[Federal Register Volume 70, Number 143 (Wednesday, July 27, 2005)]
[Rules and Regulations]
[Pages 43309-43313]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 05-14887]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[OPP-2005-0171; FRL-7720-3]


Lignosulfonates; Exemptions from the Requirement of a Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: The Agency is establishing 44 exemptions from the requirement 
of a tolerance for residues of various lignosulfonate chemicals in or 
on raw agricultural commodities when used as inert ingredients in 
pesticide formulations applied to growing crops or to raw agricultural 
commodities after harvest, or to animals under the Federal Food, Drug, 
and Cosmetic Act (FFDCA), as amended by the Food Quality Protection Act 
of 1996 (FQPA). This regulation eliminates the need to establish a 
maximum permissible level for residues of these lignosulfonate 
chemicals.

DATES: This regulation is effective July 27, 2005. Objections and 
requests for hearings must be received on or before September 26, 2005.

ADDRESSES: To submit a written objection or hearing request follow the 
detailed instructions as provided in Unit III. of the SUPPLEMENTARY 
INFORMATION. EPA has established a docket for this action under docket 
identification (ID) number OPP-2005-0171. 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., Confidential Business Information (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.,

[[Page 43310]]

 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: Kathryn Boyle, Registration Division 
(7505C), Office of Pesticide Programs, Environmental Protection Agency, 
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone 
number: (703) 305-6304; fax number: (703) 305-0599; 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/.

II. Background and Statutory Findings

    In the Federal Register of February 16, 2005 (70 FR 7912) (FRL-
7691-9), EPA issued a proposed rule under section 408(e) of FFDCA, 21 
U.S.C. 346a, as amended by FQPA (Public Law 104-170). The Agency 
proposed to establish 44 tolerance exemptions for residues of various 
lignosulfonate chemicals in or on raw agricultural commodities when 
used as inert ingredients in pesticide formulations applied to growing 
crops or to raw agricultural commodities after harvest, or to animals. 
The 22 specific chemicals are identified in the regulatory text.
    One comment was received from a private citizen. The comment 
consisted of the following statement ``I oppose and object to any use 
or sale of this product. I certainly find its use as a feed for animals 
to be highly dangerous to Americans.'' Attached to the comment was a 
news article critical of EPA's regulation of rat poisons. The Agency 
understands the commentor's concerns and recognizes that some 
individuals believe that pesticides should be banned completely. 
However, under the existing legal framework provided by section 409 of 
FFDCA, EPA is authorized to establish pesticide tolerances or 
exemptions after demonstrating that the pesticide meets the safety 
standard imposed by the statute. The commentor has not provided the 
Agency with specific rationale or additional information pertaining to 
the legal standards in section 409 of FFDCA for opposing the 
establishment of a tolerance exemption for these lignosulfonate 
chemicals. In the absence of any additional information of a factual 
nature, the Agency can not effectively respond to the commentor's 
disagreement with the Agency's decision. Additionally, EPA would note 
that this action applies to inert ingredients in pesticide formulations 
applied to growing crops or to raw agricultural commodities after 
harvest, or to animals, and not rat poisons.
    No other comments were received.
    Accordingly, based on the reasons set forth in the preamble to the 
proposed rule, EPA is establishing 44 new tolerance exemptions for 
lignosulfonate chemicals.

III. Objections and Hearing Requests

    Under section 408(g) of FFDCA, as amended by FQPA, any person may 
file an objection to any aspect of this regulation and may also request 
a hearing on those objections. The EPA procedural regulations which 
govern the submission of objections and requests for hearings appear in 
40 CFR part 178. Although the procedures in those regulations require 
some modification to reflect the amendments made to FFDCA by FQPA, EPA 
will continue to use those procedures, with appropriate adjustments, 
until the necessary modifications can be made. The new section 408(g) 
of FFDCA provides essentially the same process for persons to 
``object'' to a regulation for an exemption from the requirement of a 
tolerance issued by EPA under new section 408(d) of FFDCA, as was 
provided in the old FFDCA sections 408 and 409 of FFDCA. However, the 
period for filing objections is now 60 days, rather than 30 days.

A. What Do I Need to Do to File an Objection or Request a Hearing?

    You must file your objection or request a hearing on this 
regulation in accordance with the instructions provided in this unit 
and in 40 CFR part 178. To ensure proper receipt by EPA, you must 
identify docket ID number OPP-2005-0171 in the subject line on the 
first page of your submission. All requests must be in writing, and 
must be mailed or delivered to the Hearing Clerk on or before September 
26, 2005.
    1. Filing the request. Your objection must specify the specific 
provisions in the regulation that you object to, and the grounds for 
the objections (40 CFR 178.25). If a hearing is requested, the 
objections must include a statement of the factual issues on which a 
hearing is requested, the requestor's contentions on such issues, and a 
summary of any evidence relied upon by the objector (40 CFR 178.27). 
Information submitted in connection with an objection or hearing 
request may be claimed confidential by marking any part or all of that 
information as CBI. Information so marked will not be disclosed except 
in accordance with procedures set forth in 40 CFR part 2. A copy of the 
information that does not contain CBI must be submitted for inclusion 
in the public record. Information not marked confidential may be 
disclosed publicly by EPA without prior notice.
    Mail your written request to: Office of the Hearing Clerk (1900L), 
Environmental Protection Agency, 1200 Pennsylvania Ave., NW., 
Washington, DC 20460-0001. You may also deliver your request to the 
Office of the Hearing Clerk in Suite 350, 1099 14\th\ St., NW., 
Washington, DC 20005. The Office of the Hearing Clerk is open from 8 
a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The 
telephone number for the Office of the Hearing Clerk is (202) 564-6255.
    2. Copies for the Docket. In addition to filing an objection or 
hearing request with the Hearing Clerk as described in Unit III.A., you 
should also send a copy of your request to the PIRIB for its inclusion 
in the official record that is described in ADDRESSES. Mail your 
copies, identified by docket ID number OPP-2005-0171, to: Public 
Information and Records Integrity Branch,

[[Page 43311]]

Information Resources and Services Division (7502C), Office of 
Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania 
Ave., NW., Washington, DC 20460-0001. In person or by courier, bring a 
copy to the location of the PIRIB described in ADDRESSES. You may also 
send an electronic copy of your request via e-mail to: [email protected]. Please use an ASCII file format and avoid the use of 
special characters and any form of encryption. Copies of electronic 
objections and hearing requests will also be accepted on disks in 
WordPerfect 6.1/8.0 or ASCII file format. Do not include any CBI in 
your electronic copy. You may also submit an electronic copy of your 
request at many Federal Depository Libraries.

B. When Will the Agency Grant a Request for a Hearing?

    A request for a hearing will be granted if the Administrator 
determines that the material submitted shows the following: There is a 
genuine and substantial issue of fact; there is a reasonable 
possibility that available evidence identified by the requestor would, 
if established resolve one or more of such issues in favor of the 
requestor, taking into account uncontested claims or facts to the 
contrary; and resolution of the factual issues in the manner sought by 
the requestor would be adequate to justify the action requested (40 CFR 
178.32).

IV. Statutory and Executive Order Reviews

    This final rule establishes an exemption from the tolerance 
requirement under section 408(d) of FFDCA in response to a petition 
submitted to the Agency. 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 rule has been exempted from review under Executive 
Order 12866 due to its lack of significance, this rule is not subject 
to Executive Order 13211, Actions Concerning Regulations That 
Significantly Affect Energy Supply, Distribution, or Use (66 FR 28355, 
May 22, 2001). This final 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 Agency 
hereby certifies that this rule will not have significant negative 
economic impact on a substantial number of 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, entitledFederalism (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 final 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 the FFDCA. For these same reasons, the Agency 
has determined that this 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 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 rule.

V. Congressional Review Act

    The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the 
Small Business Regulatory Enforcement Fairness Act of 1996, generally 
provides that before a rule may take effect, the agency promulgating 
the rule must submit a rule report, which includes a copy of the rule, 
to each House of the Congress and to the Comptroller General of the 
United States. EPA will submit a report containing this rule and other 
required information to the U.S. Senate, the U.S. House of 
Representatives, and the Comptroller General of the United States prior 
to publication of this final rule in the Federal Register. This final 
rule is not a ``major rule'' as defined by 5 U.S.C. 804(2).

List of Subjects in 40 CFR Part 180

    Environmental protection, Administrative practice and procedure, 
Agricultural commodities, Pesticides and pests, Reporting and 
recordkeeping requirements.


    Dated: July 18, 2005.
Lois Rossi,
Director, Registration Division, Office of Pesticide Programs.

0
Therefore, 40 CFR chapter I is amended as follows:

PART 180--[AMENDED]

0
1. The authority citation for part 180 continues to read as follows:

    Authority: 21 U.S.C. 321(q), 346(a) and 371.


Sec.  180.910  [Amended]

0
2. Section 180.910 is 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.

0
3. Section 180.910 is amended by adding alphabetically the following 
entries to the table to read as follows:

[[Page 43312]]

Sec.  180.910  Inert ingredients used pre- and post-harvest; exemptions 
from the requirement of a tolerance.

* * * * *

------------------------------------------------------------------------
        Inert ingredients               Limits               Uses
------------------------------------------------------------------------
                              * * * * * * *
 Lignin (CAS Reg. No. 9005-53-2)  ..................  Surfactant,
                                                       related adjuvants
                                                       of surfactants
Lignin, alkali (CAS Reg. No.      ..................  Do.
 8068-05-1).
Lignin, alkali, oxidized, sodium  ..................  Do.
 salt (CAS Reg. No. 68201-23-0).
Lignin alkali reaction products   ..................  Do.
 with disodium sulfite and
 formaldehyde (CAS Reg. No.
 105859-97-0).
Lignin alkali reaction products   ..................  Do.
 with formaldehyde and sodium
 bisulfite (CAS Reg. No. 68512-
 35-6).
Lignosulfonic acid (CAS Reg. No.  ..................  Do.
 8062-15-5).
Lignosulfonic acid, ammonium      ..................  Do.
 calcium salt (CAS Reg. No.
 12710-04-2).
Lignosulfonic acid, ammonium      ..................  Do.
 magnesium salt (CAS Reg. No.
 123175-37-1).
Lignosulfonic acid, ammonium      ..................  Do.
 salt (CAS Reg. No. 8061-53-8).
Lignosulfonic acid, ammonium      ..................  Do.
 sodium salt (CAS Reg. No.
 166798-73-8).
Lignosulfonic acid, calcium       ..................  Do.
 magnesium salt (CAS Reg. No.
 55598-86-2).
Lignosulfonic acid, calcium salt  ..................  Do.
 (CAS Reg. No. 8061-52-7).
Lignosulfonic acid, calcium       ..................  Do.
 sodium salt (CAS Reg. No. 37325-
 33-0).
Lignosulfonic acid, ethoxylated,  ..................  Do.
 sodium salt (CAS Reg. No. 68611-
 14-3).
Lignosulfonic acid, magnesium     ..................  Do.
 salt (CAS Reg. No. 8061-54-9).
Lignosulfonic acid, potassium     ..................  Do.
 salt (CAS Reg. No. 37314-65-1).
Lignosulfonic acid, sodium salt   ..................  Do.
 (CAS Reg. No. 8061-51-6).
Lignosulfonic acid, sodium salt,  ..................  Do.
 oxidized (CAS Reg. No. 68855-41-
 4).
Lignosulfonic acid, sodium salt,  ..................  Do.
 polymer with formaldehyde and
 phenol (CAS Reg. No. 37207-89-
 9).
Lignosulfonic acid, sodium salt,  ..................  Do.
 sulfomethylated (CAS Reg. No.
 68512-34-5).
Lignosulfonic acid, zinc salt     ..................  Do.
 (CAS Reg. No. 57866-49-6).
                              * * * * * * *
 Sulfite liquors and cooking      ..................  Surfactant,
 liquors, spent, oxidized (CAS                         related adjuvants
 Reg. No. 68514-09-0).                                 of surfactants
                              * * * * * * *
------------------------------------------------------------------------

* * * * *


Sec.  180.930  [Amended]

0
4. Section 180.930 is 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.

0
5. Section 180.930 is 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 Reg. No. 9005-53-2)  ..................  Surfactant,
                                                       related adjuvants
                                                       of surfactants
Lignin, alkali (CAS Reg. No.      ..................  Do.
 8068-05-1).
Lignin, alkali, oxidized, sodium  ..................  Do.
 salt (CAS Reg. No. 68201-23-0).
Lignin alkali reaction products   ..................  Do.
 with disodium sulfite and
 formaldehyde (CAS Reg. No.
 105859-97-0).
Lignin alkali reaction products   ..................  Do.
 with formaldehyde and sodium
 bisulfite (CAS Reg. No. 68512-
 35-6).
Lignosulfonic acid (CAS Reg. No.  ..................  Do.
 8062-15-5).
Lignosulfonic acid, ammonium      ..................  Do.
 calcium salt (CAS Reg. No.
 12710-04-2).
Lignosulfonic acid, ammonium      ..................  Do.
 magnesium salt (CAS Reg. No.
 123175-37-1).

[[Page 43313]]

 
Lignosulfonic acid, ammonium      ..................  Do.
 salt (CAS Reg. No. 8061-53-8).
Lignosulfonic acid, ammonium      ..................  Do.
 sodium salt (CAS Reg. No.
 166798-73-8).
Lignosulfonic acid, calcium       ..................  Do.
 magnesium salt (CAS Reg. No.
 55598-86-2).
Lignosulfonic acid, calcium salt  ..................  Do.
 (CAS Reg. No. 8061-52-7).
Lignosulfonic acid, calcium       ..................  Do.
 sodium salt (CAS Reg. No. 37325-
 33-0).
Lignosulfonic acid, ethoxylated,  ..................  Do.
 sodium salt (CAS Reg. No. 68611-
 14-3).
Lignosulfonic acid, magnesium     ..................  Do.
 salt (CAS Reg. No. 8061-54-9).
Lignosulfonic acid, potassium     ..................  Do.
 salt (CAS Reg. No. 37314-65-1).
Lignosulfonic acid, sodium salt   ..................  Do.
 (CAS Reg. No. 8061-51-6).
Lignosulfonic acid, sodium salt,  ..................  Do.
 oxidized (CAS Reg. No. 68855-41-
 4).
Lignosulfonic acid, sodium salt,  ..................  Do.
 polymer with formaldehyde and
 phenol (CAS Reg. No. 37207-89-
 9).
Lignosulfonic acid, sodium salt,  ..................  Do.
 sulfomethylated (CAS Reg. No.
 68512-34-5).
Lignosulfonic acid, zinc salt     ..................  Do.
 (CAS Reg. No. 57866-49-6).
                              * * * * * * *
 Sulfite liquors and cooking      ..................  Surfactant,
 liquors, spent, oxidized (CAS                         related adjuvants
 Reg. No. 68514-09-0).                                 of surfactants
                              * * * * * * *
------------------------------------------------------------------------

* * * * *

[FR Doc. 05-14887 Filed 7-26-05; 8:45 am]
BILLING CODE 6560-50-S