[Federal Register Volume 62, Number 209 (Wednesday, October 29, 1997)]
[Rules and Regulations]
[Pages 56102-56105]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-28657]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[OPP-300564; FRL-5749-2]
RIN 2070-AB78
Ferric Phosphate; Establishment of an Exemption from the
Requirement of a Tolerance
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final Rule.
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SUMMARY: This rule establishes an exemption from the requirement of a
tolerance for residues of ferric phosphate, when used as a molluscicide
in or on all food commodities. W. Neudorff GmbH KG submitted a petition
to EPA under the Federal Food, Drug and Cosmetic Act (FFDCA) as amended
by the Food Quality Protection Act (FQPA) of 1996 requesting the
exemption from the requirement of a tolerance. This regulation
eliminates the need to establish a maximum permissible level for
residues of this molluscicide in or on all food commodities.
DATES: This regulation is effective on October 29, 1997. Objections and
requests for hearings must be received by December 29, 1997.
ADDRESSES: Written objections and hearing requests, identified by the
docket control number [OPP-300564], must be submitted to: Hearing Clerk
(1900), Environmental Protection Agency, Rm. M3708, 401 M St., SW.,
Washington, DC 20460. Fees accompanying objections and hearing requests
shall be labeled ``Tolerance Petition Fees'' and forwarded to: EPA
Headquarters Accounting Operations Branch, OPP (Tolerance Fees), P.O.
Box 360277M, Pittsburgh, PA 15251. A copy of any objections and hearing
requests filed with the Hearing Clerk identified by the docket control
number, [OPP-300564], must also be submitted to: Public Information and
Records Integrity Branch, Information Resources and Services Division
(7502C), Office of Pesticide Programs, Environmental
[[Page 56103]]
Protection Agency, 401 M St., SW., Washington, DC 20460. In person,
bring a copy of objections and hearing requests to Rm. 1132, CM #2,
1921 Jefferson Davis Hwy., Arlington, VA.
A copy of objections and hearing requests filed with the Hearing
Clerk may be submitted electronically by sending electronic mail (e-
mail) to: [email protected]. Copies of electronic objections
and hearing requests must be submitted as an ASCII file avoiding 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 5.1/6.1 or ASCII file format. All copies of
electronic objections and hearing requests must be identified by the
docket number [OPP-300564]. No Confidential Business Information (CBI)
should be submitted through e-mail. Copies of electronic objections and
hearing requests on this rule may be filed online at many Federal
Depository Libraries.
FOR FURTHER INFORMATION CONTACT: By mail: Sheryl K. Reilly, c/o Product
Manager (PM) 90, Biopesticides and Pollution Prevention Division
(7511W), Office of Pesticide Programs, Environmental Protection Agency,
401 M St., SW., Washington, DC 20460, Office location, telephone
number, and e-mail address: CS1 Rm. 5-W31, 2800 Crystal Drive,
Arlington, VA, 703-308-8265, e-mail: [email protected].
SUPPLEMENTARY INFORMATION: W. Neudorff GmbH KG, c/o Walter G. Telarek,
PC, 1008 Riva Ridge Drive, Great Falls, VA, has requested in pesticide
petition PP 7F4804 the establishment of an exemption from the
requirement of a tolerance for residues of the molluscicide iron
(ferric) phosphate. A notice of filing (FRL-5721-6) was published in
the Federal Register (62 FR 32331-32336) on June 13, 1997, and the
notice announced that the comment period would end on July 13, 1997; no
comments were received.
This exemption from the requirement of a tolerance will permit the
marketing of raw agricultural commodities when treated in accordance
with EPA Reg No. 67702-3, which is being issued under the Federal
Insecticide, Fungicide, and Rodenticide Act (FIFRA), as amended (Pub.
L. 95-396, 92 Stat. 819; 7 U.S.C. 136).
The data submitted in the petition and all other relevant material
have been evaluated. The following is a summary of EPA's findings
regarding this petition.
I. Product Identity
NEU 1165M Slug and Snail Bait (EPA file symbol No. 067702-G) is the
first pesticide product containing the active ingredient ferric
phosphate (FePO4, CAS# 11045-86-0). The product contains the
active ingredient at a concentration of 1% incorporated into a solid
matrix, which is odorless, and has a white-to-buff color.
II. Risk Assessment and Statutory Findings
New section 408(c)(2)(A)(i) of FFDCA allows EPA to establish an
exemption from the requirement of 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)(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(c)(2)(B) 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
scientific data and other relevant information in support of this
action and considered its validity, completeness, reliability, and
relationship 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.
A battery of acute toxicity studies place NEU 1165M Slug and Snail
Bait in the following Toxicity Categories: Acute Oral (Toxicity
Category IV); Acute Dermal (Toxicity Category IV; Primary Eye
Irritation (Toxicity Category III); and Primary Dermal Irritation
(Toxicity Category IV). (MRIDs 440427-04,-05, -06, and -07)
Data waivers were requested for acute inhalation toxicity, dermal
sensitization, genotoxicity, reproductive and developmental toxicity,
subchronic (90-day) oral toxicity, and chronic toxicity. The waivers
were accepted based on the long history of use of iron and iron salts
by humans without any indication of deleterious effects, and on the
following:
The toxicity of ferric phosphate is low; ferric phosphate occurs
naturally as a mineral, and is added to food, such as bread, for
nutritional fortification. Iron is an essential nutrient for humans and
all other vertebrates; the average human diet contains 10-15 mg of iron
a day. Ferric phosphate is also sometimes used as a fertilizer. In
addition, iron is found in abundance in nature; the low water-
solubility of ferric phosphate limits its absorption across the
intestinal epithelium.
IV. Residue Chemistry
A waiver was requested and granted for magnitude of the residue
anticipated at the time of harvest and method used to determine the
residue data requirements based on ferric phosphate's (1) low toxicity,
(2) natural occurrence, (3) abundance in the environment, (4)
widespread use as human nutrient and dietary supplements and in infant
formula, (5) status at FDA as ``generally recognized as safe'' (GRAS),
and (6) data available in the open literature.
V. Aggregate Exposure
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. The primary
non-food sources of exposure the Agency considers include drinking
water or groundwater, and exposure through pesticide use in gardens,
lawns, or buildings (residential and other indoor uses).
1. Dietary exposure. Dietary exposure of ferric phosphate via food
or water exists due to its use as a nutritional supplement and its
ubiquitous presence in nature. Residues from use of the biochemical
pesticide, ferric phosphate, will not significantly add to the current
dietary exposures.
2. Non-dietary, non-occupational exposure. Increased non-dietary
exposure of ferric phosphate via non-commercial greenhouse, home lawn
and garden or ornamental use will be minimal. Exposure by the
inhalation route would be non-existent because
[[Page 56104]]
ferric phosphate is not volatile and the formulation of the product is
a solid matrix of non-respirable size. In summary, the potential
aggregate exposure, derived from non-dietary and non-occupational
exposure should be minimal.
VI. Cumulative Effects
Ferric phosphate has a very low toxicity to humans. Because of its
low toxicity, low rate of application, and use patterns, the Agency
believes that there is no reason to expect any cumulative effects from
ferric phosphate and other substances.
VII. Endocrine Disruptors
The Agency has no information to suggest that ferric phosphate has
any effect on the immune and endocrine systems. The Agency is not
requiring information on the endocrine effects of this biochemical
pesticide at this time; Congress has allowed 3 years after August 3,
1996, for the Agency to implement a screening program with respect to
endocrine effects. Nevertheless, the above discussion on exposure from
all sources combined with the low toxicity of ferric phosphate would
indicate such testing would not be necessary.
VIII. Safety Determination for U.S. Population, Infants and
Children
Based on the information discussed above, EPA concludes that there
is reasonable certainty that no harm will result from aggregate
exposure to the U.S. population, including infants and children, to
residues of ferric phosphate. This includes all anticipated dietary
exposures and all other exposures for which there is reliable
information. The Agency has arrived at this conclusion because, as
discussed above, the toxicity of ferric phosphate to mammals is very
low and under reasonably foreseeable circumstances it does not pose a
risk.
FFDCA section 408 provides that EPA shall apply an additional
tenfold margin of exposure (safety) for infants and children in the
case of threshold effects to account for pre- and post-natal toxicity
and the completeness of the database, unless EPA determines that a
different margin of exposure (safety) will be safe for infants and
children. Margins of exposure (safety) are often referred to as
uncertainty (safety) factors. In this instance, the Agency believes
there is reliable data to support the conclusion that ferric phosphate
is practically non-toxic to mammals, including infants and children,
and, thus, there are no threshold effects, and EPA has not used a
margin of exposure (safety) approach to assess the safety of ferric
phosphate. As a result, the provision requiring an additional margin of
exposure (safety) does not apply.
IX. Other Considerations
1. Analytical method. The Agency proposes to establish an exemption
from the requirement of a tolerance without any numerical limitation;
therefore, the Agency has concluded that an analytical method is not
required for enforcement purposes for ferric phosphate residues.
2. Codex maximum residue level. There are no CODEX tolerances nor
international tolerance exemptions for ferric phosphate at this time.
X. Conclusion
Based on the information discussed above, EPA establishes an
exemption from the requirement of a tolerance pursuant to FFDCA section
408(j)(3) for ferric phosphate.
This exemption from the requirement of a tolerance will be revoked
if any experience with or scientific data on this pesticide indicate
that the tolerance is not safe.
XI. Objections and Hearing Requests
The new FFDCA section 408(g) provides essentially the same process
for persons to ``object'' to a tolerance exemption regulation issued by
EPA under new section 408(e) as was provided in the old section 408.
However, the period for filing objections is 60 days, rather than 30
days. EPA currently has procedural regulations which govern the
submission of objections and hearing requests. These regulations will
require some modification to reflect the new law. However, until those
modifications can be made, EPA will continue to use those procedural
regulations with appropriate adjustments to reflect the new law.
Any person adversely affected by this regulation may, on or before
December 29, 1997, file written objections to the regulation and may
also request a hearing on those objections. Objections and hearing
requests must be filed with the Hearing Clerk, at the address given
above (40 CFR 178.20). A copy of the objections and/or hearing requests
filed with the Hearing Clerk should be submitted to the OPP docket for
this rulemaking. The objections submitted must specify the provisions
of the regulation deemed objectionable and the grounds for the
objections (40 CFR 178.25). Each objection must be accompanied by the
fee prescribed by 40 CFR 180.33(i). If a hearing is requested, the
objections must include a statement of the factual issue(s) on which a
hearing is requested, the requestor's contentions on such issues, and a
summary of any evidence relied upon by the objector (40 CFR 178.27). A
request for a hearing will be granted if the Administrator determines
that the material submitted shows the following: There is genuine and
substantial issue of fact; there is reasonable possibility that
available evidence identified by the requestor would, if established,
resolve one or more of such issues in favor of the requestor, taking
into account uncontested claims or facts to the contrary; and
resolution of the factual issue(s) in the manner sought by the
requestor would be adequate to justify the action requested (40 CFR
178.32). 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.
XII. Public Record and Electronic Submissions
EPA has established a record for this rulemaking under docket
control number [OPP-300564] (including any comments and data submitted
electronically). A public version of this record, including printed,
paper versions of electronic comments, which does not include any
information claimed as CBI, is available for inspection from 8:30 a.m.
to 4 p.m., Monday through Friday, excluding legal holidays. The public
record is located in Room 1132 of the Public Information and Records
Integrity Branch, Information Resources and Services Division (7502C),
Office of Pesticide Programs, Environmental Protection Agency, Crystal
Mall #2, 1921 Jefferson Davis Highway, Arlington, VA.
Electronic comments may be sent directly to EPA at:
[email protected].
Electronic comments must be submitted as an ASCII file avoiding the
use of special characters and any form of encryption.
The official record for this rulemaking, as well as the public
version, as described above will be kept in paper form. Accordingly,
EPA will transfer any copies of objections and hearing requests
received electronically into printed, paper form as they are received
and will place the paper copies in the official rulemaking record which
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will also include all comments submitted directly in writing. The
official rulemaking record is the paper record maintained at the
Virginia address in ``ADDRESSES'' at the beginning of this document.
XIII. Regulatory Assessment Requirements
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). 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) (Pub. L. 104-4). Nor does it require any
prior consultation as specified by Executive Order 12875, entitled
Enhancing the Intergovernmental Partnership (58 FR 58093, October 28,
1993), or special considerations as required by Executive Order 12898,
entitled Federal Actions to Address Environmental Justice in Minority
Populations and Low-Income Populations (59 FR 7629), February 16,
1994), or require OMB review in accordance with Executive Order 13045,
entitled Protection of Children from Environmental Health Risks and
Safety Risks (62 FR 19885, April 23, 1997).
In addition, since tolerance 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. Nevertheless, the Agency previously assessed
whether establishing tolerances, exemptions from tolerances, raising
tolerance levels or expanding exemptions might adversely impact small
entities and concluded, as a generic matter, that there is no adverse
economic impact. The factual basis for the Agency's generic
certification for tolerance actions published on May 4, 1981 (46 FR
24950), and was provided to the Chief Counsel for Advocacy of the Small
Business Administration.
XIV. Submission to Congress and the General Accounting Office
Under 5 U.S.C. 801(a)(1)(A), as added by the Small Business
Regulatory Enforcement Fairness Act of 1996, the Agency has submitted 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 General Accounting Office prior to publication of the rule in
today's Federal Register. This 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 21, 1997.
Stephen L. Johnson,
Acting Director, Office of Pesticide Programs.
Therefore, 40 CFR chapter I is amended as follows:
PART 180--[AMENDED]
1. The authority citation for part 180 continues to read as
follows:
Authority: 21 U.S.C. 346a and 371
2. Section 180.1191 is added to subpart D to read as follows:
Sec. 180.1191 Ferric phosphate; exemption from the requirement of a
tolerance.
An exemption from the requirement of a tolerance is established for
residues of the biochemical pesticide, ferric phosphate
(FePO4, CAS No. 11045-86-0) in or on all food commodities.
[FR Doc. 97-28657 Filed 10-28-97; 8:45 am]
BILLING CODE 6560-50-F