

[Federal Register: May 3, 2006 (Volume 71, Number 85)]
[Rules and Regulations]               
[Page 25942-25945]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr03my06-11]                         

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2005-0301; FRL-8060-3]

 
Glufosinate Ammonium; Pesticide Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes tolerances for indirect or 
inadvertent residues of glufosinate ammonium and its metabolite in or 
on raw agricultural commodities. Bayer CropScience requested this 
tolerance under the Federal Food, Drug, and Cosmetic Act (FFDCA), as 
amended by the Food Quality Protection Act of 1996 (FQPA).

DATES: This regulation is effective May 3, 2006. Objections and 
requests for hearings must be received on or before July 3, 2006.

ADDRESSES:  To submit a written objection or hearing request follow the 
detailed instructions as provided in Unit VI. of the SUPPLEMENTARY 
INFORMATION. EPA has established a docket for this action under Docket 
identification (ID) number EPA-HQ-OPP-2005-0301. All documents in the 
docket are listed on the http://www.regulations.gov Web site. (EDOCKET, EPA's 

electronic public docket and comment system was replaced on November 
25, 2005, by an enhanced Federal-wide electronic docket management and 
comment system located at http://www.regulations.gov. Follow the on-

line instructions.) 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.
     Important Note: OPP will be moving to a new location the 
first week of May 2006. As a result, from Friday, April 28 to Friday, 
May 5, 2006, the OPP Regulatory Public Docket will NOT be accepting any 
deliveries at the Crystal Mall 2 address and this facility 
will be closed to the public. Beginning on May 8, 2006, the OPP 
Regulatory Public Docket will reopen at 8:30 a.m. and deliveries will 
be accepted in Rm. S-4400, One Potomac Yard (South Building), 2777 S. 
Crystal Drive, Arlington, VA 22202. The mail code for the mailing 
address will change to (7502P), but will otherwise remain the same. The 
OPP Regulatory Public Docket telephone number and hours of operation 
will remain the same after the move.

FOR FURTHER INFORMATION CONTACT:  Joanne I. Miller, Registration 
Division (7505C), Office of Pesticide Programs, Environmental 
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-
0001; telephone number: (703) 305-6224; e-mail address: 
miller.joanne@epamail.epa.gov.


SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

    You may be potentially affected by this action if you are an 
agricultural producer, food manufacturer, or pesticide manufacturer. 
Potentially affected entities may include, but are not limited to:
     Crop production (NAICS 111), e.g., agricultural workers; 
greenhouse, nursery, and floriculture workers; farmers.
     Animal production (NAICS 112), e.g., cattle ranchers and 
farmers, dairy cattle farmers, livestock farmers.

[[Page 25943]]

     Food manufacturing (NAICS 311), e.g., agricultural 
workers; farmers; greenhouse, nursery, and floriculture workers; 
ranchers; pesticide applicators.
     Pesticide manufacturing (NAICS 32532), e.g., agricultural 
workers; commercial applicators; farmers; greenhouse, nursery, and 
floriculture workers; residential users.
    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 underFOR 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 December 21, 2005 (70 FR 75808) (FRL-
7751-5), EPA issued a notice pursuant to section 408(d)(3) of FFDCA, 21 
U.S.C. 346a(d)(3), announcing the filing of a pesticide petition (PP 
5F6954) by Bayer CropScience, 2 T.W. Alexander Drive, Research Triangle 
Park, NC 27709. The petition requested that 40 CFR 180.473(d) be 
amended by establishing tolerances for indirect or inadvertent residues 
of the herbicide glufosinate ammonium, butanoic acid, 2-amino-4-
(hydroxymethylphosphinyl)-, monoammonium salt and its metabolite, 3-
methylphosphinicopropionic acid expressed as 2-amino-4-
(hydroxymethylphosphinyl) butanoic acid equivalents in or on forage, 
hay, and straw of small grains (Crop Group 16) at 0.2 parts per million 
(ppm). That notice included a summary of the petition prepared by Bayer 
CropScience, the registrant. Based on available data the tolerances are 
being established at 0.40 ppm for glufosinate ammonium and its 
metabolite for specific small grain crops. One comment was received on 
the notices of filing. EPA's response to this comment is discussed in 
Unit IV.C.
    Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish tolerances 
(the legal limit for a pesticide chemical residue in or on a food) only 
if EPA determines that the tolerance is ``safe.'' Section 
408(b)(2)(A)(ii) of FFDCA defines ``safe'' to mean that ``there is a 
reasonable certainty that no harm will result from aggregate exposure 
to the pesticide chemical residue, including all anticipated dietary 
exposures and all other exposures for which there is reliable 
information.'' This includes exposure through drinking water and in 
residential settings, but does not include occupational exposure. 
Section 408(b)(2)(C) of FFDCA requires EPA to give special 
consideration to exposure of infants and children to the pesticide 
chemical residue in establishing tolerances and to ``ensure that there 
is a reasonable certainty that no harm will result to infants and 
children from aggregate exposure to the pesticide chemical residue. . . 
.''
    EPA performs a number of analyses to determine the risks from 
aggregate exposure to pesticide residues. For further discussion of the 
regulatory requirements of section 408 of FFDCA and a complete 
description of the risk assessment process, see http://www.epa.gov/fedrgstr/
 EPA-PEST/ 1997/ November/ Day-26/ p30948.htm.


III. Aggregate Risk Assessment and Determination of Safety

    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. EPA has sufficient data to assess the hazards of and to 
make a determination on aggregate exposure, consistent with section 
408(b)(2) of FFDCA, for tolerances for indirect or inadvertent residues 
of the herbicide glufosinate ammonium, butanoic acid, 2-amino-4-
(hydroxymethylphosphinyl)-, monoammonium salt and its metabolite, 3-
methylphosphinicopropionic acid in or on barley hay, barley straw, 
buckwheat fodder, buckwheat forage, oat forage, oat hay, oat straw, rye 
forage, rye straw, teosinte, triticale, wheat forage, wheat hay and 
wheat straw at 0.40 ppm. EPA's assessment of exposures and risks 
associated with establishing the tolerance follows.

A. Toxicological Profile

    EPA has evaluated the available toxicity data and considered its 
validity, completeness, and reliability as well as the relationship of 
the results of the studies 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. Specific information on the studies received and the nature 
of the toxic effects caused by glufosinate ammonium as well as the no 
observed adverse effect level (NOAEL) and the lowest observed adverse 
effect level (LOAEL) from the toxicity studies are discussed in the 
Federal Register of September 29, 2003 (68 FR 55833) (FRL-7327-9).

B. Toxicological Endpoints

    A summary of the toxicological endpoints for glufosinate ammonium 
used for human risk assessment is discussed in Unit III.B. of the final 
rule published in the Federal Register of September 29, 2003.

C. Exposure Assessment

    The proposed inadvertent tolerances will result in the 
establishment of tolerances in or on feed commodities only. These 
tolerances do not impact the livestock residue assumptions made in the 
previous dietary exposure analysis. EPA concludes that establishment of 
tolerances for indirect or inadvertent residues of glufosinate ammonium 
does not alter the residue assumptions discussed in the final rule 
published in the Federal Register of September 29, 2003. The Exposure 
Assessment remains identical.

D. Safety Factor for Infants and Children

    A summary of the safety factor for infants and children for 
glufosinate ammonium is discussed in Unit III.D. of the final rule 
published in the Federal Register of September 29, 2003.

E. Aggregate Risks and Determination of Safety

    Establishing these new tolerances will not increase exposure to 
glufosinate ammonium above the exposure levels previously assessed. EPA 
is relying on the aggregate risk assessment and determination of the 
safety for glufosinate ammonium in Unit III.E. of the final rule 
published in the Federal Register of September 29, 2003.
    The risk assessment employed a 1,000x uncertainty factor for 
dietary and residential dermal assessment (10x database uncertainty 
factor; 1x FQPA factor) and 3,000x uncertainty factor for inhalation. 
EPA has received a developmental neurotoxicity (DNT) study but has not 
received a comparative glutamate synthetase study in young and adult 
animals. The DNT study does not effect the endpoints chosen and the 
previous risk assessment

[[Page 25944]]

and EPA concludes that the endpoints and uncertainty factors used in 
the previous remain appropriate.
    EPA concludes that there is a reasonable certainty that no harm 
will result to the general population, and to infants and children from 
aggregate exposure to glufosinate ammonium residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    Adequate enforcement methodology (gas chromatography) is available 
to enforce the tolerance expression. The method may be requested from: 
Chief, Analytical Chemistry Branch, Environmental Science Center, 701 
Mapes Rd., Ft. Meade, MD 20755-5350; telephone number: (410) 305-2905; 
e-mail address: residuemethods@epa.gov.

B. International Residue Limits

    There are no Codex, Canadian or Mexican maximum residue limits 
established for residues of glufosinate ammonium in or on small grain 
crops.

C. Response to Comments

    Public comments were received from B. Sachau who objected to the 
proposed tolerances because of the amounts of pesticides already 
consumed and carried by the American population. She further indicated 
that testing conducted on animals have absolutely no validity and are 
cruel to the test animals. B. Sachau's comments contained no scientific 
data or evidence to rebut the Agency's conclusion that there is a 
reasonable certainty that no harm will result from aggregate exposure 
to glufosinate ammonium, including all anticipated dietary exposures 
and all other exposures for which there is reliable information. EPA 
has responded to B. Sachau's generalized comments on numerous previous 
occasions. (70 FR 1349, January 7, 2005); (69 FR 63083, October 29, 
2004).

V. Conclusion

    Therefore, tolerances are established for indirect or inadvertent 
residues of the herbicide glufosinate ammonium, butanoic acid, 2-amino-
4-(hydroxymethylphosphinyl)-, monoammonium salt and its metabolite, 3-
methylphosphinicopropionic acid in or on barley hay, barley straw, 
buckwheat fodder, buckwheat forage, oat forage, oat hay, oat straw, rye 
forage, rye straw, teosinte, triticale, wheat forage, wheat hay and 
wheat straw at 0.40 ppm.

VI. 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 
tolerances issued by EPA under new section 408(d) of FFDCA, as was 
provided in the old 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 EPA-HQ-OPP-2005-0301 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 July 3, 
2006.
    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 issue(s) 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 VI.A.1., 
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 EPA-HQ-OPP-2005-0301, to: 
Public Information and Records Integrity Branch, Information Technology 
and Resources Management 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.

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 issue(s) in the manner sought 
by the requestor would be adequate to justify the action requested (40 
CFR 178.32).

VII. Statutory and Executive Order Reviews

    This final rule establishes tolerances 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

[[Page 25945]]

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). Since tolerances and 
exemptions that are established on the basis of a petition under 
section 408(d) of FFDCA, such as the tolerance in this final rule, do 
not require the issuance of a proposed rule, the requirements of the 
Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et seq.) do not apply. 
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 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 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.

VIII. 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: April 24, 2006.
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), 346a and 371.


0
2. Section 180.473 is amended by adding text to paragraph (d) after the 
paragraph heading to read as follows:


Sec.  180.473  Glufosinate ammonium; tolerances for residues.

* * * * *
    (d) * * * Tolerances are established for indirect or inadvertent 
residues of the herbicide glufosinate ammonium, butanoic acid, 2-amino-
4-(hydroxymethylphosphinyl)-, monoammonium salt and its metabolite, 3-
methylphosphinicopropionic acid in or on the following raw agricultural 
commodities when present therein as a result of the application of 
glufosinate ammonium to crops listed in paragraph (a) of this section:

------------------------------------------------------------------------
                                                              Parts per
                         Commodity                             million
------------------------------------------------------------------------
Barley, hay................................................         0.40
Barley, straw..............................................         0.40
Buckwheat, fodder..........................................         0.40
Buckwheat, forage..........................................         0.40
Oat, forage................................................         0.40
Oat, hay...................................................         0.40
Oat, straw.................................................         0.40
Rye, forage................................................         0.40
Rye, straw.................................................         0.40
Teosinte...................................................         0.40
Triticale..................................................         0.40
Wheat, forage..............................................         0.40
Wheat, hay.................................................         0.40
Wheat, straw...............................................         0.40
------------------------------------------------------------------------


[FR Doc. 06-4162 Filed 5-2-06; 8:45 am]

BILLING CODE 6560-50-S
