[Federal Register Volume 69, Number 18 (Wednesday, January 28, 2004)]
[Rules and Regulations]
[Pages 4073-4077]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-1447]


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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: 
[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.

[[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://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 
Agency does not intend to remove the tolerance exemptions for lactic 
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 [email protected], 
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: [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(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) * * *

------------------------------------------------------------------------
                    Chemical Name                           CAS No.
------------------------------------------------------------------------
                                * * * * *
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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