Reference Room in Washington, DC. There is an eSubscription link
on the Web site that enables subscribers to receive e-mail notification
when a document is added to a subscribed dockets(s). For assistance
with any FERC Online service, please e-mail<EMAIL_ADDRESS>or call<PHONE_NUMBER> (toll free). For TTY, call<PHONE_NUMBER>.

Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. E9-11070 Filed 5-12-09; 8:45 am]

BILLING CODE 6717-01-P


[Federal Register Volume 81, Number 63 (Friday, April 1, 2016)]
[Notices]
[Pages 18860-18861]
[FR Doc No: 2016-07362]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2016-N-0001]

Advisory Committee; Arthritis Advisory Committee, Renewal

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; renewal of advisory committee.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing the
renewal of the Arthritis Advisory Committee by the Commissioner of Food
and Drugs (the Commissioner). The Commissioner has determined that it
is in the public interest to renew the Arthritis Advisory Committee for
an additional 2 years beyond the charter expiration date. The new
charter will be in effect until April 5, 2018.

DATES: Authority for the Arthritis Advisory Committee will expire on
April 5, 2018, unless the Commissioner formally determines that renewal
is in the public interest.

FOR FURTHER INFORMATION CONTACT: Stephanie L. Begansky, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 31, Rm. 2417, Silver Spring, MD 20993-0002, 301-
796-9001<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Pursuant to 41 CFR 102-3.65 and approval by
the Department of Health and Human Services pursuant to 45 CFR part 11
and by the General Services Administration, FDA is announcing the
renewal of the Arthritis Advisory Committee (the Committee). The
Committee is a discretionary Federal advisory committee established to
provide advice to the Commissioner. The Committee advises the
Commissioner or designee in discharging responsibilities as they relate
to helping to ensure safe and effective drugs for human use and, as
required, any other product for which FDA has regulatory
responsibility. The Committee reviews and evaluates data concerning the
safety and effectiveness of marketed and investigational human drug
products for use in the treatment of arthritis, rheumatism, and related
diseases, and makes appropriate recommendations to the Commissioner.
    The Committee shall consist of a core of 11 voting members
including the Chair. Members and the Chair are selected by the
Commissioner or designee from among authorities knowledgeable in the
fields of arthritis, rheumatology, orthopedics, epidemiology or
statistics, analgesics, and related specialties. Members will be
invited to serve for overlapping terms of up to 4 years. Almost all
non-Federal members of this committee serve as Special Government
Employees. The core of voting members may include one technically
qualified member, selected by the Commissioner or designee, who is
identified with consumer interests and is recommended by either a
consortium of consumer-oriented organizations or other interested
persons. In addition to the voting members, the Committee may include

one non-voting member who is identified with industry interests.
    Further information regarding the most recent charter and other
information can be found at http://www.fda.gov/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/ArthritisAdvisoryCommittee/ucm094137.htm or by contacting the Designated Federal Officer (see FOR
FURTHER INFORMATION CONTACT). In light of the fact that no change has
been made to the committee name or description of duties, no amendment
will be made to 21 CFR 14.100.
    This document is issued under the Federal Advisory Committee Act (5
U.S.C. app.). For general information related to FDA advisory
committees, please visit us at http://www.fda.gov/AdvisoryCommittees/default.htm.

    Dated: March 25, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-07362 Filed 3-31-16; 8:45 am]
 BILLING CODE 4164-01-P