80 FR 34637 - Availability of Health Effects Support Documents and Drinking Water Health Advisories for Cyanobacterial Toxins; and a Support Document Containing Recommendations for Managing Cyanotoxins in Drinking Water

ENVIRONMENTAL PROTECTION AGENCY

Federal Register Volume 80, Issue 116 (June 17, 2015)

Page Range		34637-34638
FR Document		2015-14936

The Environmental Protection Agency (EPA) announces the release of Ten-Day Health Advisories (HAs) for two cyanobacterial toxins, microcystins and cylindrospermopsin. EPA also announces the release of Health Effect Support Documents (HESDs) for three cyanobacterial toxins: Microcystins, cylindrospermopsin, and anatoxin- a. The HESDs constitute a comprehensive review of the published literature on the chemical and physical properties of these toxins, the toxin synthesis and environmental fate, occurrence and exposure information, and health effects. The HESDs are used to develop HAs. Based on the reported occurrence, toxicology, and epidemiology data, EPA found there are adequate data to develop HAs for microcystins and cylindrospermopsin, but inadequate data to develop an HA for anatoxin- a. EPA's HAs provide states, drinking water utilities and the public with information on health effects of microcystins and cylindrospermopsin, analytical methods to test for cyanotoxins in water samples, and treatment technologies to remove cyanobacterial toxins in drinking water. Additionally, EPA announces a support document for states and utilities to assist them as they consider whether and how to manage cyanobacterial toxins in drinking water. The recommendations in this document are intended to assist public drinking water systems (PWSs) manage the risks from cyanobacterial toxins in drinking water, including information and a framework that PWSs can consider in their cyanotoxin risk management efforts.

Federal Register, Volume 80 Issue 116 (Wednesday, June 17, 2015)

[Federal Register Volume 80, Number 116 (Wednesday, June 17, 2015)]
[Notices]
[Pages 34637-34638]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2015-14936]


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ENVIRONMENTAL PROTECTION AGENCY

[EPA 820R15100, EPA 820R15101, EPA 820R15102, EPA 820R15103, EPA 
820R15104; EPA-815R15010; FRL-9929-28-OW]


Availability of Health Effects Support Documents and Drinking 
Water Health Advisories for Cyanobacterial Toxins; and a Support 
Document Containing Recommendations for Managing Cyanotoxins in 
Drinking Water

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice of availability.

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SUMMARY: The Environmental Protection Agency (EPA) announces the 
release of Ten-Day Health Advisories (HAs) for two cyanobacterial 
toxins, microcystins and cylindrospermopsin. EPA also announces the 
release of Health Effect Support Documents (HESDs) for three 
cyanobacterial toxins: Microcystins, cylindrospermopsin, and anatoxin-
a. The HESDs constitute a comprehensive review of the published 
literature on the chemical and physical properties of these toxins, the 
toxin synthesis and environmental fate, occurrence and exposure 
information, and health effects. The HESDs are used to develop HAs. 
Based on the reported occurrence, toxicology, and epidemiology data, 
EPA found there are adequate data to develop HAs for microcystins and 
cylindrospermopsin, but inadequate data to develop an HA for anatoxin-
a. EPA's HAs provide states, drinking water utilities and the public 
with information on health effects of microcystins and 
cylindrospermopsin, analytical methods to test for cyanotoxins in water 
samples, and treatment technologies to remove

[[Page 34638]]

cyanobacterial toxins in drinking water. Additionally, EPA announces a 
support document for states and utilities to assist them as they 
consider whether and how to manage cyanobacterial toxins in drinking 
water. The recommendations in this document are intended to assist 
public drinking water systems (PWSs) manage the risks from 
cyanobacterial toxins in drinking water, including information and a 
framework that PWSs can consider in their cyanotoxin risk management 
efforts.

FOR FURTHER INFORMATION CONTACT: For information regarding the HAs or 
HESDs: Lesley D'Anglada, Office of Water, Health and Ecological 
Criteria Division (4304T), Environmental Protection Agency, 1200 
Pennsylvania Avenue NW., Washington, DC 20460; telephone number: (202) 
566-1125; email address: [email protected]. For information 
regarding recommendations for cyanotoxin management in drinking water: 
Hannah Holsinger, Office of Water, Office of Ground Water and Drinking 
Water (4607M), Environmental Protection Agency, 1200 Pennsylvania 
Avenue NW., Washington, DC 20460; telephone number: (202) 564-0403; 
email address: [email protected].

SUPPLEMENTARY INFORMATION:

I. General Information

A. How can I get copies of this document and other related information?

    1. Electronic Access. You may access this Federal Register document 
electronically from the Government Printing Office under the ``Federal 
Register'' listings at FDSys (http://www.thefederalregister.org/fdsys/browse/collection.action?collectionCode=FR). The Health Effects Support 
Documents and the Health Advisories for the cyanobacterial toxins are 
available on EPA's Web site at http://water.epa.gov/drink/standards/hascience.cfm. The Recommendations for Public Water Systems to Manage 
Cyanotoxins in Drinking Water document is available on EPA's Web site 
at http://www2.epa.gov/nutrient-policy-data/guidelines-and-recommendations.

II. What are cyanobacterial toxins and how are they produced?

    Algae and cyanobacteria are natural components of fresh water; 
however, under favorable conditions, they can rapidly multiply causing 
``blooms.'' Some cyanobacterial species can produce toxins 
(cyanotoxins) at levels that may be of concern for human health. These 
cyanobacterial toxins are of particular concern because of their 
potential impacts on drinking water and the potential to affect human 
health.

III. What are EPA's Health Advisories?

    Under the Safe Drinking Water Act, EPA may publish Health 
Advisories (HAs) for contaminants that are not subject to any national 
primary drinking water regulation. 42 U.S.C. 300 g-1(b)(1)(F). EPA 
develops HAs to provide information on the chemical and physical 
properties, occurrence and exposure, health effects, quantification of 
toxicological effects, other regulatory standards, analytical methods, 
and treatment technology for drinking water contaminants. HAs describe 
concentrations of drinking water contaminants at which adverse health 
effects are not anticipated to occur over specific exposure durations 
(e.g., one-day, ten-days, several years, and a lifetime). HAs also 
contain a margin of safety to address database uncertainties. HAs serve 
as informal technical guidance to assist federal, state and local 
officials, as well as managers of public or community water systems in 
protecting public health when emergency spills or contamination 
situations occur. They are not regulations and should not be construed 
as legally enforceable federal standards. HAs may change as new 
information becomes available.

IV. Information on EPA's Ten-Day Health Advisories for the 
Cyanobacterial Toxins, Cylindrospermopsin and Microcystins

    Today, EPA is making available the HA values for the cyanobacterial 
toxins microcystins and cylindrospermopsin. EPA recommends 0.3 
micrograms per liter for microcystins and 0.7 micrograms per liter for 
cylindrospermopsin as levels not to be exceeded in drinking water for 
bottle-fed infants and young children of pre-school age. For school-age 
children through adults, the health advisory values for drinking water 
are 1.6 micrograms per liter for microcystins and 3 micrograms per 
liter for cylindrospermopsin. The HA values are based on exposure for 
ten days.

V. Information on EPA's Support Document To Assist States and Utilities 
in Managing Cyanobacterial Toxins

    EPA also announces the release of a cyanotoxin management document 
that is a companion to the HAs for microcystins and cylindrospermopsin. 
The document is intended to assist PWSs that choose to develop system-
specific plans for evaluating their source waters for vulnerability to 
contamination by microcystins and cylindrospermopsin. It provides 
information and a framework that PWSs and others (as appropriate) can 
consider to inform their decisions on managing the risks from 
cyanotoxins to drinking water.

    Dated: June 10, 2015.
Kenneth J. Kopocis,
Deputy Assistant Administrator, Office of Water.
[FR Doc. 2015-14936 Filed 6-16-15; 8:45 am]
 BILLING CODE 6560-50-P

Federal Register / Vol. 80, No. 116 / Wednesday, June 17, 2015 / Notices 34637

mixture; and describes the nature of the through Friday, excluding legal 3. Test Data Received: The following
test data received. Each chemical holidays. The telephone number for the listing describes the nature of the test
substance and/or mixture related to this Public Reading Room is (202) 566–1744, data received. The test data will be
announcement is identified in Unit I. and the telephone number for the OPPT added to the docket for the applicable
under SUPPLEMENTARY INFORMATION. Docket is (202) 566–0280. Please review TSCA section 4 test rule and can be
FOR FURTHER INFORMATION CONTACT: For the visitor instructions and additional found by referencing the docket ID
technical information contact: Kathy information about the docket available number provided. EPA reviews of test
Calvo, Chemical Control Division at http://www.epa.gov/dockets. data will be added to the same docket
(7405M), Office of Pollution Prevention upon completion.
IV. Test Data Received
and Toxics, Environmental Protection Aquatic Toxicity (Algal) (C6). The
Agency, 1200 Pennsylvania Ave. NW., This unit contains the information docket ID number assigned to this data
Washington, DC 20460–0001; telephone required by TSCA section 4(d) for the is EPA–HQ–OPPT–2007–0531.
number: (202) 564–8089; email address: test data received by EPA.
Authority: 15 U.S.C. 2601 et seq.
calvo.kathy@epa.gov. A. D-gluco-heptonic acid, monosodium Dated: June 8, 2015.
For general information contact: The salt, (2.xi.)- (CAS RN 31138–65–5). Maria J. Doa,
TSCA-Hotline, ABVI-Goodwill, 422
1. Chemical Uses: Organic salt used as Director, Chemical Control Division, Office
South Clinton Ave., Rochester, NY
a chelating agent in cosmetics, dairy of Pollution Prevention and Toxics.
14620; telephone number: (202) 554–
cleaners, bottle cleaners, food contact [FR Doc. 2015–14748 Filed 6–16–15; 8:45 am]
1404; email address: TSCA-Hotline@
paper and paperboard, manufacturing, BILLING CODE 6560–50–P
epa.gov.
metal cleaning, kier boiling, caustic
SUPPLEMENTARY INFORMATION: boil-off, paint stripping, boiler water
additive for food processing, and as an ENVIRONMENTAL PROTECTION
I. Chemical Substances and/or Mixtures
ingredient in aluminum etchant. This AGENCY
Information about the following chemical is also used as a sequestrant,
chemical substances and/or mixtures is [EPA 820R15100, EPA 820R15101, EPA
latex stabilizer, and in intravenous 820R15102, EPA 820R15103, EPA
provided in Unit IV.: pharmaceuticals. 820R15104; EPA–815R15010; FRL–9929–
A. D-gluco-heptonic acid, monosodium 2. Applicable Test Rule: Chemical 28–OW]
salt, (2.xi.)- (CAS RN 31138–65–5). testing requirements for second group of
high production volume chemicals Availability of Health Effects Support
B. 2,4-Hexadienoic acid, (E,E)- (CAS RN (HPV2), 40 CFR 799.5087. Documents and Drinking Water Health
110–44–1). 3. Test Data Received: The following Advisories for Cyanobacterial Toxins;
II. Federal Register Publication listing describes the nature of the test and a Support Document Containing
Requirement data received. The test data will be Recommendations for Managing
added to the docket for the applicable Cyanotoxins in Drinking Water
Section 4(d) of TSCA (15 U.S.C. TSCA section 4 test rule and can be
2603(d)) requires EPA to publish a found by referencing the docket ID AGENCY: Environmental Protection
notice in the Federal Register reporting number provided. EPA reviews of test Agency (EPA).
the receipt of test data submitted data will be added to the same docket ACTION: Notice of availability.
pursuant to test rules promulgated upon completion.
under TSCA section 4 (15 U.S.C. 2603). Aquatic Toxicity (Daphnia) (C1). The SUMMARY: The Environmental Protection
docket ID number assigned to this data Agency (EPA) announces the release of
III. Docket Information Ten-Day Health Advisories (HAs) for
is EPA–HQ–OPPT–2007–0531.
A docket, identified by the docket two cyanobacterial toxins, microcystins
identification (ID) number EPA–HQ– B. 2,4-Hexadienoic acid, (E,E)- (CAS RN and cylindrospermopsin. EPA also
OPPT–2013–0677, has been established 110–44–1). announces the release of Health Effect
for this Federal Register document that 1. Chemical Uses: Sorbic acid is a Support Documents (HESDs) for three
announces the receipt of data. Upon mold and yeast inhibitor, mainly used cyanobacterial toxins: Microcystins,
EPA’s completion of its quality in foods, animal feeds, tobacco, cylindrospermopsin, and anatoxin-a.
assurance review, the test data received cosmetics, and pharmaceuticals, as well The HESDs constitute a comprehensive
will be added to the docket for the as in packing materials for these review of the published literature on the
TSCA section 4 test rule that required substances and in other products that chemical and physical properties of
the test data. Use the docket ID number come in contact with human or animal these toxins, the toxin synthesis and
provided in Unit IV. to access the test skin. As a food preservative, sorbic acid environmental fate, occurrence and
data in the docket for the related TSCA is used to reduce the total number of exposure information, and health
section 4 test rule. viable bacteria and double the effects. The HESDs are used to develop
The docket for this Federal Register refrigerated shelf life for fresh poultry. HAs. Based on the reported occurrence,
document and the docket for each This chemical is also used as an toxicology, and epidemiology data, EPA
related TSCA section 4 test rule is intermediate in plasticizers and found there are adequate data to
available electronically at http:// lubricants, to impregnate polyethylene develop HAs for microcystins and
www.regulations.gov or in person at the wrappers for raw farm products, to cylindrospermopsin, but inadequate
asabaliauskas on DSK5VPTVN1PROD with NOTICES

Office of Pollution Prevention and improve characteristics of drying oils, in data to develop an HA for anatoxin-a.
Toxics Docket (OPPT Docket), alkyd type coatings to improve gloss, EPA’s HAs provide states, drinking
Environmental Protection Agency and to improve milling characteristics of water utilities and the public with
Docket Center (EPA/DC), West William cold rubber. information on health effects of
Jefferson Clinton Bldg., Rm. 3334, 1301 2. Applicable Test Rule: Chemical microcystins and cylindrospermopsin,
Constitution Ave. NW., Washington, testing requirements for second group of analytical methods to test for
DC. The Public Reading Room is open high production volume chemicals cyanotoxins in water samples, and
from 8:30 a.m. to 4:30 p.m., Monday (HPV2), 40 CFR 799.5087. treatment technologies to remove

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34638 Federal Register / Vol. 80, No. 116 / Wednesday, June 17, 2015 / Notices

cyanobacterial toxins in drinking water. potential impacts on drinking water and cylindrospermopsin. It provides
Additionally, EPA announces a support the potential to affect human health. information and a framework that PWSs
document for states and utilities to and others (as appropriate) can consider
III. What are EPA’s Health Advisories?
assist them as they consider whether to inform their decisions on managing
and how to manage cyanobacterial Under the Safe Drinking Water Act, the risks from cyanotoxins to drinking
toxins in drinking water. The EPA may publish Health Advisories water.
recommendations in this document are (HAs) for contaminants that are not
Dated: June 10, 2015.
intended to assist public drinking water subject to any national primary drinking
Kenneth J. Kopocis,
systems (PWSs) manage the risks from water regulation. 42 U.S.C. 300 g–
1(b)(1)(F). EPA develops HAs to provide Deputy Assistant Administrator, Office of
cyanobacterial toxins in drinking water, Water.
including information and a framework information on the chemical and
physical properties, occurrence and [FR Doc. 2015–14936 Filed 6–16–15; 8:45 am]
that PWSs can consider in their
exposure, health effects, quantification BILLING CODE 6560–50–P
cyanotoxin risk management efforts.
FOR FURTHER INFORMATION CONTACT: For of toxicological effects, other regulatory
information regarding the HAs or standards, analytical methods, and
treatment technology for drinking water ENVIRONMENTAL PROTECTION
HESDs: Lesley D’Anglada, Office of AGENCY
Water, Health and Ecological Criteria contaminants. HAs describe
Division (4304T), Environmental concentrations of drinking water [EPA–HQ–OPP–2015–0276; FRL–9927–37]
Protection Agency, 1200 Pennsylvania contaminants at which adverse health
effects are not anticipated to occur over Draft Test Guidelines; Series 810—
Avenue NW., Washington, DC 20460;
specific exposure durations (e.g., one- Product Performance Test Guidelines;
telephone number: (202) 566–1125;
day, ten-days, several years, and a Notice of Availability and Request for
email address: danglada.lesley@epa.gov.
lifetime). HAs also contain a margin of Comments
For information regarding
recommendations for cyanotoxin safety to address database uncertainties. AGENCY: Environmental Protection
management in drinking water: Hannah HAs serve as informal technical Agency (EPA).
Holsinger, Office of Water, Office of guidance to assist federal, state and
ACTION: Notice.
Ground Water and Drinking Water local officials, as well as managers of
(4607M), Environmental Protection public or community water systems in SUMMARY: This notice announces the
Agency, 1200 Pennsylvania Avenue protecting public health when availability for comment of several 810
NW., Washington, DC 20460; telephone emergency spills or contamination series, non-binding, draft test guidelines
number: (202) 564–0403; email address: situations occur. They are not developed by the Office of Chemical
holsinger.hannah@epa.gov. regulations and should not be construed Safety and Pollution Prevention
as legally enforceable federal standards. (OCSPP). The test guidelines provide
SUPPLEMENTARY INFORMATION:
HAs may change as new information guidance on conducting testing by the
I. General Information becomes available. public and companies that are subject to
A. How can I get copies of this IV. Information on EPA’s Ten-Day EPA data submission requirements
document and other related Health Advisories for the under OCSPP’s major statutory
information? Cyanobacterial Toxins, mandates.
1. Electronic Access. You may access Cylindrospermopsin and Microcystins DATES: Comments must be received on
this Federal Register document Today, EPA is making available the or before August 17, 2015.
electronically from the Government HA values for the cyanobacterial toxins ADDRESSES: Submit your comments,
Printing Office under the ‘‘Federal microcystins and cylindrospermopsin. identified by docket identification (ID)
Register’’ listings at FDSys (http:// EPA recommends 0.3 micrograms per number EPA–HQ–OPP–2015–0276, by
www.gpo.gov/fdsys/browse/ liter for microcystins and 0.7 one of the following methods:
collection.action?collectionCode=FR). micrograms per liter for • Federal eRulemaking Portal: http://
The Health Effects Support Documents cylindrospermopsin as levels not to be www.regulations.gov. Follow the online
and the Health Advisories for the exceeded in drinking water for bottle- instructions for submitting comments.
cyanobacterial toxins are available on fed infants and young children of pre- Do not submit electronically any
EPA’s Web site at http://water.epa.gov/ school age. For school-age children information you consider to be
drink/standards/hascience.cfm. The through adults, the health advisory Confidential Business Information (CBI)
Recommendations for Public Water values for drinking water are 1.6 or other information whose disclosure is
Systems to Manage Cyanotoxins in micrograms per liter for microcystins restricted by statute.
Drinking Water document is available and 3 micrograms per liter for • Mail: OPP Docket, Environmental
on EPA’s Web site at http:// cylindrospermopsin. The HA values are Protection Agency Docket Center (EPA/
www2.epa.gov/nutrient-policy-data/ based on exposure for ten days. DC), (28221T), 1200 Pennsylvania Ave.
guidelines-and-recommendations. NW., Washington, DC 20460–0001.
V. Information on EPA’s Support • Hand Delivery: To make special
II. What are cyanobacterial toxins and Document To Assist States and Utilities arrangements for hand delivery or
how are they produced? in Managing Cyanobacterial Toxins delivery of boxed information, please
Algae and cyanobacteria are natural EPA also announces the release of a follow the instructions at http://
asabaliauskas on DSK5VPTVN1PROD with NOTICES

components of fresh water; however, cyanotoxin management document that www.epa.gov/dockets/contacts.html.
under favorable conditions, they can is a companion to the HAs for Additional instructions on commenting
rapidly multiply causing ‘‘blooms.’’ microcystins and cylindrospermopsin. or visiting the docket, along with more
Some cyanobacterial species can The document is intended to assist information about dockets generally, is
produce toxins (cyanotoxins) at levels PWSs that choose to develop system- available at http://www.epa.gov/
that may be of concern for human specific plans for evaluating their source dockets.
health. These cyanobacterial toxins are waters for vulnerability to FOR FURTHER INFORMATION CONTACT: For
of particular concern because of their contamination by microcystins and general information contact: Melissa

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Document Created: 2015-12-15 14:23:30
Document Modified: 2015-12-15 14:23:30

Category		Regulatory Information
Collection		Federal Register
sudoc Class		AE 2.7: GS 4.107: AE 2.106:
Publisher		Office of the Federal Register, National Archives and Records Administration
Section		Notices
Action		Notice of availability.
Contact		For information regarding the HAs or HESDs: Lesley D'Anglada, Office of Water, Health and Ecological Criteria Division (4304T), Environmental Protection Agency, 1200 Pennsylvania Avenue NW., Washington, DC 20460; telephone number: (202)
FR Citation		80 FR 34637