[Federal Register: April 2, 2008 (Volume 73, Number 64)]
[Rules and Regulations]
[Page 17910-17914]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr02ap08-11]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[EPA-HQ-OPP-2006-0479; FRL-8347-9]
Ferric Citrate; Inert Ingredient; 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 under 40 CFR 180.910 for residues of ferric citrate (CAS
Reg. No. 2338-05-8) in or on raw agricultural commodities when applied/
used as inert ingredients in pesticide formulations. The Shepherd
Chemical Company submitted a petition to EPA under the Federal Food,
Drug, and Cosmetic Act (FFDCA), as amended by the Food Quality
Protection Act of 1996, requesting an exemption from the requirement of
a tolerance. This regulation eliminates the need to establish a maximum
permissible level for residues of ferric citrate.
DATES: This regulation is effective April 2, 2008. Objections and
requests for
[[Page 17911]]
hearings must be received on or before June 2, 2008, 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-2006-0479. 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: Kathleen Martin, Registration Division
(7505P), Office of Pesticide Programs, Environmental Protection Agency,
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone
number: (703) 308-2857; e-mail address: martin.kathleen@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. To determine
whether you or your business may be affected by this action, you should
carefully examine the applicability provisions in 40 CFR part 152. 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-2006-0479 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 June 2, 2008.
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-2006-0479, 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 June 7, 2006 (71 FR 32955) (FRL-8071-2),
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
6E7062) by The Shepherd Chemical Company, 4900 Beech Street; Norwood,
OH 45212-2398. The petition requested that 40 CFR part 180 be amended
by establishing an exemption from the requirement of a tolerance for
residues of ferric citrate. No comments were received in response to
the notice of filing.
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
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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. Provided below in
Unit III is a brief summary and conclusions for the Agency's review of
ferric citrate. The full Inert Ingredient Decision Document for this
action is available on EPA's Electronic Docket at http://
www.regulations.gov/ under docket number EPA-HQ-OPP-2006-0479.
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 ferric
citrate is discussed in this unit.
The Agency reviewed the available information on ferric citrate and
determined that the toxicity database is sufficient. The toxicity
studies summarized below are from the published literature; their full
references are provided in the Decision Document. In summary, from what
is known about the sulfates of iron (as opposed to the citrate), it
appears that ferric citrate is not acutely toxic via the oral route. In
subchronic toxicity using mice, no effects were noted at the maximum
tolerated dose. In chronic toxicity testing, no effects were seen at
1,200 parts per million (ppm). Ferric citrate has not been shown to be
mutagenic or carcinogenic. Finally, no developmental and reproductive
effects have been shown.
Acute toxicity. No acute toxicity studies per se were identified
for ferric citrate. In 2002 the Agency reassessed the tolerance
exemptions for the mineral acids and their salts. Among the chemicals
assessed were the iron sulfates. Acute toxicity values included: oral
LD50 rat--1,487 to 2,102 milligrams/kilograms (mg/kg); oral
LD50 mice--1,520 mg/kg; and dermal LD50 rabbit--
2,000 mg/kg. The National Academy of Sciences Institute of Medicine
(IOM) discusses reports of acute toxicity resulting from overdoses of
medicinal iron, especially in young children. Accidental iron overdose
is the most common cause of poisoning deaths in children under six
years of age in the U.S. The severity of iron toxicity is related to
the amount of elemental iron absorbed. Gastrointestinal (GI)
manifestations occur following the ingestion of 20 milligrams/kilograms
body weight (mg/kg bw) and systemic toxicity may occur following the
ingestion of 60 mg/kg bw. Vomiting and diarrhea characterize the
initial stages of iron intoxication while later systemic effects can
include those involving the heart, central nervous system, kidney,
liver, and blood. IOM reports that in studies with adults, GI effects
were seen at 50 milligrams/day (mg/day) of elemental iron; this finding
is supported by other studies showing similar effects.
Subchronic toxicity. The open literature reports a study where
ferric citrate was administered to mice in drinking water at doses of
0; 0.06; 0.12; 0.25; 0.5; or 1% (which is equivalent to 0; 600; 1,200;
2,500; 5,000; or 10,000 ppm) for 13 weeks. The investigators determined
that the maximum tolerated dose is 1,200 ppm.
Mutagenicity. The open literature provides results of Ames testing
(with S. typhimurium strains TA92, TA 1535, TA100, TA1537, TA94, and
TA98) and chromosomal aberration testing (with Chinese hamster
fibroblasts). In the Ames test using 25 milligrams/plate (mg/plate) of
ferric citrate (the maximum dose), no significant increases in the
number of revertant colonies were detected in any S. typhimurium
strains. In the chromosomal aberration testing using 0.5 milligrams/
milliLiters (mg/mL) (the maximum dose), polyploidy was observed in 3%
of the cells after 48 hours and structural aberration was observed in
1% of the cells after 48 hours; the investigators concluded that these
results were negative for chromosomal aberration.
Chronic toxicity. In a study reported in the open literature,
ferric citrate was administered to mice in drinking water at doses of
0; 0.06; or 0.12% (which is equivalent to 0; 600 or 1,200 ppm) for 96
weeks. No evidence of chronic toxicity or carcinogenicity was
demonstrated in the study.
Developmental and reproductive toxicity. To determine if toxic
fetal serum iron levels are reached when maternal serum iron
concentrations rise above what the body can homeostatically maintain,
investigators dosed pregnant sheep with toxic doses of iron.
Specifically, four gravid ewes were dosed with ferric chloride at 2 mg/
kg/bw via intravenous administration over 60 minutes; this route was
chosen over the oral route because only a small amount of iron is
absorbed from the gastrointestinal tract after overdose. A significant
rise was observed in the maternal serum iron concentration but not in
that of the fetuses. The investigators concluded that the fetus is
protected from elevated maternal serum iron concentrations during the
third trimester of pregnancy, a period when the fetus acquires most of
the iron that it needs during the gestational period.
IV. Aggregate Exposures
In examining aggregate exposure, FFDCA section 408 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).
EPA does not have information available to assess the potential for
exposure to ferric citrate in consumer products. Nevertheless, given:
The natural and ubiquitous occurrence of iron-containing compounds in
the environment; iron's known role in human physiology; and its
presence in various foods such as beef, soybeans, lentils, and spinach,
it is unlikely that residential exposures of concern would result from
the use of ferric citrate in nonpesticide products and as an ingredient
in pesticide. Therefore, no further aggregate assessment is necessary.
Dietary Exposure Food. EPA estimated dietary exposures for use of
ferric citrate as an inert ingredient using DEEM\(tm)\, or Dietary
Exposure Evaluation Model, a generic screening model that assumes that
the inert ingredient is used on all commodities and that 100 percent of
crops are treated with the inert ingredient. Generic chronic exposure
for the overall U.S. population was estimated at 0.12 mg/kg/day.
2. Drinking water exposure. Iron concentrations in groundwater have
been reported to range <0.5 to 100 mg/L; higher values have been found
in the absence of oxygen and in the presences of organic matter. In
surface waters, iron concentrations can vary widely, ranging from 61 to
2,680 milligrams/Liters (mg/L).
V. Cumulative Effects
Section 408(b)(2)(D)(v) of FFDCA requires that, when considering
whether to establish, modify, or revoke a tolerance, the Agency
consider
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``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 ferric citrate and any
other substances and, this material 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 ferric citrate
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 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/.
VI. Determination of Safety for U.S. Population, Infants and Children
Based on the information in this preamble, EPA concludes that there
is a reasonable certainty of no harm from aggregate exposure to
residues. Accordingly, EPA finds that exempting from the requirement of
a tolerance will be safe.
VII. Other Considerations
A. Analytical Method
An analytical method is not required for enforcement purposes since
the Agency is establishing an exemption from the requirement of a
tolerance without any numerical limitation.
B. International Tolerances
The Agency is not aware of any country requiring a tolerance for
ferric citrate (CAS Reg. No. 2338-05-8), nor have any CODEX Maximum
Residue Levels (MRLs) been established for any food crops at this time.
VIII. 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 6, 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).
IX. 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: March 21, 2008.
Lois Rossi,
Director, Registration Division, Office of Pesticide Programs.
0
Therefore, 40 CFR chapter I is amended as follows:
PART 180--[AMENDED]
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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. 180.910 the table is amended by adding alphabetically the
following inert ingredient to read as follows:
Sec. 180.910 Inert ingredients used pre- and post-harvest; exemptions
from the requirement of a tolerance.
* * * * *
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Inert ingredients Limits Uses
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* * * * * * *
Ferric Citrate (CAS Reg. No. .................. Stabilizer
2338-05-8)
* * * * * * *
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[FR Doc. E8-6818 Filed 4-1-08; 8:45 am]
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