Document ID: EPA-HQ-OPP-2008-0250-0001
Agency: epa
Document Type: Rule
Title: Inert Ingredient: Exemption from the Requirement of a Tolerance for (S,S)-Ethylenediaminedisuccinic Acid
Posted Date: 2008-11-14T05:00Z

[Federal Register: November 14, 2008 (Volume 73, Number 221)]
[Rules and Regulations]               
[Page 67397-67400]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr14no08-18]                         

-----------------------------------------------------------------------

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2008-0250; FRL-8362-4]

 
Inert Ingredient: Exemption from the Requirement of a Tolerance 
for (S,S)-Ethylenediaminedisuccinic Acid

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

-----------------------------------------------------------------------

SUMMARY: This regulation establishes an exemption from the requirement 
of a tolerance for residues of (S,S)-Ethylenediaminedisuccinic acid 
(CAS Reg. No. 20846-91-7) ((S,S)-EDDS) when used as an inert ingredient 
sequestrant or chelating agent in pesticide formulations applied to 
growing crops only under 40 CFR 180.920. Associated Octel Company, 
Limited, 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. This regulation eliminates the need to establish a maximum 
permissible level for residues of (S,S)-Ethylenediaminedisuccinic acid.

DATES: This regulation is effective November 14, 2008. Objections and 
requests for hearings must be received on or before January 13, 2009, 
and must be filed in accordance with the instructions provided in 40 
CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).

ADDRESSES: EPA has established a docket for this action under docket 
identification (ID) number EPA-HQ-OPP-2008-0250. To access the 
electronic docket, go to http://www.regulations.gov, select ``Advanced 
Search,'' then ``Docket Search.'' Insert the docket ID number where 
indicated and select the ``Submit'' button. Follow the instructions on 
the regulations.gov website to view the docket index or access 
available documents. All documents in the docket are listed in the 
docket index available in regulations.gov. Although listed in the 
index, some information is not publicly available, e.g., 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 in the electronic docket at http://
www.regulations.gov, or, if only available in hard copy, at the Office 
of Pesticide Programs (OPP) Regulatory Public Docket in Rm. S-4400, One 
Potomac Yard (South Bldg.), 2777 S. Crystal Dr., Arlington, VA. The 
hours of operation of this Docket Facility are from 8:30 a.m. to 4 
p.m., Monday through Friday, excluding legal holidays. The Docket 
Facility telephone number is (703) 305-5805.

FOR FURTHER INFORMATION CONTACT: Karen Samek, Registration Division 
(7505P), Office of Pesticide Programs, Environmental Protection Agency, 
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone 
number: (703) 347-8825; e-mail address: samek.karen@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

[[Page 67398]]

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?

    In addition to accessing an electronic copy of this Federal 
Register document through the electronic docket at http://
www.regulations.gov, you may access this Federal Register document 
electronically through the EPA Internet under the ``Federal Register'' 
listings at http://www.epa.gov/fedrgstr. You may also access a 
frequently updated electronic version of 40 CFR part 180 through the 
Government Printing Office's pilot e-CFR site at http://
www.gpoaccess.gov/ecfr.

C. Can I File an Objection or Hearing Request?

    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. You must file your objection or request a hearing on 
this regulation in accordance with the instructions provided in 40 CFR 
part 178. To ensure proper receipt by EPA, you must identify docket ID 
number EPA-HQ-OPP-2008-0250 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 January 13, 2009.
    In addition to filing an objection or hearing request with the 
Hearing Clerk as described in 40 CFR part 178, please submit a copy of 
the filing that does not contain any CBI for inclusion in the public 
docket that is described in ADDRESSES. Information not marked 
confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA 
without prior notice. Submit your copies, identified by docket ID 
number EPA-HQ-OPP-2008-0250, by one of the following methods:
    Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the on-line instructions for submitting comments.
    Mail: Office of Pesticide Programs (OPP) Regulatory Public 
Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania 
Ave., NW., Washington, DC 20460-0001.
    Delivery: OPP Regulatory Public Docket (7502P), 
Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South 
Bldg.), 2777 S. Crystal Dr., Arlington, VA. Deliveries are only 
accepted during the Docket's normal hours of operation (8:30 a.m. to 4 
p.m., Monday through Friday, excluding legal holidays). Special 
arrangements should be made for deliveries of boxed information. The 
Docket Facility telephone number is (703) 305-5805.

II. Background and Statutory Findings

    In the Federal Register of January 19, 2005 (70 FR 3026) (FRL-7690-
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 tolerance 
petition (PP 4E6818) by Associated Octel Company, Limited, P.O. Box 17, 
Oil Sites Road, Ellesmere Port, South Wirral L65 4HF, United Kingdom. 
The petition requested that 40 CFR 180.920 be amended by establishing 
an exemption from the requirement of a tolerance for residues of (S,S)-
Ethylenediaminedisuccinic acid (CAS Reg. No. 20846-91-7) when used as 
an inert ingredient sequestrant or chelating agent in pesticide 
formulations. That notice provided a summary of studies summated by the 
petitioner, Associated Octel Company, Limited. There were no comments 
received in response to the notice of filing. For ease of reading in 
this document, (S,S)-Ethylenediaminedisuccinic acid is referred to as 
(S,S)-EDDS.
    Section 408(c)(2)(A)(i) of 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(c)(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. Pursuant to section 408(c)(2)(B) of FFDCA, in 
establishing or maintaining in effect an exemption from the requirement 
of a tolerance, EPA must take into account the factors set forth in 
section 408(b)(2)(C) of FFDCA, which 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. Toxicological Profile

    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 (S,S)-
EDDS are discussed in this unit.
    The following provides a brief summary of the risk assessment and 
conclusions for the Agency's review of (S,S)-EDDS. The Agency's full 
decision document for this action is available in EPA's Electronic 
Docket at http://www.regulations.gov under docket number EPA-HQ-OPP-
2007-0250.
    Studies show that (S,S)-EDDS has low acute and subchronic toxicity, 
is a mild eye irritant, and is not a dermal irritant or skin 
sensitizer. Based on the results of submitted mutagenicity studies, 
(S,S)-EDDS is not likely to be mutagenic. No carcinogenicity studies 
are available on (S,S)-EDDS, however, NTP tested trisodium EDTA in mice 
and rats showed no carcinogenic potential. Based on its similarity with 
EDTA and lack of mutagenicity, (S,S)-EDDS is not likely to be 
carcinogenic to humans at low doses. In addition, metabolism studies 
show that (S,S)-EDDS is poorly absorbed but rapidly excreted within 72 
hours.
    The (S,S)-EDDS studies indicate developmental toxicity only at high 
dosage levels that resulted in maternal toxicity (limit dose levels). 
In a developmental toxicity study in rats, the maternal toxicity LOAEL 
is 944.1 milligrams/kilograms, body weight/day (mg/kg bw/day) (16,000 
ppm) (limit dose) based on reductions in body weight, body weight gain, 
feed consumption, and blood levels of zinc, iron, and copper, and the 
NOAEL is 551.1 mg/kg bw/day (8,000 ppm). The developmental toxicity 
LOAEL is 944.1

[[Page 67399]]

mg/kg bw/day (16,000 ppm) (limit dose) was manifested as an increase in 
fetal death, reduced fetal growth, and multiple developmental 
malformations and variations affecting almost all major organ systems 
and skeletal structures, and the NOAEL is 551.1 mg/kg bw/day (8,000 
ppm). Therefore, the maternal and developmental NOAEL are both 551.1 
mg/kg bw/day (8,000 ppm). The results of this dietary study indicate 
qualitative evidence of increased susceptibility, however, the concern 
for this increased susceptibility is low for the reasons discussed in 
Unit VII.

IV. Aggregate Exposures

    In examining aggregate exposure, section 408 of FFDCA directs EPA 
to consider available information concerning exposures from the 
pesticide residue in food and all other non-occupational exposures, 
including drinking water from ground water or surface water and 
exposure through pesticide use in gardens, lawns, or buildings 
(residential and other indoor uses).
    There are no data provided on (S,S)-EDDS residues in food or on 
non-occupational exposures to (S,S)-EDDS. In the absence of actual 
residue data for (S,S)-EDDS, the Agency performed a dietary (food and 
drinking water) exposure assessment for (S,S)-EDDS in which it was 
assumed that (a) (S,S)-EDDS would be used as an inert ingredient in all 
food use pesticide formulations, applied to all crops; (b) one hundred 
percent of all food crops would be treated with pesticides containing 
(S,S)-EDDS; (c) (S,S)-EDDS residues would be present in all crops at 
levels equal to or exceeding the highest established tolerance levels 
for any pesticide active ingredient, and (d) (S,S)-EDDS would be 
present in all sources of drinking water at concentrations equal to the 
highest established standards for drinking water contaminants 
established by EPA.
    This approach is highly conservative as it is extremely unlikely 
that (S,S)-EDDS would have such use as a pesticide product inert 
ingredient and be present in food commodities and drinking water at 
such high levels. In addition, this highly conservative exposure 
assessment is protective of any possible non-occupational exposures to 
(S,S)-EDDS as it results in exposure estimates orders of magnitude 
greater than the high-end exposure estimates for residential uses of 
pesticides routinely used by EPA.

V. 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.'' 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 (S,S)-EDDS and any other substances, and the chemical 
does not appear to produce a toxic metabolite produced by other 
substances. For the purposes of this tolerance action, therefore, EPA 
has not assumed that (S,S)-EDDS has 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 EPA's website at http://
www.epa.gov/pesticides/cumulative.

VI. Additional Safety Factor for the Protection of Infants and Children

    Section 408 of the FFDCA provides that EPA shall apply an 
additional tenfold margin of safety for infants and children in the 
case of threshold effects to account for pre-natal and post-natal 
toxicity and the completeness of the database on toxicity and exposure 
unless EPA determines that a different margin of safety will be safe 
for infants and children. EPA concluded that the FQPA safety factor 
could be removed for (S,S)-EDDS for the following reasons:
    1. EPA has sufficient data to assess the toxicity of (S,S)-EDDS. 
Although the toxicological database on (S,S)-EDDS is limited, adequate 
long term studies are available on structurally related compounds such 
as calcium disodium EDTA, and trisodium EDTA. Based on the structural 
similarities in these compounds, EPA concluded the database for (S,S)-
EDDS is adequate.
    2. EPA has low concern regarding the potential developmental 
effects of (S,S)-EDDS. The (S,S)-EDDS studies indicate developmental 
toxicity only at high dosage levels that resulted in maternal toxicity 
(limit dose levels). In a developmental toxicity study in rats, the 
maternal toxicity LOAEL is 944.1 mg/kg bw/day (16,000 ppm) (limit dose) 
based on reductions in body weight, body weight gain, feed consumption, 
and blood levels of zinc, iron, and copper, and the NOAEL is 551.1 mg/
kg bw/day (8,000 ppm). The developmental toxicity LOAEL is 944.1 mg/kg 
bw/day (16,000 ppm) (limit dose) was manifested as an increase in fetal 
death, reduced fetal growth, and multiple developmental malformations 
and variations affecting almost all major organ systems and skeletal 
structures, and the NOAEL is 551.1 mg/kg bw/day (8,000 ppm). Therefore, 
the maternal and developmental NOAEL are both 551.1 mg/kg bw/day (8,000 
ppm). The results of this dietary study indicate qualitative evidence 
of increased susceptibility, however, the concern for this increased 
susceptibility is low because:
    i. Effects were seen only at the limit dose and in the presence of 
maternal toxicity.
    ii. There is a well characterized NOAEL (551.1 mg/kg/day) 
protecting from these effects.
    iii. The presence of zinc, iron and copper may have contributed to 
the observed developmental toxicity, since other chelating agents (such 
as EDTA) have been shown to impact zinc, iron, and copper levels and 
some of the developmental toxicity.
    iv. The results were not reproduced in a concurrently conducted 
gavage study in rats at doses up to 1,000 mg/kg/day.
    3. In the absence of actual exposure data on (S,S)-EDDS, a highly 
conservative exposure estimate was utilized thereby reducing 
uncertainty associated with exposures by infants and children to (S,S)- 
EDDS.

VII. Determination of Safety for U.S. Population, Infants, and Children

    EPA determines whether pesticide chemical exposures are safe by 
comparing aggregate exposure estimates to the dose at which no adverse 
effects were seen in the most sensitive animal studies. In the case of 
(S,S)-EDDS, the estimated exposures are compared to a dose level equal 
of 551.1 mg/kg/day derived from the rat developmental toxicity study. 
Utilizing the highly conservative aggregate exposure assessment 
discussed in Unit IV of this document, EPA has concluded that aggregate 
exposures to (S,S)-EDDS are more than three orders of magnitude less 
than the dose at which no adverse effects were seen in the most 
sensitive animal study, and therefore, are below the level of concern 
for the entire U.S. population, including infants and children.
    Based on this risk assessment, EPA concludes that there is a 
reasonable certainty of no harm to the general population, including 
infants and children, from aggregate exposure to residues of (S,S)-
EDDS. Accordingly, EPA finds that the tolerance exemption under 40 CFR 
180.920 for residues of (S,S)-EDDS will be safe and is granting the 
requested tolerance exemption.

[[Page 67400]]

VIII. Other Considerations

A. Analytical Method

    An analytical method is not required for enforcement purposes 
because the Agency is establishing an exemption from the requirement of 
a tolerance without any numerical limitation.

B. International Tolerances

    There are no known international tolerances for residues of (S,S)-
EDDS in food or animal feed.

IX. Statutory and Executive Order Reviews

    This final rule establishes a tolerance 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 final rule has been 
exempted from review under Executive Order 12866, this final 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) or Executive Order 13045, entitled Protection of 
Children from Environmental Health Risks and Safety Risks (62 FR 19885, 
April 23, 1997). 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., 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).
    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.
    This final rule directly regulates growers, food processors, food 
handlers, and food retailers, not States or tribes, nor does this 
action alter the relationships or distribution of power and 
responsibilities established by Congress in the preemption provisions 
of section 408(n)(4) of FFDCA. As such, the Agency has determined that 
this action will not have a substantial direct effect on States or 
tribal governments, on the relationship between the national government 
and the States or tribal governments, or on the distribution of power 
and responsibilities among the various levels of government or between 
the Federal Government and Indian tribes. Thus, the Agency has 
determined that Executive Order 13132, entitled Federalism (64 FR 
43255, August 10, 1999) and Executive Order 13175, entitled 
Consultation and Coordination with Indian Tribal Governments (65 FR 
67249, November 9, 2000) do not apply to this final rule. In addition, 
this final rule does not 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).
    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).

X. Congressional Review Act

    The Congressional Review Act, 5 U.S.C. 801 et seq., generally 
provides that before a rule may take effect, the agency promulgating 
the rule must submit a rule report 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: October 31, 2008.
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. In Sec.  180.920, the table is amended by adding alphabetically the 
following inert ingredient to read as follows:

Sec.  180.920  Inert ingredients used pre-harvest; exemptions from the 
requirement of a tolerance.

* * * * *

------------------------------------------------------------------------
        Inert ingredients               Limits               Uses
------------------------------------------------------------------------
                                * * * * *
 (S,S)-Ethylenediaminedisuccinic                      Sequestrant or
 acid (CAS Reg. No. 20846-91-7)                        chelating agent
                                * * * * *
------------------------------------------------------------------------

[FR Doc. E8-26973 Filed 11-13-08; 8:45 am]

BILLING CODE 6560-50-S