Product Composition/Additives
Products and Additives in compliance with 381.0065(4)(m), F.S.
US Environmental Protection Agency's Toxicity Bioassay [96 hr. LC50] Methodology (3051 kb pdf)
Methods for Measuring the Acute Toxicity of Effluents and Receiving Waters to Freshwater and Marine Organisms
Florida Law for Septic System Product Composition:
Chapter 381.0065(4)(m), Florida Statutes: No
product sold in the state for use in onsite sewage
treatment and disposal systems may contain any
substance in concentrations or amounts that would
interfere with or prevent the successful operation
of such system, or that would cause discharges from
such system to violate applicable water quality
standards. The department shall publish
criteria for products known or expected to meet the
conditions of this paragraph. In the event a
product does not meet such criteria, such product
may be sold if the manufacturer satisfactorily
demonstrates to the department that the conditions
Please submit all required information to:
Attn: Marcelo Blanco / Product Composition Review
Onsite Sewage Programs
Florida Department of Health
4052 Bald Cypress Way, Bin #A08
Tallahassee, FL 32399-1713
Questions on product composition or additive use or review should be
directed to Marcelo Blanco at (407) 316-4540 or by
contacting the Onsite Sewage Programs.
64E-6.0151, F.A.C., PRODUCT COMPOSITION
(1) Any onsite sewage treatment and disposal system
additive or drainfield conditioner or restorative product sold or used
in the state shall be in compliance with the requirements of s.
381.0065(4)(m), F.S. The following criteria shall be used in determining
product compliance.
(a) Use of the product shall not result
in violations of Surface Water Quality Rule 62-302.500, F.A.C., effective 5-15-2002, or Groundwater Quality Rules
62-520.400 and 62-520.420, F.A.C., effective 12-9-1996.
(b) The product's formula itself shall not exceed water quality
contaminant concentrations in s. 62-302.500, F.A.C., effective
5-15-2002, or ss. 62-520.400 and 62-520.420, F.A.C.,
effective 12-9-1996.
(c) The product shall contain no substance in concentrations or amounts
that would interfere with or prevent the successful operation of an
onsite sewage treatment and disposal system.
(2) If the Department determines an onsite sewage treatment and
disposal system additive or drainfield conditioner or restorative
product is not in compliance with the criteria in Rule 64E-6.0151,
F.A.C., the Department shall notify the product manufacturer of the
items in non-compliance. The product shall be allowed to be continued
for sale and use in Florida for a maximum of 90 days from date of
receipt of notification of violation. This is to allow the manufacturer
an opportunity to exhibit to the department that the product
satisfactorily complies with the conditions of s. 381.0065(4)(m), F.S.,
and this rule.
In attempting to demonstrate compliance with s. 381.0065(4)(m), F.S.,
and this rule, the manufacturer shall provide at a minimum the following
information:
(a) A listing of all physical, chemical, biological or
other agents which make up the additive, conditioner or restorative
and provide toxicity information for each component. This
information shall include trade names, chemical names, and
concentrations of all individual or complexed components and the
Material Safety Data Sheet (MSDS) for the product. Any trade secret
will be treated according to s. 381.83, F.S.
(b) A list of all known, expected, or possible reactions and
by-products resulting from use of the product including the effect
on bacteria, all standard contents of the tank, including sludge
layer; scum layer; fats, oils and greases, and the effects on
currently approved drainfield distribution systems.
(c) Test results from a State or EPA-certified laboratory
demonstrating that use of the additive, drainfield conditioner
or restorative product will not result in violations of surface
water or groundwater standards in s. 64E-6.0151, F.A.C. Tests shall
be conducted on the product as sold and the test results shall
include:
1. Acute Definitive Toxicity test [96 hour
LC50] according to EPA Methods for Measuring the Acute Toxicity of
Effluents and Receiving Waters to Freshwater and Marine Organisms
(EPA -821-R-02-012), October 2002, herein incorporated by reference,
for Pimephales promelas (fathead minnow) or any of the
following species: Ceriodaphnia dubia (daphnid),
Cyprinella leedsi (bannerfin shiner), Daphnia pulex and
Daphnia magna (daphnids). The 96-hour LC50 shall be reported as
a concentration in mg/l or ml/l, and;
2. Chemical analysis showing the
concentrations of Volatile Organic Compounds [EPA 8260] to a minimum
detection level of 0.5 ug/L (ppb).
(d) A description of the anticipated use of the product in onsite
sewage treatment and disposal systems. Where and how the product is
to be applied, any exceptions to application guidelines, the
frequency of applications, who is allowed to perform the
applications, and the amount and concentration of product per
application shall be included in the product description. When the
product should not be used shall also be included in the
description. The information provided shall include the
manufacturer's recommended application rate of the product as it
appears on the product label. Unless the product label provides
other specifications, the department, for purposes of this
evaluation, assumes that the application rate will be applied to a
flow of 300 gallons per day into a 1000-gallon septic tank.
(e) All studies done on the use of the additive, conditioner or
restorative product which support or disputes the information
required in Rule 64E-6.0151, F.A.C. and which demonstrates the
product will not harm public health or the environment and will not
impair system components and functioning. Monitoring reports and
data from systems in use shall be provided if available.
(f) A signed and dated certification by the manufacturer that
states: "I certify under penalty of law that these documents and all
attachments, to the best of my knowledge and belief, are true,
accurate and complete, and represent all available data for [name of
product or products]."
(g) Scientific documentation demonstrating claimed benefits
occurring due to the use of the product.
(3) If the department determines that the product does not comply
with the provisions of s. 381.0065(4)(m), F.S., the department shall
stop the sale of the product or take other actions deemed necessary to
preclude the sale and use of the non-compliant product.
Specific Authority 154.06, 381.0011, 381.006, 381.0065(4)(m), FS.
Law Implemented 154.01, 381.001, 381.0011, 381.0012, 381.0025,
381.006, 381.0061, 381.0065(4)(m), 381.00655, 381.0066, 381.0067,
386.041, FS. History New 3-22-00, 05-24-04.
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