Lignosulfonates; Exemptions from the Requirement of a Tolerance, 7912-7921 [05-2986]
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Federal Register / Vol. 70, No. 31 / Wednesday, February 16, 2005 / Proposed Rules
approval of a modified method using
the alternative kit.
B. Revised Methods
In the April 6, 2004, proposal, EPA
proposed changes to approved
analytical methods for use in Clean
Water Act and Safe Drinking Water Act
programs. The proposed changes
included methods that employ new
technologies and updated versions of
previously approved methods. Among
these changes, EPA proposed to approve
a number of ASTM International
methods, including ASTM Method
D6888–03 for determining available
cyanide in wastewater and drinking
water, ASTM Method D5673–02 for
determining various metals in
wastewater, and ASTM Method D4658–
92 for determining sulfide in
wastewater. Since publication of the
proposal, EPA has received revised
versions of these three methods and has
added them to the docket for public
comment: (1) D6888–04 Standard Test
Method for Available Cyanide with
Ligand Displacement and Flow Injection
Analysis (FIA) Utilizing Gas Diffusion
Separation and Amperometric Detection
(an update of proposed version: D6888–
03); (2) D5673–03 Standard Test Method
for Elements in Water by Inductively
Coupled Plasma—Mass Spectrometry
(an update of proposed version: D5673–
02); and (3) D4658–03 Standard Test
Method for Sulfide Ion in Water (and
update of proposed version: D4658–
92(1996)). Method D6888–04 contains a
new on-line sulfide removal procedure,
and Methods D5673–03 and D4658–03
have added standardized quality control
requirements and criteria. The methods
added to the Docket represent
refinements to the proposed versions,
and are not significant variations of
those versions. EPA may promulgate
some or all of these revised versions in
a final rule, and requests comment on
each. These methods are included in the
docket at OW–2003–0070–0348, 0349,
0350), respectively, and may be ordered
from ASTM International, 100 Barr
Harbor Drive, P.O. Box C700, West
Conshohocken, PA 19428–2959, United
States, or at https://www.astm.org.
In the April 6, 2004 proposal, EPA
proposed a method for the measurement
of Radium-226 and Radium-228 by
Gamma Spectroscopy in drinking water.
This method has been modified in
several ways and EPA seeks comment
on these modifications. The changes to
the method include the following:
correction of minor typographical
errors, minor editorial changes such as
the addition of chemical abstract
numbers for Radium-226 and Radium228; the addition of a description of the
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dangers regarding the use of diethyl
ether; minor changes to the equations
for activity, detection limit, and
uncertainty made as a result of public
comment; minor changes to the QC
section of the method; the addition of a
description of ‘‘mixed wastes’’ (i.e.,
waste that contains both hazardous
waste and radioactive waste); and the
addition of a reference to ASTM added
to describe Type 2 Reagent Water.
In the April 6, 2004 proposal, EPA
concluded that the proposed rule would
not have a significant economic impact
on a substantial number of small entities
(69 FR 18188). Adoption of the
refinement to the three methods for
which EPA is requesting comment today
would not change the Agency’s decision
to certify the proposal under the
Regulatory Flexibility Act. In addition,
as explained above, Methods D6888–04,
D5673–03 and D4658–03, like the
earlier proposed versions of these
methods, represent methods from
voluntary consensus standards bodies.
Section 12(d) of the National
Technology Transfer and Advancement
Act of 1995 directs EPA to use voluntary
standards in its regulatory activities as
discussed in more detail in the proposal
at 69 FR 18189–18190.
Dated: February 9, 2005.
Benjamin H. Grumbles,
Assistant Administrator, Office of Water.
[FR Doc. 05–2988 Filed 2–15–05; 8:45 am]
BILLING CODE 6560–50–P
ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Part 180
[OPP–2004–0413; FRL–7691–9]
Lignosulfonates; Exemptions from the
Requirement of a Tolerance
Environmental Protection
Agency (EPA).
ACTION: Proposed rule.
AGENCY:
SUMMARY: The Agency is proposing to
establish 44 exemptions from the
requirement of a tolerance for residues
of various lignosulfonate chemicals in
or on raw agricultural commodities
when used as inert ingredients in
pesticide formulations applied to
growing crops or to raw agricultural
commodities after harvest, or to animals
under the Federal Food, Drug, and
Cosmetic Act (FFDCA), as amended by
the Food Quality Protection Act of 1996
(FQPA). This regulation eliminates the
need to establish a maximum
permissible level for residues of these
lignosulfonate chemicals.
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Comments, identified by docket
identification (ID) number OPP–2004–
0413, must be received on or before
April 18, 2005.
ADDRESSES: Submit your comments,
identified by docket ID number OPP–
2004–0413, by one of the following
methods:
• Federal eRulemaking Portal: https://
www.regulations.gov/. Follow the online instructions for submitting
comments.
• Agency Website: https://
www.epa.gov/edocket/. EDOCKET,
EPA’s electronic public docket and
comment system, is EPA’s preferred
method for receiving comments. Follow
the on-line instructions for submitting
comments.
• E-mail: Comments may be sent by
e-mail to opp-docket@epa.gov,
Attention: Docket ID Number OPP–
2004–0413.
• Mail: Public Information and
Records Integrity Branch (PIRIB)
(7502C), Office of Pesticide Programs
(OPP), Environmental Protection
Agency, 1200 Pennsylvania Ave., NW.,
Washington, DC 20460–0001, Attention:
Docket ID Number OPP–2004–0413.
• Hand delivery: Public Information
and Records Integrity Branch (PIRIB),
Office of Pesticide Programs (OPP),
Environmental Protection Agency, Rm.
119, Crystal Mall #2, 1801 S. Bell St.,
Arlington, VA, Attention: Docket ID
Number OPP–2004–0413. Such
deliveries are only accepted during the
Docket’s normal hours of operation, and
special arrangements should be made
for deliveries of boxed information.
Instructions: Direct your comments to
docket ID number OPP–2004–0413.
EPA’s policy is that all comments
received will be included in the public
docket without change and may be
made available online at https://
www.epa.gov/edocket/, including any
personal information provided, unless
the comment includes information
claimed to be Confidential Business
Information (CBI) or other information
whose disclosure is restricted by statute.
Do not submit information that you
consider to be CBI or otherwise
protected through EDOCKET,
regulations.gov, or e-mail. The EPA
EDOCKET and the regulations.gov
websites are ‘‘anonymous access’’
systems, which means EPA will not
know your identity or contact
information unless you provide it in the
body of your comment. If you send an
e-mail comment directly to EPA without
going through EDOCKET or
regulations.gov, your e-mail address
will be automatically captured and
included as part of the comment that is
DATES:
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Federal Register / Vol. 70, No. 31 / Wednesday, February 16, 2005 / Proposed Rules
placed in the public docket and made
available on the Internet. If you submit
an electronic comment, EPA
recommends that you include your
name and other contact information in
the body of your comment and with any
disk or CD ROM you submit. If EPA
cannot read your comment due to
technical difficulties and cannot contact
you for clarification, EPA may not be
able to consider your comment.
Electronic files should avoid the use of
special characters, any form of
encryption, and be free of any defects or
viruses. For additional information
about EPA’s public docket visit
EDOCKET on-line or see the Federal
Register of May 31, 2002 (67 FR 38102)
(FRL–7181–7).
Docket: All documents in the docket
are listed in the EDOCKET index at
https://www.epa.gov/edocket/. Although
listed in the index, some information is
not publicly available, i.e., CBI or other
information whose disclosure is
restricted by statute. Certain other
material, such as copyrighted material,
is not placed on the Internet and will be
publicly available only in hard copy
form. Publicly available docket
materials are available either
electronically in EDOCKET or in hard
copy at the Public Information and
Records Integrity Branch (PIRIB), Rm.
119, Crystal Mall #2, 1801 S. Bell St.,
Arlington, VA. This Docket Facility is
open from 8:30 a.m. to 4 p.m., Monday
through Friday, excluding legal
holidays. The Docket telephone number
is (703) 305–5805.
FOR FURTHER INFORMATION CONTACT:
Princess Campbell, Registration
Division (7505C), Office of Pesticide
Programs, Environmental Protection
Agency, 1200 Pennsylvania Ave., NW.,
Washington, DC 20460–0001; telephone
number: (703) 308–8033; e-mail address:
campbell.princess@epa.gov.
SUPPLEMENTARY INFORMATION:
I. General Information
A. Does this Action Apply to Me?
You may be potentially affected by
this action if you are an agricultural
producer, food manufacturer, or
pesticide manufacturer. Potentially
affected entities may include, but are
not limited to:
• Crop production (NAICS code 111),
• Animal production (NAICS code
112)
• Food manufacturing (NAICS code
311)
• Pesticide manufacturing (NAICS
code 32532).
This listing is not intended to be
exhaustive, but rather provides a guide
for readers regarding entities likely to be
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affected by this action. Other types of
entities not listed in this unit could also
be affected. The North American
Industrial Classification System
(NAICS) codes have been provided to
assist you and others in determining
whether this action might apply to
certain entities. If you have any
questions regarding the applicability of
this action to a particular entity, consult
the person listed under FOR FURTHER
INFORMATION CONTACT.
your estimate in sufficient detail to
allow for it to be reproduced.
vi. Provide specific examples to
illustrate your concerns, and suggest
alternatives.
vii. Explain your views as clearly as
possible, avoiding the use of profanity
or personal threats.
viii. Make sure to submit your
comments by the comment period
deadline identified.
B. How Can I Access Electronic Copies
of this Document and Other Related
Information?
In addition to using EDOCKET
(https://www.epa.gov/edocket/), you may
access this Federal Register document
electronically through the EPA Internet
under the ‘‘Federal Register’’ listings at
https://www.epa.gov/fedrgstr/. A
frequently updated electronic version of
40 CFR part 180 is available on E-CFR
Beta Site Two at https://
www.gpoaccess.gov/ecfr/.
A. What Action is the Agency Taking?
C. What Should I Consider as I Prepare
My Comments for EPA?
1. Submitting CBI. Do not submit this
information to EPA through EDOCKET,
regulations.gov, or e-mail. Clearly mark
the part or all of the information that
you claim to be CBI. For CBI
information in a disk or CD ROM that
you mail to EPA, mark the outside of the
disk or CD ROM as CBI and then
identify electronically within the disk or
CD ROM the specific information that is
claimed as CBI. In addition to one
complete version of the comment that
includes information claimed as CBI, a
copy of the comment that does not
contain the information claimed as CBI
must be submitted for inclusion in the
public docket. Information so marked
will not be disclosed except in
accordance with procedures set forth in
40 CFR part 2.
2. Tips for preparing your comments.
When submitting comments, remember
to:
i. Identify the rulemaking by docket
ID number and other identifying
information (subject heading, Federal
Register date, and page number).
ii. Follow directions. The agency may
ask you to respond to specific questions
or organize comments by referencing a
Code of Federal Regulations (CFR) part
or section number.
iii. Explain why you agree or disagree;
suggest alternatives and substitute
language for your requested changes.
iv. Describe any assumptions and
provide any technical information and/
or data that you used.
v. If you estimate potential costs or
burdens, explain how you arrived at
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II. Background
The Agency is proposing to establish
44 tolerance exemptions for various
lignosulfonate chemicals. Currently,
there are seven tolerance exemptions for
lignosulfonate chemicals. In 40 CFR
180.910 and 180.930, the exemption
reads: Lignosulfonate, ammonium,
calcium, magnesium, potassium,
sodium, and zinc salts. The Agency
intends to remove this single
exemption, and split the exemption into
separate chemical entries. There are also
in 40 CFR 180.910 and 930, exemptions
for oxidized pine lignin, sodium salt
with a limitation of 2% in the
formulation. As part of the proposed
actions, the limitation will be removed.
The exemptions for pine lignin in 40
CFR 180.910 and 180.930 will be
revised to include the Chemical
Abstracts Service Registry Number (CAS
No.) and a different naming convention.
In 40 CFR 180.910 the exemption for
ethoxylated lignosulfonic acid, sodium
salt will be revised in a similar manner.
In part, this action is based on two
pesticide petitions (PP 6E4673 and
6E4674) from LignoTech USA Inc., 100
Hwy. 51 South, Rothschild, WI 54474.
LignoTech requested exemptions from
the requirement of a tolerance for sulfite
liquors and cooking liquors, spent,
oxidized; and lignosulfonic acid,
sodium salt, oxidized, when used as
inert ingredients in pesticide
formulations. The petitioner requested
that 40 CFR 180.1001(c) and (e) (newly
redesignated as 180.910 and 180.930) be
amended by establishing these
exemptions from the requirement of a
tolerance.
EPA on its own initiative, under
section 408(e) of FFDCA, 21 U.S.C.
346a(e), is proposing to amend several
existing tolerance exemptions and to
establish several new tolerance
exemptions for various lignosulfonate
chemicals on raw agricultural
commodities when used in pesticide
formulations as inert ingredients
(surfactants or related adjuvants to
surfactants) applied to growing crops, or
to raw agricultural commodities after
harvest and when applied to animals.
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The 22 lignosulfonate chemicals, (a total
of 44 exemptions), that the Agency is
proposing to exempt from the
requirement of a tolerance are listed in
the Table 1 of this unit.
TABLE 1.—LIGNIN AND LIGNOSULFONATE CHEMICALS PROPOSED FOR TOLERANCE EXEMPTION
Chemical
Chemical formula
CAS No.
Lignosulfonic acid
C213H246O88S64
8062–15–5
Lignosulfonic acid, ammonium salt
C213H258N4O88S4
8061–53–8
Lignosulfonic acid, calcium salt
C213H242Ca2O88S4
8061–52–7
Lignosulfonic acid, magnesium salt
C213H242Mg2O88S4
8061–54–9
Lignosulfonic acid, sodium salt
C213H242Na4O88S4
8061–51–6
Lignosulfonic acid, potassium salt
C213H242K4O88S4
37314–65–1
Lignosulfonic acid, zinc salt
C213H242O88S4Zn2
57866–49–6
Lignosulfonic acid, ammonium sodium salt
166798–73–8
Lignosulfonic acid, ammonium magnesium salt
123175–37–1
Lignosulfonic acid, ammonium calcium salt
12710–04–2
Lignosulfonic acid, calcium magnesium salt
55598–86–2
Lignosulfonic acid, calcium sodium salt
37325–33–0
Lignosulfonic acid, sodium salt sulfomethylated
C214H242Na6O94S6
68512–34–5
Lignin alkali reaction products with disodium sulfite and formaldehyde
C213H248Na2O83S2
105859–97–0
Lignin alkali reaction products with formaldehyde and sodium bisulfite
C213H248Na2O83S2
68512–35–6
Ethoxylated lignosulfonic acid, sodium salt
C217H250Na4O90S4
68611–14–3
Lignin, alkali, oxidized, sodium salt
C213H237Na5O81
68201–23–0
Lignin
9005–53–2
Lignin, alkali
C213H245Na6O76
8068–05–1
Lignosulfonic acid, sodium salt, polymer with HCHO and phenol
C229H256Na3O90S4
37207–89–9
Sulfite liquors and cooking liquid, spent, oxidized
C225H253CaNaO113S7
68514–09–0
Lignosulfonic acid, sodium salt oxidized
C212H230Na4O88S4
68855–41–4
B. What is the Agency’s Authority for
Taking this Action?
This proposed rule is issued under
section 408 of FFDCA, 21 U.S.C. 346a,
as amended by FQPA (Public Law 104–
170). Section 408(e) of FFDCA
authorizes EPA to establish, modify, or
revoke tolerances, or exemptions from
the requirement of a tolerance for
residues of pesticide chemicals in or on
raw agricultural commodities and
processed foods.
III. Human Health Assessment
Consistent with section 408(b)(2)(D)
of FFDCA, EPA has reviewed the
available scientific data and other
relevant information in support of this
action and considered its validity,
completeness and reliability, and the
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relationship of this information to
human risk. EPA has also considered
available information concerning the
variability of the sensitivities of major
identifiable subgroups of consumers,
including infants and children. The
nature of the toxic effects caused by
lignosulfonate chemicals are discussed
in this unit.
A. Description of Lignosulfonate
Materials
Lignin is an extremely complex
naturally occurring phenolic polymer
that is primarily made of three phenolic
alcohols: Coniferyl, p-coumaryl, and
synapyl alcohols. These alcohols are
cross-linked to each other via a variety
of different chemical bonds. The
structure of lignin is somewhat
undefined. However, it is lignin that
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supplies the strength and rigidity to the
cell wall of plants. Lignin is the gluelike substance that binds the cellulose
fibers together. The lignin group of
compounds makes up the second most
abundant class of chemicals found in
plants. Cellulose is the most abundant.
According to information available on
the internet (https://www.chem.vt.edu/
chem-dept/helm/3434WOOD/notes1/
lignin.html), the ratio of the alcohols
determines the rigidity or flexibility of
the plant’s cell wall. ‘‘p-Coumaryl
alcohol is a minor component of grass
and forage type lignins. Coniferyl
alcohol is the predominant lignin
monomer found in softwoods.....Both
coniferyl and sinapyl alcohols are the
building blocks of hardwood lignin.’’
The lignin content of softwoods are on
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the order of 26–32% and of hardwoods
20–28%.
To make pulp and paper, various
processes are used to release the
cellulose, by removing the lignin from
plant cells, by destroying the chemical
bonds within the lignin. These
processes produce by-products which
are different in composition from the
original lignin polymer. In one such
process lignin reacts with sulfur dioxide
to form lignosulfonic acid.
Lignosulfonates can also be produced as
the sodium, potassium, calcium,
magnesium, zinc, or ammonium salts.
Using other chemical processes
lignosulfonate chemicals that have been
oxidized or ethoxylated can be
manufactured.
rule to establish tolerance exemptions
for oxidized pine lignin, sodium salt
(CAS No. 68201–23–0). In that proposed
rule the Agency described its review
and evaluation of various toxicity data
as follows: ‘‘The toxicological data show
that pine lignin, sulfonated pine lignin
as well as oxidized pine lignin or
lignosulfonates are of very low acute
toxicity (LD50 > 2 to > 5 g/kg in
rats......Pine lignin is classified as
toxicity category IV in a skin irritation
and eye irritation studies.’’ The final
rule establishing the tolerance
exemption for oxidized pine lignin
published in the Federal Register of
June 19, 1996 (61 FR 31037) (FRL–
3575–9).
B. Previous Agency Action
On March 27, 1996, EPA’s OPP
published in the Federal Register (61
FR 13476) (FRL–5355–6) a proposed
C. Internet Search for Publicly Available
Information
The Agency through its Interagency
Agreement with the Department of
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Energy’s Oakridge National Laboratory
conducted an extensive literature
search. Over 20 publicly available
websites, such as International
Programme on Chemical Safety (IPCS),
National Toxicological Program (NTP),
National Library of Medicine’s
TOXNET, Agency for Toxic Substances
and Disease Registry (ATSDR), and
Organization for Economic Co-operation
and Development (OECD), were
searched using both names and CAS
Nos. as search terms. It should be noted
that these are reliable compilations of
toxicity data. The search revealed little
information for these compounds in the
public literature. Table 2 of this unit
summarizes the information that was
retrieved. All of the following studies
were conducted using lignosulfonic
acid, sodium salt.
TABLE 2.—TOXICITY DATA FOR LIGNOSULFONIC ACID, SODIUM SALT (CAS NO. 8061–51–6)
Species
Study type
Results
Rat/Wistar
16-Week oral toxicity
NOAEL = 2.83 male (M) 2.42 female (F) gram/kilogram/day (g/kg/day)
LOAEL = 10.02 (M) 9.99 (F) g/kg/day based on statistically significant
decreases in body weight, RBC (erythrocytes), Hb (hemoglobin), and
hematocrit; significantly significant increases in total leucocyte count;
absolute and relative liver, spleen, and kidney weights in males
Rat/Wistar
Acute oral toxicity in male and female rats
LD50 > 40 g/kg
Rabbit
21/28-Day dermal toxicity
non irritating to skin in rabbits
Guinea pig (albino)
Repeated dose toxicity (1–5 weeks)
NOAEL was not determined
LOAEL = 1.740 g/kg/day based on ulceration of the colon in 50% of test
animals
Salmonella
typhimurium
strains TA98,
TA100, TA1535,
TA1537
Gene mutation
Non-mutagenic—Ames with and without activation
D. Information from the Petitioner
TABLE 3.—TOXICITY INFORMATION—
Continued
The information submitted in the two
petitions (6E4673 and 6E4674) by
LignoTech consisted of the following:
Chemical description
Study
TABLE 3.—TOXICITY INFORMATION
Carboxylated
lignosulfonate, calcium salt
Acute oral rat; LD50
is greater than 5
g/kg
Oxidized
lignosulfonate, sodium salt
Acute oral rat; LD50
is greater than 5
g/kg
Oxidized
lignosulfonate, sodium salt
Skin irritation; not irritating
Oxidized
lignosulfonate, sodium salt
Eye irritation; not irritating
Chemical description
Study
Pine lignin, sodium
salt
Acute oral rat; LD50
is greater than 2
g/kg
Sulfonated pine
lignin, sodium salt
Acute oral rat; LD50
is greater than 2
g/kg
Oxidized pine lignin,
sodium salt
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is greater than 5
g/kg
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The petitioner supplied only the
information in this unit, not the studies
or source from which the information
was extracted. Therefore, the Agency
cannot review and evaluate any of this
information. According to the
petitioner, lignosulfonates are generally
recognized as having low aquatic, avian,
and mammalian toxicities. Sulfite
liquors and cooking liquors are the raw
materials obtained from the sulfite
pulping of wood chips, with the main
component of these liquors being
sodium lignosulfonate, a derivative of
the natural-occurring polymer, lignin.
E. Structure Activity Relationship (SAR)
Assessment
The Agency traditionally begins its
evaluation process for inert ingredients
by searching publicly available
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databases. However, the Agency
believes that for certain chemicals it is
possible to assess the chemical’s toxicity
with other evaluation tools which can
include expert scientific judgement.
Even if literature searches do not yield
much toxicity data, given these other
tools, the Agency believes that it is still
possible to determine a ‘‘reasonable
certainty of no harm.’’
SAR analysis is a useful tool for
predicting toxicity and thus identifying
chemicals which may present specific
risk concerns and/or for which the value
of generating additional data would be
low. This analysis utilizes the
chemical’s structural similarity to other
chemicals for which data are available.
A discussion on the SAT process in the
Office of Pollution Prevention and
Toxics (OPPT) follows.
SAR assessments have been
performed by OPPT for over 25 years.
Under section 5 of the Toxic Substances
Control Act (TSCA), the Agency must
make a determination to restrict the
manufacture or importation of the
chemical within 90 days of the
submission of a pre-manufacturing
notice (PMN). The Agency must make
either a ‘‘...may present an unreasonable
risk to human health or the
environment...’’ finding or show that the
chemical ‘‘....is or will be produced in
substantial quantities, and such
substance either enters or may
reasonably be anticipated to enter the
environment in substantial quantities or
there is or may be significant or
substantial human exposure to the
substance...’’. However, section 5 of
TSCA does not require any toxicity
testing as a prerequisite for submission
of PMNs. Thus, toxicological data are
usually not available for review by the
Agency. In response to the lack of
toxicity data, and the mandated time
frames, the Agency has relied on expert
assessments to predict a chemical’s
toxicity.
For human health, the SAR process
can be used to assess absorption and
metabolism, mutagenicity,
carcinogenicity, developmental and
reproductive effects, neurotoxicity,
system effects, immunotoxicity,
sensitization, and irritation. This is a
qualitative assessment using terms such
as good, not likely, poor, moderate, or
high. To judge the validity of these
assessments, EPA examined the method
in the Project on the Evaluation of
(Quantitative) Structure Activity
Relationships (EPA 743–R–94–001).
Given only chemical structure
information, the Structure Activity
Team (SAT) in OPPT assessed 140
chemicals using their SAR assessment
process. The results of their assessments
were then compared to the ‘‘base set’’
data that the European Union (EU) had
received on each chemical. The results
indicated that the SAR assessments
were ‘‘on target’’ 90% of the time for
aquatic toxicity, and roughly 80% of the
time for human health effects. For
human health, the approximately 20%
that were not ‘‘on target’’ were
overestimates.
The SAT consists of expert scientists
who evaluate the potential
environmental fate, human health, and
environmental hazards of these new
chemicals. The scientific disciplines
represented on the SAT are: Chemistry,
environmental fate, ecotoxicity,
absorption/metabolism, mutagenicity,
carcinogenicity, developmental/
reproductive toxicity, neurotoxicity,
acute toxicity, and subchronic/chronic
toxicity.
Thus, after an in-depth literature
search revealed that there was not
extensive information available on the
lignosulfonates, OPP decided to utilize
the SAT’s expertise to evaluate/identify
the potential risks to human health
posed by the lignosulfonates, and the
environmental fate, health, and
environmental hazards of the
lignosulfonates, while considering the
information on lignosulfonic acid,
sodium salt. The SAT process begins by
verifying the chemical identity and
structures of the requested chemicals
and then estimating (modeling) the
physical/chemical properties of the
chemicals, if measured data are not
available.
Table 4 of this unit contains an
excerpt of the information on the
physical/chemical properties which
were used by the SAT to make the
determination. (Information on all of the
physical/chemical properties
considered by the SAT is contained in
paper format only in EDOCKET OPP–
2004–0413).
TABLE 4.—COMPARISON OF CHEMICAL/PHYSICAL PROPERTIES FOR LIGNOSULFONIC ACID SODIUM SALT AND SODIUM SALT
OXIDIZED (OBTAINED FROM THE SAT)
Chemical
Physical state
acid,
sodium
11:18 Feb 15, 2005
Vapor pressure
Molecular weight
salt,
>500
>500
<0.000001
10,000
Solid
>500
>500
<0.000001
10,000
The information used by the SAT
indicate that these are high molecular
weight, polymeric-type materials. After
determining the physical /chemical
properties, the SAT divided the 16
chemicals into 3 groups. Group 1
consisted of: Lignosulfonic acid,
ammonium salt; lignosulfonic acid,
calcium salt; lignosulfonic acid,
magnesium salt; lignosulfonic acid,
sodium salt; and lignosulfonic acid,
potassium salt.
The SAR conclusions for Group 1 are
as follows:
Absorption is nil for all routes based
on the physical/chemical properties.
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Water solubility (g/
Liter (L))
Solid
Lignosulfonic acid, sodium salt
Lignosulfonic
oxidized
Boiling point
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There is concern for irritation and
possible corrosion to the GI
(gastorintestinal) tract based on data
provided for sodium lignosulfonate
(guinea pig 14–28 day oral drinking
water LOEL = 1.7 g/kg/day with colonic
ulceration. No pH values were provided
for the lignosulfonic acid or its salts;
therefore, SAT members made the
assumption that the free acid would
have a very low pH value and that the
salts could have high pH values
depending on the amount of and the
manner in which the counter-ion
reacted or complexed with the acid.
Based on this assumption there is a
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concern for irritation to skin, eyes, and
lungs. There is also concern for lung
toxicity if inhaled based on potential
lung overload for high molecular weight
polymers. The SAT determined that
Group 1 lignosulfonates are of lowmoderate concern for human health
effects.
Group 2 consisted of lignosulfonic
acid, zinc salt. The SAT’s human health
assessment for lignosulfonic acid, zinc
salt are identical to Group 1’s with the
following addition. The inclusion of
zinc in the lignosulfonate polymer
results in concerns for developmental
toxicity and immunotoxicity at high
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doses, as well as concerns for asthma
and mutagenicity. However, the SAT
determined that lignosulfonic acid, zinc
salt is also of low-moderate concern for
human health effects.
Group 3 consisted of: Lignin, alkali
reaction products with disodium sulfite
and formaldehyde; lignin, alkali
reaction products with formaldehyde
and sodium bisulfite;ethoxylated
lignosulfonic acid, sodium salt; lignin,
alkali oxidized, sodium salt; lignin,
alkali; lignosulfonic acid, sodium salt,
polymer with formaldehyde and phenol;
sulfite liquors and cooking liquors,
spent, oxidized; lignosulfonic acid,
sodium salt, oxidized; andlignosulfonic
acid. The SAT’s human health
assessment for this group of
lignosulfonate chemicals was identical
to the SAT determinations for Group 1.
F. Data obtained via the High
Production Volume (HPV) Challenge
Program
The test plan for spent pulping liquor
(CAS No. 66071–92–9) was submitted to
OPPT on January 29, 2001 by the
American Forest & Paper Association
(AF&PA). (See https://www.epa.gov/
chemrtk/afpa/c12936.pdf/) On February
21, 2003, the final data summary was
submitted. (See https://www.epa.gov/
chemrtk/afpa/c12936fds.pdf/) While
spent pulping liquor is not proposed for
tolerance exemption in this document,
it is noted that one of the chemicals
proposed for tolerance exemption is
spent liquors and cooking liquid, spent,
oxidized. AF&PA noted in their data
summary, that spent pulping liquor is
very alkaline in nature, with a pH
ranging from 11.5 to 13.5. The
composition varies, but includes
pulping chemicals, cellulose,
hemicellulose, and lignin. Given the
high pH, testing could be performed on
only very dilute solutions, so the only
toxicity testing described in the
submission are two mutagenicity tests.
The results of the bacterial reverse
mutation test indicated that spent
pulping liquor is non-mutagenic in that
test. In a chromosomal aberration assay
with Chinese hamster ovary cells (in
vitro), spent pulping liquor was
clastogenic with and without activation.
Concentrations of 2,500 ug/mL with
activation and 5,000 µg/mL without
activation were judged overtly toxic to
the cultures.
G. Conclusions
The toxicity data available to the
Agency indicate that the lignosulfonates
are of very low toxicity. The oral acute
LD50s supplied by the petitioner are all
greater than 2 g/kg. The toxicological
data located in the public literature is
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for sodium lignosulfonate. Repeated
dose studies retrieved from open
literature indicate NOAELs and LOAELs
expressed as g/kg/day instead of the
usual unit in most toxicity studies
reviewed by the Agency of milligram
(mg)/kg/day. There is some very
unsubstantiated information that
lignosufonate materials given to rats
before, during, and after mating at doses
as high as 1,500 mg/kg/day did not
cause adverse effects on reproduction or
offspring. But at a dose level of 500 mg/
kg/day there were histopathological
changes in the lymph nodes of the
mothers. Given the quality and quantity
of information available, OPP needed
additional information to complete its
assessment of the lignosulfonate
chemicals.
As a group, the SAR assessments did
not identify any concerns for
mutagenicity or carcinogenicity for the
lignosulfonate chemicals. Based on the
physical/chemical properties, and
particularly on the large molecular
weights of the lignosulfonate chemicals,
the SAT believes that when considered
as a group, the lignosulfonates are not
absorbed via any route. This is due to
the fact, that generally, polymer-type
materials such as lignosulfonates of
these higher molecular weights would
be poorly absorbed through the intact
gastrointestinal tract or through intact
human skin.
As a group, one of the health concerns
for lignosulfonate chemicals is for
inhalation to the deep lung (a lung
overload effect), which could occur if
lignosulfonate chemicals were to be
used either as a powder or as an aerosol.
Other concerns identified by the SAT
are for irritation to skin, eyes, and lungs,
which was based on the assumption that
some of these chemicals could have a
low pH and therefore display effects
consistent with those of an acid. The
lung and irritation effects are adequately
handled through acute end-product
testing to determine any needed
personal protective equipment.
The lignosulfonic acid, zinc salt was
judged to be of more concern than any
of the other lignosulfonate salts.
According to the SAT, the inclusion of
zinc can result in concerns for
developmental toxicity and
immunotoxicity at high doses, as well as
concerns for asthma and mutagenicity.
However, zinc is also a needed nutrient.
Counter-ions such as calcium,
potassium, sodium, magnesium, and
zinc are required for proper functioning
of human biological systems. Thus, the
human body does have an effective
means of processing them. Zinc is an
essential element in the nutrition of
man. It functions as an integral part of
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numerous enzymes. The daily intake for
an adult ranges from 14 to 20 mg/day.
The recommended dietary allowance
(RDA) for adult men and women is 15
mg/day; however, the amount of zinc
needed by the body changes throughout
life. The Food and Nutrition Board of
the United States evaluated zinc dietary
allowances and recommended zinc as
follows: 2 mg for infants 0.5 years, 5 mg
for 0.5–1.0 years, 10 mg for children 1–
10 years, 15 mg for men and women 11–
51+ years, 20 mg for pregnant women,
and 25 mg for lactating women.
Deficiencies of zinc can cause illness.
Given the incorporation of zinc into a
polymeric-type high molecular weight
chemical, which is then not wellabsorbed by the human body, it is
unlikely that the high doses of zinc at
which adverse effects are possible
would be reached. Without the concerns
for the zinc counter-ion, as a group the
SAT judged that there were no
structural similarities of lignosulfonate
chemicals to any known developmental
toxicants.
IV. Aggregate Exposures
In examining aggregate exposure,
section 408 of FFDCA directs EPA to
consider available information
concerning exposures from the pesticide
residue in food and all other nonoccupational exposures, including
drinking water from ground water or
surface water and exposure through
pesticide use in gardens, lawns, or
buildings (residential and other indoor
uses).
A. Dietary Exposure
Several of the lignosulfonates have
applications in food and animal feed
products. Monographs describing purity
requirements and analytical procedures
for both lignosulfonic acid, calcium salt
and lignosulfonic acid, sodium salt are
published in the Fourth Edition of the
Food Chemicals Codex. Various salts of
lignosulfonic acid have been approved
by FDA as secondary direct food
additives, components of adhesives,
components of paper and paperboard,
and adjuvants for glue. Lignosulfonate
chemicals can also be used as a
pelletizing agent or binder in processed
animal feed items. Therefore, animals
can consume lignosulfonates as part of
their feed mix, and then these animals
are consumed by humans. Thus, there is
on-going human dietary exposure.
B. Drinking Water
To assess the presence of the
lignosulfonate chemicals in drinking
water, two reviews are available. A
review performed by OPP determined
that the various salts of lignosulfonic
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acid are soluble to very highly water
soluble depending on the cation. Once
in water dissociation of the cation is
expected depending on pH. These
lignosulfonates are not expected to be
mobile in terrestrial environments,
moving equally with the water and
sediment phase to surface water.
Ground water migration is not likely.
Once in water, the dissociated cation
and anion are likely to remain in
dissolution. The available information
suggest that lignosulfonates may be
persistent in aquatic environment of low
microbial activity and much less
persistent in environments with ample
microbial activity.
The SAR assessment performed by
OPPT determined that as a group the
lignosulfonates were of low concern for
exposure via drinking water. Though
the time for complete aerobic
degradation is predicted to be months,
the lignosulfonates are strongly
adsorbed to soils and sediments due to
their high-molecular weights. This
strong binding minimizes the
availability of these chemicals for
migration to ground water supplies and
thus reduces the potential for residues
of lignosulfonates to be present in
drinking water.
C. Other Non-Occupational
Lignosulfonates have many uses in
industrial applications. According to the
Lignin Institute website, lignosulfonates
can be used as an adhesive (a binder),
a dispersant to prevent the clumping
and settling of undissolved particles in
suspensions, an emulsion stabilizer, and
as a sequestrant for water treatments for
boilers and cooling systems.
Lignosulfonates are used for dust
control and surface stabilization on
roads.
V. Cumulative Effects
Section 408(b)(2)(D)(v) of 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.’’
Unlike other pesticides for which EPA
has followed a cumulative risk approach
based on a common mechanism of
toxicity, EPA has not made a common
mechanism of toxicity finding for any of
the lignosulfonate chemicals. As a
group, the lignosulfonates do not appear
to produce any toxic metabolite
produced by other substances. For the
purposes of this tolerance action,
therefore, EPA has not assumed that any
of the lignosulfonate chemicals have a
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common mechanism of toxicity with
other substances. For 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 the policy statements
released by EPA’s OPP concerning
common mechanism determinations
and procedures for cumulating effects
from substances found to have a
common mechanism on EPA’s website
at https://www.epa.gov/pesticides/
cumulative/.
VI. Determination of Safety
The available data from the open
literature describes chemicals which
exhibit effects at doses that are in the
grams per kilogram per day.
Additionally, the Agency’s
understanding of the polymeric nature
of these chemicals indicates nil
absorption, and there is a finding of
low-moderate concern for human health
from the SAR assessments. Based on all
of the available information, EPA
concludes that these lignosulfonate
chemicals do not pose an appreciable
risk under reasonably foreseeable
circumstances. Accordingly, EPA finds
that there is a reasonable certainty that
no harm will result to the general
population, and to infants and children
from aggregate exposure to these
lignosulfonate chemicals.
Section 408 of FFDCA provides that
EPA shall apply an additional tenfold
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 unless EPA concluded that a
different margin of safety will be safe for
infants and children. The SAR
assessments did not indicate any
concerns for developmental toxicity for
the lignosulfonate chemicals, other than
for the zinc counter-ion. Given the
incorporation of zinc into a polymerictype high molecular weight chemical,
which is then not well-absorbed by the
human body, it is unlikely that the high
doses of zinc at which adverse effects
can occur would be reached. Due to the
expected low oral toxicity due to the nil
absorption of the lignosulfonates, a
safety factor analysis has not been used
to assess the risk. For the same reasons,
the additional tenfold safety factor for
the protection of infants and children is
unnecessary.
VII. Other Considerations
A. Endocrine Disruptors
FQPA requires EPA to develop a
screening program to determine whether
certain substances, including all
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pesticide chemicals (both inert and
active ingredients), ‘‘may have an effect
in humans that is similar to an effect
produced by a naturally occurring
estrogen, or such other endocrine
effect...’’ EPA has been working with
interested stakeholders to develop a
screening and testing program as well as
a priority setting scheme. As the Agency
proceeds with implementation of this
program, further testing of products
containing lignosulfonate chemicals for
endocrine effects may be required.
B. Analytical Method
An analytical method is not required
for enforcement purposes since the
Agency is proposing exemptions from
the requirement of a tolerance without
any numerical limitation.
C. Existing Tolerances
Currently, there are seven tolerance
exemptions for lignosulfonate
chemicals. In 40 CFR 180.910:
Ethoxylated lignosulfonic acid, sodium
salt; lignosulfonate, ammonium,
calcium, magnesium, potassium,
sodium, and zinc salts; oxidized pine
lignin, sodium salt; pine lignin . There
are also in 40 CFR 180.930:
Lignosulfonate, ammonium, calcium,
magnesium, potassium, sodium, and
zinc salts; oxidized pine lignin, sodium
salt; and pine lignin. The Agency is
proposing to revise these tolerances.
D. International Tolerances
The Agency is not aware of any
country requiring a tolerance for any of
the lignosulfonate chemicals nor have
any CODEX Maximum Residue Levels
(MRLs) been established for any food
crops at this time.
VIII. Conclusions
Based on the Agency’s review and
evaluation of the available information
on the toxicity of lignosulfonate
chemicals and considering the SAR
assessments, EPA concludes that there
is a reasonable certainty of no harm
from aggregate exposure to residues of
these 22 lignosulfonate chemicals. The
Agency finds that exempting these 22
lignosulfonate chemicals from the
requirement of a tolerance will be safe.
IX. Statutory and Executive Order
Reviews
This proposed rule establishes 32
exemptions from the requirement for a
tolerance under section 408(d) of
FFDCA. The Office of Management and
Budget (OMB) has exempted these types
of actions from review under Executive
Order 12866, entitled Regulatory
Planning and Review (58 FR 51735,
October 4, 1993). Because this proposed
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rule has been exempted from review
under Executive Order 12866 due to its
lack of significance, this proposed rule
is not subject to Executive Order 13211,
entitled Actions Concerning Regulations
That Significantly Affect Energy Supply,
Distribution, or Use (66 FR 28355, May
22, 2001). This proposed rule does not
contain any information collections
subject to OMB approval under the
Paperwork Reduction Act (PRA), 44
U.S.C. 3501 et seq., or impose any
enforceable duty or contain any
unfunded mandate as described under
Title II of the Unfunded Mandates
Reform Act of 1995 (UMRA) (Public
Law 104–4). Nor does it require any
special considerations under Executive
Order 12898, entitled Federal Actions to
Address Environmental Justice in
Minority Populations and Low-Income
Populations (59 FR 7629, February 16,
1994); or OMB review or any Agency
action under Executive Order 13045,
entitled Protection of Children from
Environmental Health Risks and Safety
Risks (62 FR 19885, April 23, 1997).
This action does not involve any
technical standards that would require
Agency consideration of voluntary
consensus standards pursuant to section
12(d) of the National Technology
Transfer and Advancement Act of 1995
(NTTAA), Public Law 104–113, section
12(d) (15 U.S.C. 272 note). The
Regulatory Flexibility Act (RFA) (5
U.S.C. 601 et seq.) generally requires an
agency to prepare a regulatory flexibility
analysis of any rule subject to notice
and comment rulemaking requirements
under the Administrative Procedure Act
or any other statute unless the agency
certifies that the rule will not have a
significant impact on a substantial
number of small entities. Small entities
include small businesses, small
organizations, and small governmental
organizations. After considering the
economic impacts of this proposed rule
on small entities, I certify that this
action will not have a significant
economic impact on a substantial
number of small entities. Establishing
an exemption from the requirement of a
pesticide tolerance (or, expanding and
consolidating a tolerance exemption, as
is proposed), is in effect, the removal of
a regulatory restriction on pesticide
residues in food and thus such an action
will not have any negative economic
impact on any entities, including small
entities. In addition, the Agency has
determined that this action will not
have a substantial direct effect on States,
on the relationship between the national
government and the States, or on the
distribution of power and
responsibilities among the various
levels of government, as specified in
Executive Order 13132, entitled
Federalism (64 FR 43255, August 10,
1999). Executive Order 13132 requires
EPA to develop an accountable process
to ensure ‘‘meaningful and timely input
by State and local officials in the
development of regulatory policies that
have federalism implications.’’ ‘‘Policies
that have federalism implications’’ is
defined in the Executive order to
include regulations that have
‘‘substantial direct effects on the States,
on the relationship between the national
government and the States, or on the
distribution of power and
responsibilities among the various
levels of government.’’ This proposed
rule directly regulates growers, food
processors, food handlers, and food
retailers, not States. This action does not
alter the relationships or distribution of
power and responsibilities established
by Congress in the preemption
provisions of section 408(n)(4) of
FFDCA. For these same reasons, the
Agency has determined that this
proposed rule does not have any ‘‘tribal
implications’’ as described in Executive
Order 13175, entitled Consultation and
Coordination with Indian Tribal
Governments (65 FR 67249, November
6, 2000). Executive Order 13175,
requires EPA to develop an accountable
process to ensure ‘‘meaningful and
timely input by tribal officials in the
development of regulatory policies that
have tribal implications.’’ ‘‘Policies that
have tribal implications’’ is defined in
the Executive order to include
regulations that have ‘‘substantial direct
effects on one or more Indian tribes, on
Inert ingredients
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11:18 Feb 15, 2005
Jkt 205001
the relationship between the Federal
Government and the Indian tribes, or on
the distribution of power and
responsibilities between the Federal
Government and Indian tribes.’’ This
proposed rule will not have substantial
direct effects on tribal governments, on
the relationship between the Federal
Government and Indian tribes, or on the
distribution of power and
responsibilities between the Federal
Government and Indian tribes, as
specified in Executive Order 13175.
Thus, Executive Order 13175 does not
apply to this proposed rule.
List of Subjects in 40 CFR Part 180
Environmental protection,
Administrative practice and procedure,
Agricultural commodities, Pesticides
and pests, Reporting and recordkeeping
requirements.
Dated: February 5, 2005.
Lois Rossi,
Director, Registration Division, Office of
Pesticide Programs.
Therefore, it is proposed that 40 CFR
chapter I be amended as follows:
PART 180—[AMENDED]
1. The authority citation for part 180
would continue to read as follows:
Authority: 21 U.S.C. 321(q), 346(a) and
371.
§ 180.910
[Amended]
2. Section 180.910 is proposed to be
amended by removing the following
entries from the table: Ethoxylated
lignosulfonic acid, sodium salt;
lignosulfonate, ammonium, calcium,
magnesium, potassium, sodium, and
zinc salts; oxidized pine lignin, sodium
salt; and pine lignin.
3. Section 180.910 is proposed to be
amended by adding alphabetically the
following entries to the table to read as
follows:
§ 180.910 Inert ingredients used pre- and
post-harvest; exemptions from the
requirement of a tolerance.
*
*
Limits
*
*
*
Lignin (CAS No.9005–53–2) .....................................................
Lignin, alkali (CAS No. 8068–05–1) ..........................................
Lignin, alkali, oxidized, sodium salt (CAS No. 68201–23–0) ....
Lignin alkali, reaction products with disodium sulfite and formaldehyde (CAS No. 105859–97–0).
Lignin alkali, reaction products with formaldehyde and sodium
bisulfite (CAS No. 68512–35–6).
Lignosulfonic acid (CAS . No. 8062–15–5) ...............................
Lignosulfonic acid, ammonium calcium salt (CAS No. 12710–
04–2).
PO 00000
Frm 00018
*
*
*
Uses
*
*
......................
......................
......................
......................
*
*
surfactant, related adjuvants of surfactants
Surfactant, related adjuvants of surfactants
Surfactant, related adjuvants of surfactants
Surfactant, related adjuvants of surfactants
......................
Surfactant, related adjuvants of surfactants
......................
......................
Surfactant, related adjuvants of surfactants
Surfactant, related adjuvants of surfactants
Fmt 4702
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7919
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Inert ingredients
Limits
Lignosulfonic acid, ammonium magnesium salt (CAS No.
123175–37–1).
Lignosulfonic acid, ammonium salt (CAS No. 8061–53–8) ......
Lignosulfonic acid, ammonium sodium salt (CAS No. 166798–
73–8).
Lignosulfonic acid, calcium magnesium salt (CAS No. 55598–
86–2).
Lignosulfonic acid, calcium salt (CAS No. 8061–52–7) ............
Lignosulfonic acid, calcium sodium salt (CAS No. 37325–33–
0).
Lignosulfonic acid, ethoxylated, sodium salt (CAS No. 68611–
14–3).
Lignosulfonic acid, magnesium salt (CAS No. 8061–54–9) .....
Lignosulfonic acid, potassium salt (CAS No. 37314–65–1) ......
Lignosulfonic acid, sodium salt (CAS No. 8061–51–6) ............
Lignosulfonic acid, sodium salt, oxidized (CAS No. 68855–
41–4).
Lignosulfonic acid, sodium salt, polymer with HCHO and phenol (CAS No. 37207–89–9).
Lignosulfonic acid, sodium salt, sulfomethylated (CAS No.
68512–34–5).
Lignosulfonic acid, zinc salt (CAS No. 57866–49–6) ................
*
*
*
Sulfite liquors and cooking liquid, spent, oxidized (CAS No.
68514–09–0).
*
*
*
*
*
§ 180.930
*
*
*
[Amended]
4. Section 180.930 is proposed to be
amended by removing the following
entries from the table: Lignosulfonate,
ammonium, calcium, magnesium,
Jkt 205001
Surfactant, related adjuvants of surfactants
......................
......................
Surfactant, related adjuvants of surfactants
Surfactant, related adjuvants of surfactants
......................
Surfactant, related adjuvants of surfactants
......................
......................
Surfactant, related adjuvants of surfactants
Surfactant, related adjuvants of surfactants
......................
Surfactant, related adjuvants of surfactants
......................
......................
......................
......................
Surfactant,
Surfactant,
Surfactant,
Surfactant,
......................
Surfactant, related adjuvants of surfactants
......................
Surfactant, related adjuvants of surfactants
related
related
related
related
adjuvants
adjuvants
adjuvants
adjuvants
*
*
*
Frm 00019
surfactants
surfactants
surfactants
surfactants
*
following entries to the table to read as
follows:
§ 180.930 Inert ingredients applied to
animals; exemptions from the requirement
of a tolerance.
*
Limits
PO 00000
of
of
of
of
...................... Surfactant, related adjuvants of surfactants
*
*
*
*
...................... Surfactant, related adjuvants of surfactants
*
*
*
*
Lignin (CAS No. 9005–53–2) ....................................................
Lignin, alkali (CAS No. 8068–05–1) ..........................................
Lignin, alkali, oxidized, sodium salt (CAS No. 68201–23–0) ....
Lignin alkali, reaction products with disodium sulfite and formaldehyde (CAS No. 105859–97–0).
Lignin alkali, reaction products with formaldehyde and sodium
bisulfite (CAS No. 68512–35–6).
Lignosulfonic acid (CAS No. 8062–15–5) .................................
Lignosulfonic acid, ammonium calcium salt (CAS No. 12710–
04–2).
Lignosulfonic acid, ammonium magnesium salt (CAS No.
123175–37–1).
Lignosulfonic acid, ammonium salt (CAS No. 8061–53–8) ......
Lignosulfonic acid, ammonium sodium salt (CAS No. 166798–
73–8).
Lignosulfonic acid, calcium magnesium salt (CAS No. 55598–
86–2).
Lignosulfonic acid, calcium salt (CAS No. 8061–52–7) ............
Lignosulfonic acid, calcium sodium salt (CAS No. 37325–33–
0).
Lignosulfonic acid, ethoxylated, sodium salt (CAS No. 68611–
14–3).
Lignosulfonic acid, magnesium salt (CAS No. 8061–54–9) .....
Lignosulfonic acid, potassium salt (CAS No. 37314–65–1) ......
Lignosulfonic acid, sodium salt (CAS No. 8061–51–6) ............
Lignosulfonic acid, sodium salt, oxidized (CAS No. 68855–
41–4).
Lignosulfonic acid, sodium salt, polymer with HCHO and phenol (CAS No. 37207–89–9).
Lignosulfonic acid, sodium salt, sulfomethylated (CAS No.
68512–34–5).
Lignosulfonic acid, zinc salt (CAS No. 57866–49–6) ................
11:18 Feb 15, 2005
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potassium, sodium, and zinc salts;
oxidized pine lignin, sodium salt; and
pine lignin.
5. Section 180.930 is proposed to be
amended by adding alphabetically the
Inert ingredients
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Federal Register / Vol. 70, No. 31 / Wednesday, February 16, 2005 / Proposed Rules
Inert ingredients
Limits
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Sulfite liquors and cooking liquid, spent, oxidized (CAS No.
68514–09–0).
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]]>Agencies
[Federal Register Volume 70, Number 31 (Wednesday, February 16, 2005)]
[Proposed Rules]
[Pages 7912-7921]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 05-2986]
-----------------------------------------------------------------------
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[OPP-2004-0413; FRL-7691-9]
Lignosulfonates; Exemptions from the Requirement of a Tolerance
AGENCY: Environmental Protection Agency (EPA).
ACTION: Proposed rule.
-----------------------------------------------------------------------
SUMMARY: The Agency is proposing to establish 44 exemptions from the
requirement of a tolerance for residues of various lignosulfonate
chemicals in or on raw agricultural commodities when used as inert
ingredients in pesticide formulations applied to growing crops oral commodities after harvest, or to animals under the
Federal Food, Drug, and Cosmetic Act (FFDCA), as amended by the Food
Quality Protection Act of 1996 (FQPA). This regulation eliminates the
need to establish a maximum permissible level for residues of these
lignosulfonate chemicals.
DATES: Comments, identified by docket identification (ID) number OPP-
2004-0413, must be received on or before April 18, 2005.
ADDRESSES: Submit your comments, identified by docket ID number OPP-
2004-0413, by one of the following methods:
Federal eRulemaking Portal: https://www.regulations.gov/.
Follow the on-line instructions for submitting comments.
Agency Website: https://www.epa.gov/edocket/. EDOCKET,
EPA's electronic public docket and comment system, is EPA's preferred
method for receiving comments. Follow the on-line instructions for
submitting comments.
E-mail: Comments may be sent by e-mail to opp-
docket@epa.gov, Attention: Docket ID Number OPP-2004-0413.
Mail: Public Information and Records Integrity Branch
(PIRIB) (7502C), Office of Pesticide Programs (OPP), Environmental
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-
0001, Attention: Docket ID Number OPP-2004-0413.
Hand delivery: Public Information and Records Integrity
Branch (PIRIB), Office of Pesticide Programs (OPP), Environmental
Protection Agency, Rm. 119, Crystal Mall 2, 1801 S. Bell St.,
Arlington, VA, Attention: Docket ID Number OPP-2004-0413. Such
deliveries are only accepted during the Docket's normal hours of
operation, and special arrangements should be made for deliveries of
boxed information.
Instructions: Direct your comments to docket ID number OPP-2004-
0413. EPA's policy is that all comments received will be included in
the public docket without change and may be made available online at
https://www.epa.gov/edocket/, including any personal information
provided, unless the comment includes information claimed to be
Confidential Business Information (CBI) or other information whose
disclosure is restricted by statute. Do not submit information that you
consider to be CBI or otherwise protected through EDOCKET,
regulations.gov, or e-mail. The EPA EDOCKET and the regulations.gov
websites are ``anonymous access'' systems, which means EPA will not
know your identity or contact information unless you provide it in the
body of your comment. If you send an e-mail comment directly to EPA
without going through EDOCKET or regulations.gov, your e-mail address
will be automatically captured and included as part of the comment that
is
[[Page 7913]]
placed in the public docket and made available on the Internet. If you
submit an electronic comment, EPA recommends that you include your name
and other contact information in the body of your comment and with any
disk or CD ROM you submit. If EPA cannot read your comment due to
technical difficulties and cannot contact you for clarification, EPA
may not be able to consider your comment. Electronic files should avoid
the use of special characters, any form of encryption, and be free of
any defects or viruses. For additional information about EPA's public
docket visit EDOCKET on-line or see the Federal Register of May 31,
2002 (67 FR 38102) (FRL-7181-7).
Docket: All documents in the docket are listed in the EDOCKET index
at https://www.epa.gov/edocket/. Although listed in the index, some
information is not publicly available, i.e., CBI or other information
whose disclosure is restricted by statute. Certain other material, such
as copyrighted material, is not placed on the Internet and will be
publicly available only in hard copy form. Publicly available docket
materials are available either electronically in EDOCKET or in hard
copy at the Public Information and Records Integrity Branch (PIRIB),
Rm. 119, Crystal Mall 2, 1801 S. Bell St., Arlington, VA. This
Docket Facility is open from 8:30 a.m. to 4 p.m., Monday through
Friday, excluding legal holidays. The Docket telephone number is (703)
305-5805.
FOR FURTHER INFORMATION CONTACT: Princess Campbell, Registration
Division (7505C), Office of Pesticide Programs, Environmental
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-
0001; telephone number: (703) 308-8033; e-mail address:
campbell.princess@epa.gov.
SUPPLEMENTARY INFORMATION:
I. General Information
A. Does this Action Apply to Me?
You may be potentially affected by this action if you are an
agricultural producer, food manufacturer, or pesticide manufacturer.
Potentially affected entities may include, but are not limited to:
Crop production (NAICS code 111),
Animal production (NAICS code 112)
Food manufacturing (NAICS code 311)
Pesticide manufacturing (NAICS code 32532).
This listing is not intended to be exhaustive, but rather provides
a guide for readers regarding entities likely to be affected by this
action. Other types of entities not listed in this unit could also be
affected. The North American Industrial Classification System (NAICS)
codes have been provided to assist you and others in determining
whether this action might apply to certain entities. If you have any
questions regarding the applicability of this action to a particular
entity, consult the person listed under FOR FURTHER INFORMATION
CONTACT.
B. How Can I Access Electronic Copies of this Document and Other
Related Information?
In addition to using EDOCKET (https://www.epa.gov/edocket/), you may
access this Federal Register document electronically through the EPA
Internet under the ``Federal Register'' listings at https://www.epa.gov/
fedrgstr/. A frequently updated electronic version of 40 CFR part 180
is available on E-CFR Beta Site Two at https://www.gpoaccess.gov/ecfr/.
C. What Should I Consider as I Prepare My Comments for EPA?
1. Submitting CBI. Do not submit this information to EPA through
EDOCKET, regulations.gov, or e-mail. Clearly mark the part or all of
the information that you claim to be CBI. For CBI information in a disk
or CD ROM that you mail to EPA, mark the outside of the disk or CD ROM
as CBI and then identify electronically within the disk or CD ROM the
specific information that is claimed as CBI. In addition to one
complete version of the comment that includes information claimed as
CBI, a copy of the comment that does not contain the information
claimed as CBI must be submitted for inclusion in the public docket.
Information so marked will not be disclosed except in accordance with
procedures set forth in 40 CFR part 2.
2. Tips for preparing your comments. When submitting comments,
remember to:
i. Identify the rulemaking by docket ID number and other
identifying information (subject heading, Federal Register date, and
page number).
ii. Follow directions. The agency may ask you to respond to
specific questions or organize comments by referencing a Code of
Federal Regulations (CFR) part or section number.
iii. Explain why you agree or disagree; suggest alternatives and
substitute language for your requested changes.
iv. Describe any assumptions and provide any technical information
and/or data that you used.
v. If you estimate potential costs or burdens, explain how you
arrived at your estimate in sufficient detail to allow for it to be
reproduced.
vi. Provide specific examples to illustrate your concerns, and
suggest alternatives.
vii. Explain your views as clearly as possible, avoiding the use of
profanity or personal threats.
viii. Make sure to submit your comments by the comment period
deadline identified.
II. Background
A. What Action is the Agency Taking?
The Agency is proposing to establish 44 tolerance exemptions for
various lignosulfonate chemicals. Currently, there are seven tolerance
exemptions for lignosulfonate chemicals. In 40 CFR 180.910 and 180.930,
the exemption reads: Lignosulfonate, ammonium, calcium, magnesium,
potassium, sodium, and zinc salts. The Agency intends to remove this
single exemption, and split the exemption into separate chemical
entries. There are also in 40 CFR 180.910 and 930, exemptions for
oxidized pine lignin, sodium salt with a limitation of 2% in the
formulation. As part of the proposed actions, the limitation will be
removed. The exemptions for pine lignin in 40 CFR 180.910 and 180.930
will be revised to include the Chemical Abstracts Service Registry
Number (CAS No.) and a different naming convention. In 40 CFR 180.910
the exemption for ethoxylated lignosulfonic acid, sodium salt will be
revised in a similar manner.
In part, this action is based on two pesticide petitions (PP 6E4673
and 6E4674) from LignoTech USA Inc., 100 Hwy. 51 South, Rothschild, WI
54474. LignoTech requested exemptions from the requirement of a
tolerance for sulfite liquors and cooking liquors, spent, oxidized; and
lignosulfonic acid, sodium salt, oxidized, when used as inert
ingredients in pesticide formulations. The petitioner requested that 40
CFR 180.1001(c) and (e) (newly redesignated as 180.910 and 180.930) be
amended by establishing these exemptions from the requirement of a
tolerance.
EPA on its own initiative, under section 408(e) of FFDCA, 21 U.S.C.
346a(e), is proposing to amend several existing tolerance exemptions
and to establish several new tolerance exemptions for various
lignosulfonate chemicals on raw agricultural commodities when used in
pesticide formulations as inert ingredients (surfactants or related
adjuvants to surfactants) applied to growing crops, or to raw
agricultural commodities after harvest and when applied to animals.
[[Page 7914]]
The 22 lignosulfonate chemicals, (a total of 44 exemptions), that the
Agency is proposing to exempt from the requirement of a tolerance are
listed in the Table 1 of this unit.
Table 1.--Lignin and Lignosulfonate Chemicals Proposed for Tolerance
Exemption
------------------------------------------------------------------------
Chemical Chemical formula CAS No.
------------------------------------------------------------------------
Lignosulfonic acid C213H246O88S64 8062-15-5
---------------------------------=======================================
---------------------------------=======================================
---------------------------------====================-------------------
---------------------------------=======================================
---------------------------------====================-------------------
---------------------------------=======================================
---------------------------------=======================================
---------------------------------====================-------------------
---------------------------------=======================================
---------------------------------====================-------------------
---------------------------------=======================================
---------------------------------=======================================
---------------------------------
---------------------------------
---------------------------------=======================================
---------------------------------
---------------------------------
---------------------------------
---------------------------------=======================================
---------------------------------=======================================
---------------------------------=======================================
------------------------------------------------------------------------
B. What is the Agency's Authority for Taking this Action?
This proposed rule is issued under section 408 of FFDCA, 21 U.S.C.
346a, as amended by FQPA (Public Law 104-170). Section 408(e) of FFDCA
authorizes EPA to establish, modify, or revoke tolerances, or
exemptions from the requirement of a tolerance for residues of
pesticide chemicals in or on raw agricultural commodities and processed
foods.
III. Human Health Assessment
Consistent with section 408(b)(2)(D) of FFDCA, EPA has reviewed the
available scientific data and other relevant information in support of
this action and considered its validity, completeness and reliability,
and the relationship of this information to human risk. EPA has also
considered available information concerning the variability of the
sensitivities of major identifiable subgroups of consumers, including
infants and children. The nature of the toxic effects caused by
lignosulfonate chemicals are discussed in this unit.
A. Description of Lignosulfonate Materials
Lignin is an extremely complex naturally occurring phenolic polymer
that is primarily made of three phenolic alcohols: Coniferyl, p-
coumaryl, and synapyl alcohols. These alcohols are cross-linked to each
other via a variety of different chemical bonds. The structure of
lignin is somewhat undefined. However, it is lignin that supplies the
strength and rigidity to the cell wall of plants. Lignin is the glue-
like substance that binds the cellulose fibers together. The lignin
group of compounds makes up the second most abundant class of chemicals
found in plants. Cellulose is the most abundant. According to
information available on the internet (https://www.chem.vt.edu/chem-
dept/helm/3434WOOD/notes1/lignin.html), the ratio of the alcohols
determines the rigidity or flexibility of the plant's cell wall. ``p-
Coumaryl alcohol is a minor component of grass and forage type lignins.
Coniferyl alcohol is the predominant lignin monomer found in
softwoods.....Both coniferyl and sinapyl alcohols are the building
blocks of hardwood lignin.'' The lignin content of softwoods are on
[[Page 7915]]
the order of 26-32% and of hardwoods 20-28%.
To make pulp and paper, various processes are used to release the
cellulose, by removing the lignin from plant cells, by destroying the
chemical bonds within the lignin. These processes produce by-products
which are different in composition from the original lignin polymer. In
one such process lignin reacts with sulfur dioxide to form
lignosulfonic acid. Lignosulfonates can also be produced as the sodium,
potassium, calcium, magnesium, zinc, or ammonium salts. Using other
chemical processes lignosulfonate chemicals that have been oxidized or
ethoxylated can be manufactured.
B. Previous Agency Action
On March 27, 1996, EPA's OPP published in the Federal Register (61
FR 13476) (FRL-5355-6) a proposed rule to establish tolerance
exemptions for oxidized pine lignin, sodium salt (CAS No. 68201-23-0).
In that proposed rule the Agency described its review and evaluation of
various toxicity data as follows: ``The toxicological data show that
pine lignin, sulfonated pine lignin as well as oxidized pine lignin or
lignosulfonates are of very low acute toxicity (LD50 > 2 to
> 5 g/kg in rats......Pine lignin is classified as toxicity category IV
in a skin irritation and eye irritation studies.'' The final rule
establishing the tolerance exemption for oxidized pine lignin published
in the Federal Register of June 19, 1996 (61 FR 31037) (FRL-3575-9).
C. Internet Search for Publicly Available Information
The Agency through its Interagency Agreement with the Department of
Energy's Oakridge National Laboratory conducted an extensive literature
search. Over 20 publicly available websites, such as International
Programme on Chemical Safety (IPCS), National Toxicological Program
(NTP), National Library of Medicine's TOXNET, Agency for Toxic
Substances and Disease Registry (ATSDR), and Organization for Economic
Co-operation and Development (OECD), were searched using both names and
CAS Nos. as search terms. It should be noted that these are reliable
compilations of toxicity data. The search revealed little information
for these compounds in the public literature. Table 2 of this unit
summarizes the information that was retrieved. All of the following
studies were conducted using lignosulfonic acid, sodium salt.
Table 2.--Toxicity Data for Lignosulfonic acid, Sodium Salt (CAS No.
8061-51-6)
------------------------------------------------------------------------
Species Study type Results
------------------------------------------------------------------------
Rat/Wistar 16-Week oral NOAEL = 2.83 male
toxicity (M) 2.42 female
(F) gram/kilogram/
day (g/kg/day)
LOAEL = 10.02 (M)
9.99 (F) g/kg/day
based on
statistically
significant
decreases in body
weight, RBC
(erythrocytes), Hb
(hemoglobin), and
hematocrit;
significantly
significant
increases in total
leucocyte count;
absolute and
relative liver,
spleen, and kidney
weights in males
-----------------------------------------------------
-----------------------------------------------------
--------------------------------
-----------------------------------------------------
------------------------------------------------------------------------
D. Information from the Petitioner
The information submitted in the two petitions (6E4673 and 6E4674)
by LignoTech consisted of the following:
Table 3.--Toxicity Information
------------------------------------------------------------------------
Chemical description Study
------------------------------------------------------------------------
Pine lignin, sodium salt Acute oral rat; LD50 is
greater than 2 g/kg
-------------------------------------------
-------------------------------------------
------------------------------------------------------------------------
------------------------------------------------------------------------
------------------------------------------------------------------------
------------------------------------------------------------------------
------------------------------------------------------------------------
The petitioner supplied only the information in this unit, not the
studies or source from which the information was extracted. Therefore,
the Agency cannot review and evaluate any of this information.
According to the petitioner, lignosulfonates are generally recognized
as having low aquatic, avian, and mammalian toxicities. Sulfite liquors
and cooking liquors are the raw materials obtained from the sulfite
pulping of wood chips, with the main component of these liquors being
sodium lignosulfonate, a derivative of the natural-occurring polymer,
lignin.
E. Structure Activity Relationship (SAR) Assessment
The Agency traditionally begins its evaluation process for inert
ingredients by searching publicly available
[[Page 7916]]
databases. However, the
Ageals it
is possible to assess the chemical's toxicity with other evaluation
tools which can include expert scientific judgement. Even if literature
searches do not yield much toxicity data, given these other tools, the
Agency believes that it is still possible to determine a `` reasonable
certainty of no harm.''
SAR analysis is a useful tool for predicting toxicity and thus
identifying chemicals which may present specific risk concerns and/or
for which the value of generating additional data would be low. This
analysis utilizes the chemical's structural similarity to other
chemicals for which data are available. A discussion on the SAT process
in the Office of Pollution Prevention and Toxics (OPPT) follows.
SAR assessments have been performed by OPPT for over 25 years.
Under section 5 of the Toxic Substances Control Act (TSCA), the Agency
must make a determination to restrict the manufacture or importation of
the chemical within 90 days of the submission of a pre-manufacturing
notice (PMN). The Agency must make either a ``...may present an
unreasonable risk to human health or the environment...'' finding or
show that the chemical ``....is or will be produced in substantial
quantities, and such substance either enters or may reasonably be
anticipated to enter the environment in substantial quantities or there
is or may be significant or substantial human exposure to the
substance...''. However, section 5 of TSCA does not require any
toxicity testing as a prerequisite for submission of PMNs. Thus,
toxicological data are usually not available for review by the Agency.
In response to the lack of toxicity data, and the mandated time frames,
the Agency has relied on expert assessments to predict a chemical's
toxicity.
For human health, the SAR process can be used to assess absorption
and metabolism, mutagenicity, carcinogenicity, developmental and
reproductive effects, neurotoxicity, system effects, immunotoxicity,
sensitization, and irritation. This is a qualitative assessment using
terms such as good, not likely, poor, moderate, or high. To judge the
validity of these assessments, EPA examined the method in the Project
on the Evaluation of (Quantitative) Structure Activity Relationships
(EPA 743-R-94-001). Given only chemical structure information, the
Structure Activity Team (SAT) in OPPT assessed 140 chemicals using
their SAR assessment process. The results of their assessments were
then compared to the ``base set'' data that the European Union (EU) had
received on each chemical. The results indicated that the SAR
assessments were ``on target'' 90% of the time for aquatic toxicity,
and roughly 80% of the time for human health effects. For human health,
the approximately 20% that were not ``on target'' were overestimates.
The SAT consists of expert scientists who evaluate the potential
environmental fate, human health, and environmental hazards of these
new chemicals. The scientific disciplines represented on the SAT are:
Chemistry, environmental fate, ecotoxicity, absorption/metabolism,
mutagenicity, carcinogenicity, developmental/reproductive toxicity,
neurotoxicity, acute toxicity, and subchronic/chronic toxicity.
Thus, after an in-depth literature search revealed that there was
not extensive information available on the lignosulfonates, OPP decided
to utilize the SAT's expertise to evaluate/identify the potential risks
to human health posed by the lignosulfonates, and the environmental
fate, health, and environmental hazards of the lignosulfonates, while
considering the information on lignosulfonic acid, sodium salt. The SAT
process begins by verifying the chemical identity and structures of the
requested chemicals and then estimating (modeling) the physical/
chemical properties of the chemicals, if measured data are not
available.
Table 4 of this unit contains an excerpt of the information on the
physical/chemical properties which were used by the SAT to make the
determination. (Information on all of the physical/chemical properties
considered by the SAT is contained in paper format only in EDOCKET OPP-
2004-0413).
Table 4.--Comparison of Chemical/Physical Properties for Lignosulfonic Acid Sodium Salt and Sodium Salt Oxidized (Obtained from the SAT)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Water solubility (g/
Chemical Physical state Boiling point Liter (L)) Vapor pressure Molecular weight
--------------------------------------------------------------------------------------------------------------------------------------------------------
Lignosulfonic acid, sodium salt Solid >500 >500 <0.000001 10,000
------------------------------------========================================================================
--------------------------------------------------------------------------------------------------------------------------------------------------------
The information used by the SAT indicate that these are high
molecular weight, polymeric-type materials. After determining the
physical /chemical properties, the SAT divided the 16 chemicals into 3
groups. Group 1 consisted of: Lignosulfonic acid, ammonium salt;
lignosulfonic acid, calcium salt; lignosulfonic acid, magnesium salt;
lignosulfonic acid, sodium salt; and lignosulfonic acid, potassium
salt.
The SAR conclusions for Group 1 are as follows:
Absorption is nil for all routes based on the physical/chemical
properties. There is concern for irritation and possible corrosion to
the GI (gastorintestinal) tract based on data provided for sodium
lignosulfonate (guinea pig 14-28 day oral drinking water LOEL = 1.7 g/
kg/day with colonic ulceration. No pH values were provided for the
lignosulfonic acid or its salts; therefore, SAT members made the
assumption that the free acid would have a very low pH value and that
the salts could have high pH values depending on the amount of and the
manner in which the counter-ion reacted or complexed with the acid.
Based on this assumption there is a concern for irritation to skin,
eyes, and lungs. There is also concern for lung toxicity if inhaled
based on potential lung overload for high molecular weight polymers.
The SAT determined that Group 1 lignosulfonates are of low-moderate
concern for human health effects.
Group 2 consisted of lignosulfonic acid, zinc salt. The SAT's human
health assessment for lignosulfonic acid, zinc salt are identical to
Group 1's with the following addition. The inclusion of zinc in the
lignosulfonate polymer results in concerns for developmental toxicity
and immunotoxicity at high
[[Page 7917]]
doses, as well as concerns for asthma and mutagenicity. However, the
SAT determined that lignosulfonic acid, zinc salt is also of low-
moderate concern for human health effects.
Group 3 consisted of: Lignin, alkali reaction products with
disodium sulfite and formaldehyde; lignin, alkali reaction products
with formaldehyde and sodium bisulfite;ethoxylated lignosulfonic acid,
sodium salt; lignin, alkali oxidized, sodium salt; lignin, alkali;
lignosulfonic acid, sodium salt, polymer with formaldehyde and phenol;
sulfite liquors and cooking liquors, spent, oxidized; lignosulfonic
acid, sodium salt, oxidized; andlignosulfonic acid. The SAT's human
health assessment for this group of lignosulfonate chemicals was
identical to the SAT determinations for Group 1.
F. Data obtained via the High Production Volume (HPV) Challenge Program
The test plan for spent pulping liquor (CAS No. 66071-92-9) was
submitted to OPPT on January 29, 2001 by the American Forest & Paper
Association (AF&PA). (See https://www.epa.gov/chemrtk/afpa/c12936.pdf/)
On February 21, 2003, the final data summary was submitted. (See http:/
/www.epa.gov/chemrtk/afpa/c12936fds.pdf/) While spent pulping liquor is
not proposed for tolerance exemption in this document, it is noted that
one of the chemicals proposed for tolerance exemption is spent liquors
and cooking liquid, spent, oxidized. AF&PA noted in their data summary,
that spent pulping liquor is very alkaline in nature, with a pH ranging
from 11.5 to 13.5. The composition varies, but includes pulping
chemicals, cellulose, hemicellulose, and lignin. Given the high pH,
testing could be performed on only very dilute solutions, so the only
toxicity testing described in the submission are two mutagenicity
tests. The results of the bacterial reverse mutation test indicated
that spent pulping liquor is non-mutagenic in that test. In a
chromosomal aberration assay with Chinese hamster ovary cells (in
vitro), spent pulping liquor was clastogenic with and without
activation. Concentrations of 2,500 ug/mL with activation and 5,000
[mu]g/mL without activation were judged overtly toxic to the cultures.
G. Conclusions
The toxicity data available to the Agency indicate that the
lignosulfonates are of very low toxicity. The oral acute
LD50s supplied by the petitioner are all greater than 2 g/
kg. The toxicological data located in the public literature is for
sodium lignosulfonate. Repeated dose studies retrieved from open
literature indicate NOAELs and LOAELs expressed as g/kg/day instead of
the usual unit in most toxicity studies reviewed by the Agency of
milligram (mg)/kg/day. There is some very unsubstantiated information
that lignosufonate materials given to rats before, during, and after
mating at doses as high as 1,500 mg/kg/day did not cause adverse
effects on reproduction or offspring. But at a dose level of 500 mg/kg/
day there were histopathological changes in the lymph nodes of the
mothers. Given the quality and quantity of information available, OPP
needed additional information to complete its assessment of the
lignosulfonate chemicals.
As a group, the SAR assessments did not identify any concerns for
mutagenicity or carcinogenicity for the lignosulfonate chemicals. Based
on the physical/chemical properties, and particularly on the large
molecular weights of the lignosulfonate chemicals, the SAT believes
that when considered as a group, the lignosulfonates are not absorbed
via any route. This is due to the fact, that generally, polymer-type
materials such as lignosulfonates of these higher molecular weights
would be poorly absorbed through the intact gastrointestinal tract or
through intact human skin.
As a group, one of the health concerns for lignosulfonate chemicals
is for inhalation to the deep lung (a lung overload effect), which
could occur if lignosulfonate chemicals were to be used either as a
powder or as an aerosol. Other concerns identified by the SAT are for
irritation to skin, eyes, and lungs, which was based on the assumption
that some of these chemicals could have a low pH and therefore display
effects consistent with those of an acid. The lung and irritation
effects are adequately handled through acute end-product testing to
determine any needed personal protective equipment.
The lignosulfonic acid, zinc salt was judged to be of more concern
than any of the other lignosulfonate salts. According to the SAT, the
inclusion of zinc can result in concerns for developmental toxicity and
immunotoxicity at high doses, as well as concerns for asthma and
mutagenicity. However, zinc is also a needed nutrient.
Counter-ions such as calcium, potassium, sodium, magnesium, and
zinc are required for proper functioning of human biological systems.
Thus, the human body does have an effective means of processing them.
Zinc is an essential element in the nutrition of man. It functions as
an integral part of numerous enzymes. The daily intake for an adult
ranges from 14 to 20 mg/day. The recommended dietary allowance (RDA)
for adult men and women is 15 mg/day; however, the amount of zinc
needed by the body changes throughout life. The Food and Nutrition
Board of the United States evaluated zinc dietary allowances and
recommended zinc as follows: 2 mg for infants 0.5 years, 5 mg for 0.5-
1.0 years, 10 mg for children 1-10 years, 15 mg for men and women 11-
51+ years, 20 mg for pregnant women, and 25 mg for lactating women.
Deficiencies of zinc can cause illness. Given the incorporation of zinc
into a polymeric-type high molecular weight chemical, which is then not
well-absorbed by the human body, it is unlikely that the high doses of
zinc at which adverse effects are possible would be reached. Without
the concerns for the zinc counter-ion, as a group the SAT judged that
there were no structural similarities of lignosulfonate chemicals to
any known developmental toxicants.
IV. Aggregate Exposures
In examining aggregate exposure, section 408 of FFDCA directs EPA
to consider available information concerning exposures from the
pesticide residue in food and all other non-occupational exposures,
including drinking water from ground water or surface water and
exposure through pesticide use in gardens, lawns, or buildings
(residential and other indoor uses).
A. Dietary Exposure
Several of the lignosulfonates have applications in food and animal
feed products. Monographs describing purity requirements and analytical
procedures for both lignosulfonic acid, calcium salt and lignosulfonic
acid, sodium salt are published in the Fourth Edition of the Food
Chemicals Codex. Various salts of lignosulfonic acid have been approved
by FDA as secondary direct food additives, components of adhesives,
components of paper and paperboard, and adjuvants for glue.
Lignosulfonate chemicals can also be used as a pelletizing agent or
binder in processed animal feed items. Therefore, animals can consume
lignosulfonates as part of their feed mix, and then these animals are
consumed by humans. Thus, there is on-going human dietary exposure.
B. Drinking Water
To assess the presence of the lignosulfonate chemicals in drinking
water, two reviews are available. A review performed by OPP determined
that the various salts of lignosulfonic
[[Page 7918]]
acid are soluble to very highly water soluble depending on the cation.
Once in water dissociation of the cation is expected depending on pH.
These lignosulfonates are not expected to be mobile in terrestrial
environments, moving equally with the water and sediment phase to
surface water. Ground water migration is not likely. Once in water, the
dissociated cation and anion are likely to remain in dissolution. The
available information suggest that lignosulfonates may be persistent in
aquatic environment of low microbial activity and much less persistent
in environments with ample microbial activity.
The SAR assessment performed by OPPT determined that as a group the
lignosulfonates were of low concern for exposure via drinking water.
Though the time for complete aerobic degradation is predicted to be
months, the lignosulfonates are strongly adsorbed to soils and
sediments due to their high-molecular weights. This strong binding
minimizes the availability of these chemicals for migration to ground
water supplies and thus reduces the potential for residues of
lignosulfonates to be present in drinking water.
C. Other Non-Occupational
Lignosulfonates have many uses in industrial applications.
According to the Lignin Institute website, lignosulfonates can be used
as an adhesive (a binder), a dispersant to prevent the clumping and
settling of undissolved particles in suspensions, an emulsion
stabilizer, and as a sequestrant for water treatments for boilers and
cooling systems. Lignosulfonates are used for dust control and surface
stabilization on roads.
V. Cumulative Effects
Section 408(b)(2)(D)(v) of 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.''
Unlike other pesticides for which EPA has followed a cumulative
risk approach based on a common mechanism of toxicity, EPA has not made
a common mechanism of toxicity finding for any of the lignosulfonate
chemicals. As a group, the lignosulfonates do not appear to produce any
toxic metabolite produced by other substances. For the purposes of this
tolerance action, therefore, EPA has not assumed that any of the
lignosulfonate chemicals have a common mechanism of toxicity with other
substances. For 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 the policy statements
released by EPA's OPP concerning common mechanism determinations and
procedures for cumulating effects from substances found to have a
common mechanism on EPA's website at https://www.epa.gov/pesticides/
cumulative/.
VI. Determination of Safety
The available data from the open literature describes chemicals
which exhibit effects at doses that are in the grams per kilogram per
day. Additionally, the Agency's understanding of the polymeric nature
of these chemicals indicates nil absorption, and there is a finding of
low-moderate concern for human health from the SAR assessments. Based
on all of the available information, EPA concludes that these
lignosulfonate chemicals do not pose an appreciable risk under
reasonably foreseeable circumstances. Accordingly, EPA finds that there
is a reasonable certainty that no harm will result to the general
population, and to infants and children from aggregate exposure to
these lignosulfonate chemicals.
Section 408 of FFDCA provides that EPA shall apply an additional
tenfold 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 unless EPA concluded that a different
margin of safety will be safe for infants and children. The SAR
assessments did not indicate any concerns for developmental toxicity
for the lignosulfonate chemicals, other than for the zinc counter-ion.
Given the incorporation of zinc into a polymeric-type high molecular
weight chemical, which is then not well-absorbed by the human body, it
is unlikely that the high doses of zinc at which adverse effects can
occur would be reached. Due to the expected low oral toxicity due to
the nil absorption of the lignosulfonates, a safety factor analysis has
not been used to assess the risk. For the same reasons, the additional
tenfold safety factor for the protection of infants and children is
unnecessary.
VII. Other Considerations
A. Endocrine Disruptors
FQPA requires EPA to develop a screening program to determine
whether certain substances, including all pesticide chemicals (both
inert and active ingredients), ``may have an effect in humans that is
similar to an effect produced by a naturally occurring estrogen, or
such other endocrine effect...'' EPA has been working with interested
stakeholders to develop a screening and testing program as well as a
priority setting scheme. As the Agency proceeds with implementation of
this program, further testing of products containing lignosulfonate
chemicals for endocrine effects may be required.
B. Analytical Method
An analytical method is not required for enforcement purposes since
the Agency is proposing exemptions from the requirement of a tolerance
without any numerical limitation.
C. Existing Tolerances
Currently, there are seven tolerance exemptions for lignosulfonate
chemicals. In 40 CFR 180.910: Ethoxylated lignosulfonic acid, sodium
salt; lignosulfonate, ammonium, calcium, magnesium, potassium, sodium,
and zinc salts; oxidized pine lignin, sodium salt; pine lignin . There
are also in 40 CFR 180.930: Lignosulfonate, ammonium, calcium,
magnesium, potassium, sodium, and zinc salts; oxidized pine lignin,
sodium salt; and pine lignin. The Agency is proposing to revise these
tolerances.
D. International Tolerances
The Agency is not aware of any country requiring a tolerance for
any of the lignosulfonate chemicals nor have any CODEX Maximum Residue
Levels (MRLs) been established for any food crops at this time.
VIII. Conclusions
Based on the Agency's review and evaluation of the available
information on the toxicity of lignosulfonate chemicals and considering
the SAR assessments, EPA concludes that there is a reasonable certainty
of no harm from aggregate exposure to residues of these 22
lignosulfonate chemicals. The Agency finds that exempting these 22
lignosulfonate chemicals from the requirement of a tolerance will be
safe.
IX. Statutory and Executive Order Reviews
This proposed rule establishes 32 exemptions from the requirement
for a tolerance under section 408(d) of FFDCA. The Office of Management
and Budget (OMB) has exempted these types of actions from review under
Executive Order 12866, entitled Regulatory Planning and Review (58 FR
51735, October 4, 1993). Because this proposed
[[Page 7919]]
rule has been exempted from review under Executive Order 12866 due to
its lack of significance, this proposed rule is not subject to
Executive Order 13211, entitled Actions Concerning Regulations That
Significantly Affect Energy Supply, Distribution, or Use (66 FR 28355,
May 22, 2001). This proposed rule does not contain any information
collections subject to OMB approval under the Paperwork Reduction Act
(PRA), 44 U.S.C. 3501 et seq., or impose any enforceable duty or
contain any unfunded mandate as described under Title II of the
Unfunded Mandates Reform Act of 1995 (UMRA) (Public Law 104-4). Nor
does it require any special considerations under Executive Order 12898,
entitled Federal Actions to Address Environmental Justice in Minority
Populations and Low-Income Populations (59 FR 7629, February 16, 1994);
or OMB review or any Agency action under Executive Order 13045,
entitled Protection of Children from Environmental Health Risks and
Safety Risks (62 FR 19885, April 23, 1997). This action does not
involve any technical standards that would require Agency consideration
of voluntary consensus standards pursuant to section 12(d) of the
National Technology Transfer and Advancement Act of 1995 (NTTAA),
Public Law 104-113, section 12(d) (15 U.S.C. 272 note). The Regulatory
Flexibility Act (RFA) (5 U.S.C. 601 et seq.) generally requires an
agency to prepare a regulatory flexibility analysis of any rule subject
to notice and comment rulemaking requirements under the Administrative
Procedure Act or any other statute unless the agency certifies that the
rule will not have a significant impact on a substantial number of
small entities. Small entities include small businesses, small
organizations, and small governmental organizations. After considering
the economic impacts of this proposed rule on small entities, I certify
that this action will not have a significant economic impact on a
substantial number of small entities. Establishing an exemption from
the requirement of a pesticide tolerance (or, expanding and
consolidating a tolerance exemption, as is proposed), is in effect, the
removal of a regulatory restriction on pesticide residues in food and
thus such an action will not have any negative economic impact on any
entities, including small entities. In addition, the Agency has
determined that this action will not have a substantial direct effect
on States, on the relationship between the national government and the
States, or on the distribution of power and responsibilities among the
various levels of government, as specified in Executive Order 13132,
entitled Federalism (64 FR 43255, August 10, 1999). Executive Order
13132 requires EPA to develop an accountable process to ensure
``meaningful and timely input by State and local officials in the
development of regulatory policies that have federalism implications.''
``Policies that have federalism implications'' is defined in the
Executive order to include regulations that have ``substantial direct
effects on the States, on the relationship between the national
government and the States, or on the distribution of power and
responsibilities among the various levels of government.'' This
proposed rule directly regulates growers, food processors, food
handlers, and food retailers, not States. This action does not alter
the relationships or distribution of power and responsibilities
established by Congress in the preemption provisions of section
408(n)(4) of FFDCA. For these same reasons, the Agency has determined
that this proposed rule does not have any ``tribal implications'' as
described in Executive Order 13175, entitled Consultation and
Coordination with Indian Tribal Governments (65 FR 67249, November 6,
2000). Executive Order 13175, requires EPA to develop an accountable
process to ensure ``meaningful and timely input by tribal officials in
the development of regulatory policies that have tribal implications.''
``Policies that have tribal implications'' is defined in the Executive
order to include regulations that have ``substantial direct effects on
one or more Indian tribes, on the relationship between the Federal
Government and the Indian tribes, or on the distribution of power and
responsibilities between the Federal Government and Indian tribes.''
This proposed rule will not have substantial direct effects on tribal
governments, on the relationship between the Federal Government and
Indian tribes, or on the distribution of power and responsibilities
between the Federal Government and Indian tribes, as specified in
Executive Order 13175. Thus, Executive Order 13175 does not apply to
this proposed rule.
List of Subjects in 40 CFR Part 180
Environmental protection, Administrative practice and procedure,
Agricultural commodities, Pesticides and pests, Reporting and
recordkeeping requirements.
Dated: February 5, 2005.
Lois Rossi,
Director, Registration Division, Office of Pesticide Programs.
Therefore, it is proposed that 40 CFR chapter I be amended as
follows:
PART 180--[AMENDED]
1. The authority citation for part 180 would continue to read as
follows:
Authority: 21 U.S.C. 321(q), 346(a) and 371.
Sec. 180.910 [Amended]
2. Section 180.910 is proposed to be amended by removing the
following entries from the table: Ethoxylated lignosulfonic acid,
sodium salt; lignosulfonate, ammonium, calcium, magnesium, potassium,
sodium, and zinc salts; oxidized pine lignin, sodium salt; and pine
lignin.
3. Section 180.910 is proposed to be amended by adding
alphabetically the following entries to the table to read as follows:
Sec. 180.910 Inert ingredients used pre- and post-harvest; exemptions
from the requirement of a tolerance.
* * * * *
------------------------------------------------------------------------
Inert ingredients Limits Uses
------------------------------------------------------------------------
* * * * * * *
Lignin (CAS No.9005-53-2)...... ................. surfactant, related
adjuvants of
surfactants
Lignin, alkali (CAS No. 8068-05- ................. Surfactant, related
1). adjuvants of
surfactants
Lignin, alkali, oxidized, ................. Surfactant, related
sodium salt (CAS No. 68201-23- adjuvants of
0). surfactants
Lignin alkali, reaction ................. Surfactant, related
products with disodium sulfite adjuvants of
and formaldehyde (CAS No. surfactants
105859-97-0).
Lignin alkali, reaction ................. Surfactant, related
products with formaldehyde and adjuvants of
sodium bisulfite (CAS No. surfactants
68512-35-6).
Lignosulfonic acid (CAS . No. ................. Surfactant, related
8062-15-5). adjuvants of
surfactants
Lignosulfonic acid, ammonium ................. Surfactant, related
calcium salt (CAS No. 12710-04- adjuvants of
2). surfactants
[[Page 7920]]
Lignosulfonic acid, ammonium ................. Surfactant, related
magnesium salt (CAS No. 123175- adjuvants of
37-1). surfactants
Lignosulfonic acid, ammonium ................. Surfactant, related
salt (CAS No. 8061-53-8). adjuvants of
surfactants
Lignosulfonic acid, ammonium ................. Surfactant, related
sodium salt (CAS No. 166798-73- adjuvants of
8). surfactants
Lignosulfonic acid, calcium ................. Surfactant, related
magnesium salt (CAS No. 55598- adjuvants of
86-2). surfactants
Lignosulfonic acid, calcium ................. Surfactant, related
salt (CAS No. 8061-52-7). adjuvants of
surfactants
Lignosulfonic acid, calcium ................. Surfactant, related
sodium salt (CAS No. 37325-33- adjuvants of
0). surfactants
Lignosulfonic acid, ................. Surfactant, related
ethoxylated, sodium salt (CAS adjuvants of
No. 68611-14-3). surfactants
Lignosulfonic acid, magnesium ................. Surfactant, related
salt (CAS No. 8061-54-9). adjuvants of
surfactants
Lignosulfonic acid, potassium ................. Surfactant, related
salt (CAS No. 37314-65-1). adjuvants of
surfactants
Lignosulfonic acid, sodium salt ................. Surfactant, related
(CAS No. 8061-51-6). adjuvants of
surfactants
Lignosulfonic acid, sodium ................. Surfactant, related
salt, oxidized (CAS No. 68855- adjuvants of
41-4). surfactants
Lignosulfonic acid, sodium ................. Surfactant, related
salt, polymer with HCHO and adjuvants of
phenol (CAS No. 37207-89-9). surfactants
Lignosulfonic acid, sodium ................. Surfactant, related
salt, sulfomethylated (CAS No. adjuvants of
68512-34-5). surfactants
Lignosulfonic acid, zinc salt ................. Surfactant, related
(CAS No. 57866-49-6). adjuvants of
surfactants
* * * * * * *
Sulfite liquors and cooking ................. Surfactant, related
liquid, spent, oxidized (CAS adjuvants of
No. 68514-09-0). surfactants
* * * * * * *
------------------------------------------------------------------------
* * * * *
Sec. 180.930 [Amended]
4. Section 180.930 is proposed to be amended by removing the
following entries from the table: Lignosulfonate, ammonium, calcium,
magnesium, potassium, sodium, and zinc salts; oxidized pine lignin,
sodium salt; and pine lignin.
5. Section 180.930 is proposed to be amended by adding
alphabetically the following entries to the table to read as follows:
Sec. 180.930 Inert ingredients applied to animals; exemptions from
the requirement of a tolerance.
* * * * *
------------------------------------------------------------------------
Inert ingredients Limits Uses
------------------------------------------------------------------------
* * * * * * *
Lignin (CAS No. 9005-53-2)..... ................. Surfactant, related
adjuvants of
surfactants
Lignin, alkali (CAS No. 8068-05- ................. Surfactant, related
1). adjuvants of
surfactants
Lignin, alkali, oxidized, ................. Surfactant, related
sodium salt (CAS No. 68201-23- adjuvants of
0). surfactants
Lignin alkali, reaction ................. Surfactant, related
products with disodium sulfite adjuvants of
and formaldehyde (CAS No. surfactants
105859-97-0).
Lignin alkali, reaction ................. Surfactant, related
products with formaldehyde and adjuvants of
sodium bisulfite (CAS No. surfactants
68512-35-6).
Lignosulfonic acid (CAS No. ................. Surfactant, related
8062-15-5). adjuvants of
surfactants
Lignosulfonic acid, ammonium ................. Surfactant, related
calcium salt (CAS No. 12710-04- adjuvants of
2). surfactants
Lignosulfonic acid, ammonium ................. Surfactant, related
magnesium salt (CAS No. 123175- adjuvants of
37-1). surfactants
Lignosulfonic acid, ammonium ................. Surfactant, related
salt (CAS No. 8061-53-8). adjuvants of
surfactants
Lignosulfonic acid, ammonium ................. Surfactant, related
sodium salt (CAS No. 166798-73- adjuvants of
8). surfactants
Lignosulfonic acid, calcium ................. Surfactant, related
magnesium salt (CAS No. 55598- adjuvants of
86-2). surfactants
Lignosulfonic acid, calcium ................. Surfactant, related
salt (CAS No. 8061-52-7). adjuvants of
surfactants
Lignosulfonic acid, calcium ................. Surfactant, related
sodium salt (CAS No. 37325-33- adjuvants of
0). surfactants
Lignosulfonic acid, ................. Surfactant, related
ethoxylated, sodium salt (CAS adjuvants of
No. 68611-14-3). surfactants
Lignosulfonic acid, magnesium ................. Surfactant, related
salt (CAS No. 8061-54-9). adjuvants of
surfactants
Lignosulfonic acid, potassium ................. Surfactant, related
salt (CAS No. 37314-65-1). adjuvants of
surfactants
Lignosulfonic acid, sodium salt ................. Surfactant, related
(CAS No. 8061-51-6). adjuvants of
surfactants
Lignosulfonic acid, sodium ................. Surfactant, related
salt, oxidized (CAS No. 68855- adjuvants of
41-4). surfactants
Lignosulfonic acid, sodium ................. Surfactant, related
salt, polymer with HCHO and adjuvants of
phenol (CAS No. 37207-89-9). surfactants
Lignosulfonic acid, sodium ................. Surfactant, related
salt, sulfomethylated (CAS No. adjuvants of
68512-34-5). surfactants
Lignosulfonic acid, zinc salt ................. Surfactant, related
(CAS No. 57866-49-6). adjuvants of
surfactants
[[Page 7921]]
* * * * * * *
Sulfite liquors and cooking ................. Surfactant, related
liquid, spent, oxidized (CAS adjuvants of
No. 68514-09-0). surfactants
* * * * * * *
------------------------------------------------------------------------
* * * * *
[FR Doc. 05-2986 Filed 2-15-05; 8:45 am]
BILLING CODE 6560-50-S
