[Federal Register: January 28, 2004 (Volume 69, Number 18)]
[Rules and Regulations]
[Page 4073-4077]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr28ja04-9]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[OPP-2003-0341; FRL-7338-4]
Lactic Acid, n-Butyl Ester, (S) and Lactic Acid, Ethyl Ester,
(S); Exemption from the Requirement of a Tolerance
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
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SUMMARY: This regulation establishes an exemption from the requirement
of a tolerance for residues of lactic acid, n-butyl ester, (S) and
lactic acid, ethyl ester, (S) when used as an inert ingredient in
pesticide products. PURAC America Inc. submitted a petition to EPA
under the Federal Food, Drug, and Cosmetic Act (FFDCA), as amended by
the Food Quality Protection Act of 1996 (FQPA), requesting an exemption
from the requirement of a tolerance.
DATES: This regulation is effective January 28, 2004. Objections and
requests for hearings, identified by docket ID number OPP-2003-0341,
must be received on or before March 29, 2004.
ADDRESSES: Written objections and hearing requests may be submitted
electronically, by mail, or through hand delivery/courier. Follow the
detailed instructions as provided in Unit VIII. of the SUPPLEMENTARY
INFORMATION.
FOR FURTHER INFORMATION CONTACT: Princess Campbell, Registration
Division (7505C), Office of Pesticide Programs, Environmental
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-
0001; telephone number: (703) 308-8033; e-mail address:
campbell.princess@epa.gov.
SUPPLEMENTARY INFORMATION:
I. General Information
A. Does this Action Apply to Me?
You may be potentially affected by this action if you are an
agricultural producer, food manufacturer, or pesticide manufacturer.
Potentially affected entities may include, but are not limited to:
Crop production (NAICS code 111)
Animal production (NAICS code 112)
Food manufacturing (NAICS code 311)
Pesticide manufacturing (NAICS code 32532)
This listing is not intended to be exhaustive, but rather provides
a guide for readers regarding entities likely to be affected by this
action. Other types of entities not listed in this unit could also be
affected. The North American Industrial Classification System (NAICS)
codes have been provided to assist you and others in determining
whether this action might apply to certain entities. If you have any
questions regarding the applicability of this action to a particular
entity, consult the person listed under FOR FURTHER INFORMATION
CONTACT.
[[Page 4074]]
B. How Can I Get Copies of this Document and Other Related Information?
1. Docket. EPA has established an official public docket for this
action under docket identification (ID) number OPP-2003-0341. The
official public docket consists of the documents specifically
referenced in this action, any public comments received, and other
information related to this action. Although a part of the official
docket, the public docket does not include Confidential Business
Information (CBI) or other information whose disclosure is restricted
by statute. The official public docket is the collection of materials
that is available for public viewing at the Public Information and
Records Integrity Branch (PIRIB), Rm. 119, Crystal Mall 2,
1921 Jefferson Davis Hwy., 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.
2. Electronic access. 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 at http://.
http://www.access.gpo.gov/nara/cfr/cfrhtml_00/Title_40/40cfr180_00.html, a
beta site currently under development.
An electronic version of the public docket is available through
EPA's electronic public docket and comment system, EPA Dockets. You may
use EPA Dockets at http://www.epa.gov/edocket/ to submit or view public
comments, access the index listing of the contents of the official
public docket, and to access those documents in the public docket that
are available electronically. Although not all docket materials may be
available electronically, you may still access any of the publicly
available docket materials through the docket facility identified in
Unit I.B.1. Once in the system, select ``search,'' then key in the
appropriate docket ID number.
II. Background and Statutory Findings
In the Federal Register of July 11, 2003 (68 FR 41351) (FRL-7315-
8), EPA issued a notice pursuant to section 408 of the FFDCA, 21 U.S.C.
346a, as amended by the FQPA (Public Law 104-170), announcing the
filing of amendments to pesticide tolerance petitions (PP 5E4510 and
5E4515) by PURAC America Inc., 111 Barclay Boulevard, Lincolnshire, IL
60069. There were no comments received in response to the notice of
filing.
The petitions requested that 40 CFR 180.950 be amended by
establishing two exemptions from the requirement of a tolerance for
residues of lactic acid, n-butyl ester, (S) and lactic acid, ethyl
ester, (S), CAS Reg. Nos. 34451-19-9 and 687-47-8, respectively. These
are the stereochemical isomers of lactic acid, n-butyl ester and lactic
acid, ethyl ester.
PURAC did not submit any new information as part of the amended
petitions. PURAC is relying on the studies that were submitted in
support of their 1995 petitions.
In response to the original pesticide petitions (5E4510 and 5E4515)
submitted in 1995 by PURAC, EPA established tolerance exemptions for
lactic acid, n-butyl ester and lactic acid, ethyl ester. For a
discussion of the information submitted and the results of the Agency's
review and evaluation, see the Federal Register of September 3, 2002
(67 FR 56225) (FRL-7196-6). In establishing these two tolerance
exemptions, EPA identified the two chemical substances by nomenclature
and CAS Reg. Nos. in what could be termed a general or non-specific
manner. The general CAS Reg. Nos. are correct and do adequately
identify the two lactic acid esters.
PURAC is now requesting that the Agency establish tolerance
exemptions for the (S) isomers of lactic acid, ethyl ester (S) and
lactic acid, n-butyl ester (S). On the PURAC website, the information
for these two chemicals indicates that both chemicals are marketed
under their general CAS Reg. No. and their (S) isomer CAS Reg. No. (see
http://www.purac.com/documents/products/EN-BL.pdf and http://www.purac.com/documents/products/EN-EL.pdf.
Given this information, the
f.
Given this information, the
acid, ethyl ester and lactic acid, n-butyl ester that were established
on September 3, 2002, using the general CAS Reg. Nos.
Section 408(b)(2)(A)(i) of the FFDCA allows EPA to establish an
exemption from the requirement for a tolerance (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) 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) requires EPA to give
special consideration to exposure of infants and children to the
pesticide chemical residue in establishing a tolerance 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. First, EPA determines the
toxicity of pesticides. Second, EPA examines exposure to the pesticide
through food, drinking water, and through other exposures that occur as
a result of pesticide use in residential settings.
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 lactic
acid, n-butyl ester, (S) and lactic acid, ethyl ester, (S) are
discussed in this unit.
As mentioned above, lactic acid, n-butyl ester, (S) and lactic
acid, ethyl ester, (S) are the stereochemical isomers of lactic acid,
n-butyl ester and lactic acid, ethyl ester. In the simplest terms an
isomer can be defined as a substance which has the same molecular
formula as another, but the individual elements of the molecule--the
links from one element to another within the molecule--are arranged
differently. A stereochemical isomer differs in the 3-D spatial
arrangement of the elements. In certain cases, this is sometimes
referred to as ``mirror images.'' An example of such a mirror image
arrangement is a person's right and left hand. A person holding his
hands out, both palms up, cannot make the presentation of four fingers
and the thumb of the right hand match the orientation of the left hand.
They can be viewed as if there is a mirror between the two.
The chemical and physical properties of two isomeric chemicals are
essentially the same. There can be some differences in the biological
properties of the two isomers. However, the studies submitted by PURAC
America Inc. in support of the original petition were performed using
the isomeric form of the lactate esters--the (S) form--that is
manufactured by PURAC. Therefore, the
[[Page 4075]]
data base that was offered in the original petition supports not only
the use of the general nomenclature and the general CAS Reg. No., but
also the (S) isomer nomenclature and the (S) isomer CAS Reg. No.
The Agency's conclusions on toxicity and aggregate exposure based
on the available information as discussed in the Final Rule on
September 3, 2002, remain the same and are applicable to both the
general nomenclature and the (S) isomer nomenclature.
IV. Cumulative Effects
Section 408(b)(2)(D)(v) of the 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.'' EPA does not have, at this
time, available data to determine whether lactic acid, n-butyl ester,
(S); lactic acid, n-butyl ester; lactic acid, ethyl ester, (S); and
lactic acid, ethyl ester have a common mechanism of toxicity with other
substances. 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 as to any lactic
acid esters. These esters do not appear to produce toxic metabolites
produced by other substances. As stated in the Final Rule of September
3, 2002, these are lower toxicity chemicals; therefore, the resultant
risks separately and/or combined should also be low. For the purposes
of this tolerance action, therefore, EPA has not assumed that the
lactic acid esters 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 Office of Pesticide Programs 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/
.
V. Determination of Safety for U.S. Population, Infants and Children
The Agency's determination of safety as discussed in the Final Rule
on September 3, 2002, remains the same and is applicable to both the
general nomenclature and the (S) isomer nomenclature.
VI. 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
lactic acid, n-butyl ester (S) and lactic acid, ethyl ester (S) for
endocrine effects may be required.
B. Analytical Method(s)
No analytical method is required for enforcement purposes since the
Agency is establishing an exemption from the requirement of a tolerance
without any numerical limitation.
C. Existing Tolerances
There are two existing tolerance exemptions for lactic acid, n-
butyl ester, and lactic acid, ethyl ester, using the general CAS Reg.
No. in 40 CFR 180.950. The Agency is not removing these tolerance
exemptions.
D. International Tolerances
The Agency is not aware of any country requiring a tolerance or
tolerance exemption for lactic acid, n-butyl ester, (S) and lactic
acid, ethyl ester, (S).
VII. Conclusions
Based on the information in the record, summarized in this
preamble, and the Final Rule published on September 3, 2002, EPA
concludes that there is a reasonable certainty of no harm from
aggregate exposure to residues of lactic acid, n-butyl ester, (S) and
lactic acid, ethyl ester, (S). Accordingly, EPA finds that exempting
lactic acid, n-butyl ester, (S) (CAS Reg. No. 34451-19-9) and lactic
acid, ethyl ester, (S) (CAS Reg. No. 687-47-8) from the requirement of
a tolerance will be safe.
VIII. Objections and Hearing Requests
Under section 408(g) of the FFDCA, as amended by the 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
the FFDCA by the FQPA, EPA will continue to use those procedures, with
appropriate adjustments, until the necessary modifications can be made.
The new section 408(g) 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), as
was provided in the old FFDCA sections 408 and 409. 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-2003-0341 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 March 29,
2004.
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(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 (1900C),
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 Rm. 104, Crystal Mall 2, 1921
Jefferson Davis Hwy., Arlington, VA. 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
(703) 603-0061.
2. Tolerance fee payment. If you file an objection or request a
hearing, you must also pay the fee prescribed by 40 CFR 180.33(i) or
request a waiver of that
[[Page 4076]]
fee pursuant to 40 CFR 180.33(m). You must mail the fee to: EPA
Headquarters Accounting Operations Branch, Office of Pesticide
Programs, P.O. Box 360277M, Pittsburgh, PA 15251. Please identify the
fee submission by labeling it ``Tolerance Petition Fees.''
EPA is authorized to waive any fee requirement ``when in the
judgement of the Administrator such a waiver or refund is equitable and
not contrary to the purpose of this subsection.'' For additional
information regarding the waiver of these fees, you may contact James
Tompkins by phone at (703) 305-5697, by e-mail at tompkins.jim@epa.gov,
or by mailing a request for information to Mr. Tompkins at Registration
Division (7505C), Office of Pesticide Programs, Environmental
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-
0001.
If you would like to request a waiver of the tolerance objection
fees, you must mail your request for such a waiver to: James Hollins,
Information Resources and Services Division (7502C), Office of
Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania
Ave., NW., Washington, DC 20460-0001.
3. Copies for the Docket. In addition to filing an objection or
hearing request with the Hearing Clerk as described in Unit VIII.A.,
you should also send a copy of your request to the PIRIB for its
inclusion in the official record that is described in Unit I.B.1. Mail
your copies, identified by docket ID number OPP-2003-0341, to: Public
Information and Records Integrity Branch, Information Resources and
Services Division (7502C), Office of Pesticide Programs, Environmental
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460.
In person or by courier, bring a copy to the location of the PIRIB
described in Unit I.B.1. You may also send an electronic copy of your
request via e-mail to: opp-docket@epa.gov. 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(s) in the manner sought
by the requestor would be adequate to justify the action requested (40
CFR 178.32).
IX. Statutory and Executive Order Reviews
This final rule establishes an exemption from the tolerance
requirement under FFDCA section 408(d) 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). Since
tolerances and exemptions that are established on the basis of a
petition under FFDCA section 408(d), such as the exemption 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 FFDCA section 408(n)(4). 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.
X. 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
[[Page 4077]]
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: January 7, 2004.
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.
0
2. In section 180.950, the table in paragraph (e) is amended by adding
alphabetically the following entries to read as follows:
Sec. 180.950 Tolerance exemptions for minimal risk active and inert
ingredients.
* * * * *
(e) * * *
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Chemical Name CAS No.
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* * * * *
Lactic acid, n-butyl ester, (S)...................... 34451-19-9
Lactic acid, ethyl ester,(S)......................... 687-47-8
* * * * *
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* * * * *
[FR Doc. 04-1447 Filed 1-27-04; 8:45 am]
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