[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 oral 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.
------------------------------------------------------------------------
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)
------------------------------------------------------------------------
            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 
Ageals 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 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