[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]


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

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.

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

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

[[Page 56105]]

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