ILLINOIS POLLUTION CONTROL BOARD
April 10, 1986
IN THE MATTER OF:
)
PROPOSAL OF APPLIED BIOCHEMISTS
)
TO AMEND THE ALGICIDE REGULATIONS
)
R84—4
AT
35
ILL. ADM. CODE 602.103 AND
)
(Deconsolidated
602.110
)
(from R84—19)
FINAL OPINION AND ORDER OF THE BOARD
(by 3. Marlin):
This matter comes before
the Board upon the filing of
a
proposal on December
14, 1983
and an amended proposal on January
10,
1984 by Applied Biochemists, Inc.
(Applied)
to amend 35
Ill.
Adm. Code 602.103.
This proceeding
is being deconsolidated from
another proceeding,
R84—19.
In R84—l9, Carus Chemical Company
(Carus)
had filed
a proposal
on May 23,
1984 to amend Section
602.103.
Both the Applied and Carus proposals were consolidated
for hearing by Hearing Officer Order
on June 8,
1984
after Board
discussion.
Merit hearings were held
in Springfield, Illinois on
July 24, 1984
and
in Chicago,
Illinois on July 31, 1984.
The
Illinois Department of Energy and Natural Resources on November
27,
1984
found that an economic impact study was not necessary
and stated that “the
cost of making
a formal study
is
economically unreasonable
in relation
to the value of the study
to the Board
in determining
the adverse economic impact of the
regulation.”
(November
27,
1984 Negative Declaration).
The
Economic and Technical Advisory Committee concurred
in this
finding on January 23, 1985.
A supplemental hearing called by
the Board
to address
informational deficiencies was held May 20,
1985
in DeKaib, Illinois.
The participants submitted additional
information after hearing.
The Illinois Environmental Protection
Agency (Agency) submitted comments on October
7, 1985.
With
those comments,
the Agency proposed that not only should Section
602.103
be amended but that Section 602.110
be amended
as well by
deleting the words “copper sulfate”
and adding
the words
“the
algicide.”
In its First Notice Opinion and Order dated November
7,
1985,
the Board proposed
to adopt amendments
to
35
Ill. Adm. Code
602.103 and 602.110.
First notice of the proposed
rules was
published
at
9
Ill. Reg.
18328 on December
2,
1985.
Other than
the Administrative Code Unit,
no other comments were received
during first notice.
The second notice period began
on January
23,
1986 and terminated on March 10, 1986.
Motion
On March 7, 1986, Applied filed
a letter which
the Board
construes as a motion for reconsideration of the Board’s First
Notice Opinion and Order
and likewise the Second Notice Order.
69-199
2
In
re: Algicide Chemicals, R84—4,19 consolidated
(November 7,
1985; January 23,
1986).
Applied asserts both procedural and
substantive error
by the Board.
Procedurally, Applied asserts that
it did not receive
a copy
of the Board’s First Notice Opinion and Order
and first learned
of the Board’s first notice decision when
it received
a copy of
the Second Notice Order.
Applied contacted the hearing officer
and asserts that “he acknowledged
a possible oversight....”
The hearing officer’s attempts to check
for
receipt of the
first notice decision by those on the notice list were
inconclusive.
The participants, save Applied, all had received
copies of the first notice decision.
Others on the notice list,
who had no regular filing system for Board opinions, could not
say whether
they had received copies
or not.
However,
in order
to prevent any prejudice due
to mail system deficiencies,
Applied’s motion for reconsideration is granted.
The Board on
its own motion
is deconsolidating this from R84—19.
Substantively, Applied reargues
the merits
of
the case and
asserts that the record does not show triethanolamine as
a risk
to human health
and that the issue
of
its mutagenicity and
carcinogenicity have been distorted.
Applied,
however, fails
to
provide the Board with any new information
so as
to warrant the
Board granting relief to Applied or scheduling another
hearing in
this matter.
The Board’s decisions denying
relief to Applied
at first and
second notice
are hereby affirmed.
Should Applied wish to pursue
registration of
its compounds in Illinois
it may file another
request
for regulatory relief.
The rationale behind the First
Notice Opinion as
it pertains
to Applied
is adopted here and
is
set forth.
Discussion
The current algicide permit section 602.103 allows
the use
of only copper
sulfate
in treating algae problems
in bodies of
water
used as public water supplies.
Applied requests that the
regulations be modified
to allow the use of other products for
this purpose.
Applied’s original proposal would amend the
section
to include all algicides registered with the USEPA
for
use
in potable water.
Its amended proposal narrowed that scope
to
include only copper sulfate,
copper carbonate (malachite),
copper monoethanolamine
and copper triethanolamine compounds.
Applied’s two copper ethanolamine products are liquid Cutrine—
Plus and granulated Cutrine—Plus.
These are registered with the
USEPA pursuant
to the Federal Insecticide, Fungicide and
Rodenticide Act
(FIFRA,
7 U.S.C.
Sl36 et seq.,
1982)
for
use
in
bodies
of water
that are potable water supply sources.
(Reg.
No’s
8959—1OAA and 8959—12AA).
They are also registered with the
Illinois Department
of Agriculture
(as of December
28,
1983;
Applied Exhibit
20) pursuant
to the Illinois Pesticide Act
(IPA)
69-200
3
Ill.
Rev.
Stat. 1985,
ch.
5,
par.
801
et
seq.
These are chelated
copper compounds which
use ethanolamine complexes to keep
otherwise insoluble copper carbonate
in solution
(JR.
30,
31)1.
This results
in
a rather uniform copper concentration throughout
the water
(App.
Exhs.
16,
9,
13,
14).
The liquid form contains
nine percent elemental copper
(0.909 lbs./gal
Cu).
The
granulated form contains
3.7 percent active copper material
(App.
Exh.
14, JR.
15).
The record does not support the proposal to amend sections
602.103 and 602.110 to encompass those potable water supply
algicides registered with the USEPA for use
in Illinois.
In
order
to incorporate algicides registered with the USEPA pursuant
to 40 C.F.R. Part 162
(1984), the Board
is statutorily mandated
to have on file
a list of
those chemicals.
(Ill.
Rev.
Stat.
1985,
ch.
127, par. 1006.02, 35
Ill.
Adm. Code 100.385).
The
Board attempted
to obtain the list of algicides approved
for use
in potable water supplies from the USEPA.
It was not possible
to
secure
a complete listing.
The USEPA
itself does not have such
a
listing available for distribution
to the public.
(Board
exhibits
1,
2,
5,
6,
7,
and
8
as well
as the Hearing Officer
Report of March
1,
1985 document the difficulties encountered
during the attempt).
The Board
notes
the USEPA has been mandated by Congress to
review all algicides currently registered with it and
to
reregister
those that merit reregistration based on the latest
scientific data
7
U.S.C.
l36a(g)
(P.L.
95—396 eff. 9—30—
1978)).
The USEPA has not yet been able
to complete this
task.
There
is no evidence
in the record
to show that the
products of Applied have been reregistered
(See App.
Exh. 1).
Based on the record before
it, the Board declines to
incorporate
all potable water supply algicides registered with
the USEPA.
It will,
however,
incorporate individual chemical
compounds where the record contains sufficient information to
justify such action.
Copper Carbonate
(Malachite)
Applied, while proposing copper carbonate
as an algicide,
provided
no
information on
it.
The Agency in
its comments stated
that beq~usemalachite
is “insoluble with
a solubility factor
of
1
x 10”
and because
it does not possess any algicidal
properties,
it should
not be included
in the list of acceptable
algicides.”
(Ag. Comments, October
4,
1985).
Because of the
lack of any data supporting
the inclusion
of malachite, the Board
will not include it
as a public water supply algicide.
1
JR.
refers
to the transcript of the July 1984 hearings which
is
consecutively paginated.
MR.
refers to the May 1985 hearing
transcript.
69-201
4
Copper Monoethanolamine/Triethanolamine
Both products of Applied contain copper
in the form of mixed
copper—ethanolamine complexes.
Some of the breakdown products
of
Cutrine—Plus
include diethanolamine, monoethanolamine, ammonia,
acetic
acid, hydroxyacetic acid, glyoxal, glyoxylic acid, oxalic
acid,
formaldehyde gas and
formic acid.
Cutrine—Plus
is
a slight
skin irritant and
is moderately toxic
if swallowed.
It
is less
corrosive than copper sulfate.
Toxicological data show Cutririe—Plus
to be “generally
nontoxic
to fish and wildlife at recommended dosages,” although
“trout.
.
.
and certain other sensitive fish species may be
adversely affected
in very soft water (below 50 ppm of CaCo3).”
(App. Exh.
13).
Toxicity data for the bluegill sunfish
arid
for
the fathead minnow
(Pimephales promelas) appear
in Exhibits
11
and 17 while data on oral dose, single skin penetration, single
inhalation, primary skin irritation and eye
injury from animal
studies appear
in Applied Exhibit 12.
At
45 Fed. Reg.
53478
(August 12,
1980),
the USEPA mentions
that
it was concerned with the presence of 2.1 ppm of N—
nitrosodiethanolamine
in an original Applied formulation “since
80 percent of known N—nitrosoamine compounds have been shown to
be carcinogenic
in
a variety of species.”
(App. Exh.
7).
The
formulation was revised by Applied and now contains less than
1/ppm of N—nitrosodiethanolaminé which represents a risk level
acceptable
to the USEPA.
Id.
Prior
to the May 20 hearing, the Board raised
the question
of the possible mutagenicity and carcinogenicity of
triethanolamine
(TREA).
A scientific paper
on that topic by
Hoshino and Tanooka was placed
in the record
(Board Exh.
4).
The
researchers reported that mice fed on a diet including TREA
developed
tumors and that TREA in combination with
sodium nitrite
caused mutations
in bacteria.
The Board
retained Dr. William Hallenbeck, who has done
research
involving animal toxicology and human health effects,
to
evaluate the Tanooka paper.
He pointed out that the controls
used
in the test made it impossible
to conclude with certainty
that TREA caused the tumors.
He also stated that,
“a stable and
direct,
but unidentified, mutagen was found under
test conditions
which approached normal physiological parameters”
(MR.
16 and
17).
In answer
to
a question he replied,
“...xny overall
conclusion about TREA is that
at this point you could only go so
far
as
to characterize
it as a potential
animal carcinogen and,
therefore,
a potential human carcinogen”
(MR.
26).
Regarding
mutagenicity
he pointed out
that the Tanooka paper reported
a
four to five—fold increase
in mutagenicity for the combination of
TREA and sodium nitrite over sodium nitrite alone.
He also
stated that sodium nitrite
is common
in the human diet
(MR.
56
and 57).
69-202
5
In response
to the Tanooka paper, Applied presented two
letters critical of the paper
and entered
a paper
by Inone
et.
al. which considered
the mutagenicity of TREA (Applied Exh.
25).
This study found
no evidence that TREA by itself was
mutagenic.
It also suggested further study to determine the
exact
cause of the tumors reported
by Tanooka.
Applied’s Exhibit
9 which was
introduced at the July
24,
1984 hearing stated:
In
an
effort
to
find
any
and
all
available
references
on
chronic
data
on
monoethanolamine
and
triethanolamine
APPLIED
BIOCHEMISTS,
INC.
contacted
the
environmental
and
toxicology
branches
of
the
ethanolarnine
manufacturers
and
suppliers,
DOW
CHEMICAL,
UNION
CARBIDE,
OLIN
CORPORATION,
TEXACO
INC.
and
its subsidiary JEFFERSON CHEMICAL.
Based
on
our
efforts,
there
apparently
is
no
chronic
data
on
ethanolamines.
However,
these
contacts
yielded
significant
information
and
insight
into
ethanolamines, their biodegradation and toxicology.
No mention was made of the Tanooka paper
or
of the Inone paper,
which were published
in 1978 and 1982 respectively.
Applied’s
representative said at hearing that Applied was not informed of
the Tanooka paper
by
the TREA m~nufacturersand first learned
of
it
in the hearing officer order.
He also indicated that the
information had not been supplied
to the USEPA during
the Federal
registration process
(MR. 69).
Applied Exhibit 10 lists
the expected concentration of TREA
in
treated water
as between 0.48 ppm and 2.4 ppm
(see MR.
75 for
correction).
Applied gave no data
as
to how long TREA persisted
in
the body of water
after treatment and
in what concentration
(MR.
66).
The USEPA approved Cutrine and Cutrine—Plus
for use
in
public water supplies and the Illinois EPA has recommended that
they be approved
in Illinois.
The Board notes that Federal
approval was based largely upon information supplied
by Applied,
who
in turn relied on data provided by TREA suppliers.
The
Applied products have not yet been reregistered by the USEPA.
The Tanooka paper
indicates that TREA is a possible
carcinogen.
The controls
in that study were inadequate
to
determine whether TREA or TREA in combination with the heated
diet,
or some other combination of factors caused the reported
tumors.
Applied’s rebuttal
of the Tanooka paper failed
to dispel
the concerns raised.
The questions raised can best
be addressed
by an experiment with proper controls.
Regarding mutagenicity,
there
is reason
to believe that TREA
in conjunction with sodium
nitrite (which
is common
in the human diet)
has rnutagenic
properties.
In the absence
of additional substantive data,
the
69-203
6
Board believes
it
is unwise to place this chemical
in water
supplies which are consumed by the public.
The Board has no
reason
to conclude that the use of Applied’s products containing
TREA pose
a threat in other bodies of water.
The Board
finds that Applied has failed to demonstrate that
TREA can be applied to public water
supplies without posing
a
threat
to the public health.
Pursuant
to Section 27(b)
of the
Act, Applied’s data indicate that its product
is competitive with
the approved algicide
(JR. 90—99).
However, given
the
uncertainty over potential public health impacts of the product,
the Board cannot find that approving Applied’s petition will not
have an overall adverse economic
impact.
ORDER
The March
7, 1986 motion of Applied Biochemists, Inc.
for
reconsideration of the First Notice Opinion and Order and the
Second Notice Order
is granted.
The Board, however,
affirms its
decisions
at First and Second Notice and denies the requested
relief.
This docket
is hereby closed.
IT
IS SO ORDERED.
I,
Dorothy M. Gum,
Clerk of the Illinois Pollution Control
Board, hereby certify that
the above Opinion and Order was
adopted on
the /~i
day of
t~.-~’
,
1986,
by a vote
o f
~
~
I~. ~
Dorothy M.
unn,
Clerk
Illinois Pollution Control Board
69-204