[Federal Register Volume 70, Number 31 (Wednesday, February 16, 2005)]
[Proposed Rules]
[Pages 7912-7921]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 05-2986]
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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.
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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: http://www.regulations.gov/.
Follow the on-line instructions for submitting comments.
Agency Website: http://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 [email protected], 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
http://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 http://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:
[email protected].
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 (http://www.epa.gov/edocket/), you may
access this Federal Register document electronically through the EPA
Internet under the ``Federal Register'' listings at http://www.epa.gov/fedrgstr/. A frequently updated electronic version of 40 CFR part 180
is available on E-CFR Beta Site Two at http://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
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Chemical Chemical formula CAS No.
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Lignosulfonic acid C213H246O88S64 8062-15-5
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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 (http://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)
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Species Study type Results
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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
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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
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Chemical description Study
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Pine lignin, sodium salt Acute oral rat; LD50 is
greater than 2 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
[[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)
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Water solubility (g/
Chemical Physical state Boiling point Liter (L)) Vapor pressure Molecular weight
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Lignosulfonic acid, sodium salt Solid >500 >500 <0.000001 10,000
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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 http://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 http://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