[Federal Register Volume 61, Number 216 (Wednesday, November 6, 1996)]
[Proposed Rules]
[Pages 57356-57359]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-28421]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[OPP-300440; FRL-5572-2]
RIN 2070-AC18
Sodium Bicarbonate and Potassium Bicarbonate; Tolerance
Exemptions
AGENCY: Environmental Protection Agency (EPA).
ACTION: Proposed Rule.
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SUMMARY: EPA proposes to establish exemptions from the requirement of a
tolerance for residues of the biochemical pesticides sodium bicarbonate
and potassium bicarbonate in or on all raw agricultural commodities
(RACs), when applied as fungicides or post-harvest fungicides in
accordance with good agricultural practices. EPA is proposing this
regulation on its own initiative.
DATES: Comments, identified by the docket number [OPP-300440], must be
received on or before December 6, 1996.
ADDRESSES: By mail, submit written comments to: Public Response and
Program Resources Branch, Field Operations Division (7506C), Office of
Pesticide Programs, Environmental Protection Agency, 401 M. St., SW.,
Washington, DC 20460. In person deliver comments to: Rm. 1132, Crystal
Mall #2, 1921 Jefferson Davis Highway, Arlington, VA 22202. Information
[[Page 57357]]
submitted as a comment concerning this document may be claimed
confidential by marking any part or all of that information as
``Confidential Business Information'' (CBI). Information so marked will
not be disclosed except in accordance with procedures set forth in 40
CFR part 2. A copy of the comment that does not contain CBI must be
submitted for inclusion in the public record. Information not marked
confidential will be included in the public docket by EPA without prior
notice. The public docket is available for public inspection in Rm.
1132 at the address given above, from 8 a.m. to 4:30 p.m., Monday
through Friday, excluding legal holidays.
Comments and data may also be submitted electronically by sending
electronic mail (e-mail) to: [email protected]. Electronic
comments must be submitted as an ASCII file avoiding the use of special
characters and any form of encryption. Comments and data will also be
accepted on disks in WordPerfect in 5.1 file format or ASCII file
format. All comments and data in electronic form must be identified by
the docket number, [OPP-300440]. No CBI should be submitted through e-
mail. Electronic comments on this proposed rule may be filed online at
many Federal Depository Libraries. Additional information on electronic
submissions can be found below in this document.
FOR FURTHER INFORMATION CONTACT: By mail: Denise Greenway, c/o Product
Manager (PM) 90, Biopesticides and Pollution Prevention Division
(7501W), Environmental Protection Agency, 401 M St., SW., Washington,
DC 20460. Office location and telephone number: Rm. 5-W57, CSI, 2800
Crystal Drive, Arlington, VA 22202. (703) 308-8263; e-mail:
[email protected].
SUPPLEMENTARY INFORMATION: In the Federal Register of October 25, 1995
(60 FR 54689), EPA issued a notice (FRL-4982-4) that the Meiji Milk
Products Co., Ltd., 2-Chome, Kyabashi Chuoku, Tokyo, Japan 250
(represented by Stewart Pesticide Registration Associates, Inc. of 1901
North Moore Street, Suite 603, Arlington, VA 22209), had submitted
pesticide petition (PP) 5F4481 to EPA proposing to amend 40 CFR part
180 by establishing a regulation pursuant to section 408 of the Federal
Food, Drug and Cosmetic Act (FFDCA), 21 U.S.C. 346a(d), to exempt from
the requirement of a tolerance the residues of the biochemical
pesticide sodium bicarbonate in or on citrus when applied as a
fungicide in accordance with good agricultural practices. There were no
comments received in response to this notice of filing. Another
company, Church and Dwight Co., Inc., obtained registration of the
active ingredients sodium bicarbonate and potassium bicarbonate on
December 20, 1994 as manufacturing products for formulating into
fungicides to control powdery mildew and other fungal diseases of food
and non-food crops. The Agency concluded that the historical knowledge
of the effects of sodium bicarbonate and potassium bicarbonate on
humans and the environment was adequate to allow the waiver of all data
requirements. The Meiji Milk Products Co., Ltd. Pesticide Petition (PP
5F4481) was filed because associated registration applications from
that company represent the first fungicidal food use sodium bicarbonate
end-use products.
The Agency is making this proposal upon its own initiative to
expand the tolerance exemption originally sought by Meiji Milk Products
Co., Ltd. to 1) include the related compound, potassium bicarbonate,
and 2) to permit pre-harvest and post-harvest use of both active
ingredients in or on all raw agricultural commodities. This document
represents an EPA-initiated proposal to establish exemptions from the
requirement of a tolerance for residues of the biochemical pesticides
sodium bicarbonate and potassium bicarbonate in or on all raw
agricultural commodities (RACs), when applied as fungicides or post-
harvest fungicides in accordance with good agricultural practices. EPA
is proposing this regulation on its own initiative pursuant to section
408(e)(1)(B) of FFDCA.
I. Background and Statutory Authority
The Food Quality Protection Act of 1996 (FQPA) (Pub. L. 104-170,
110 Stat. 1489) was signed into law August 3, 1996. FQPA amends both
the Federal Food, Drug and Cosmetic Act (FFDCA), 21 U.S.C. 301 et seq.,
and the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), 7
U.S.C. 136 et seq. The FQPA amendments went into effect immediately.
Among other things, FQPA amends FFDCA to bring all EPA pesticide
tolerance-setting activities under a new section 408 with a new safety
standard and new procedures.
New section 408(c)(2)(A)(i) allows EPA to establish an exemption
from the requirement of a tolerance only if EPA determines that the
exemption is ``safe.'' Section 408(c)(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, 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
an exemption 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...'' and specifies factors EPA is to
consider in establishing an exemption. Section 408(c)(3)(B) provides
for circumstances when no need exists for a practical method for
detecting and measuring levels of pesticide chemical residue in or on
food.
In light of FQPA, EPA is engaged in an intensive process, including
consultation with registrants, States, and other interested
stakeholders, to make decisions on the new policies and procedures that
will be appropriate as a result of enactment of FQPA. This process will
generally delay the review of food use applications, particularly those
involving exposure to children. EPA will publish a notice in the
Federal Register soon summarizing the requirements of FQPA, indicating
how EPA intends to meet those requirements, and describing actions
necessary to assure that EPA complies with the law. However, EPA also
intends to continue to issue tolerances and exemptions in the interim
pending publication of that notice. EPA also intends to issue interim
guidance to States and others on how EPA will implement section 408 in
the near future.
In deciding to issue tolerances and exemptions early in the process
of FQPA implementation, EPA recognizes that it will be necessary to
make decisions about the new FFDCA section 408, including the new
safety standard. In establishing tolerances and exemptions during this
interim period before EPA makes its broad policy decisions concerning
the interpretation and implementation of the new section 408, EPA does
not intend to set precedents for the application of section 408 and the
new safety standard to other tolerances and exemptions. Rather, these
early tolerance and exemption decisions will be made on a case-by-case
basis and will not bind EPA as it proceeds with further rulemaking and
policy development. EPA intends to act on tolerances and exemptions
that clearly qualify under the law.
[[Page 57358]]
II. Risk Assessment and Statutory Findings
Consistent with section 408(c)(2)(B), EPA has reviewed the
available scientific data and other relevant information in support of
this action. Sodium bicarbonate and potassium bicarbonate are already
registered by EPA as manufacturing use products for formulating into
fungicides for food and non-food plants. Sodium bicarbonate is exempted
from the requirement of a tolerance when used in accordance with good
agricultural practice as an inert (or occasionally active) ingredient
in pesticide formulations applied to growing crops or to raw
agricultural commodities after harvest (40 CFR 180.1001(c)). As a
minimal risk inert ingredient (List 4A) in pesticide products (59 FR
49400, September 28, 1994), sodium bicarbonate is recognized as safe
for use in pesticide products based upon its known properties. Sodium
bicarbonate is a permitted inert for formulating with the minimum risk
active ingredients exempted from regulation (61 FR 8876, March 6,
1996)(FRL-4984-8) under the Federal Insecticide, Fungicide and
Rodenticide Act (FIFRA). EPA has concluded that exemption of such
products will not pose unreasonable risks to public health or the
environment. The Food and Drug Administration (FDA) includes sodium
bicarbonate and potassium bicarbonate in its listing of substances
added directly to human food which have been found to be generally
recognized as safe. (21 CFR 184.1736 and 184.1613).
EPA has assessed the toxicology data base for sodium bicarbonate
and potassium bicarbonate and has sufficient data to assess the hazards
of both and to make a determination on aggregate exposure, consistent
with section 408(c)(2), for the exemptions from the requirement of a
tolerance. EPA's assessment of the exposures, including dietary
exposure, and risks associated with establishing these exemptions
follows.
A. Toxicological Profile
The data submitted in the Meiji Milk Products Co., Ltd. petition
and all other relevant material have been evaluated. The mammalian
toxicological data considered in support of the exemption from the
requirement of a tolerance for sodium bicarbonate include: an acute
oral toxicity study in rats, an acute dermal toxicity study in rabbits,
an acute inhalation data waiver request, a primary eye irritation study
in rabbits, a primary dermal irritation study in rabbits, and a dermal
sensitization study in guinea pigs.
The results of these studies indicated that sodium bicarbonate has
an acute oral LD50 greater than 5,000 mg/kg body weight in rats,
an acute dermal LD50 greater than 2,000 mg/kg body weight in
rabbits, causes minimal eye irritation and slight dermal irritation in
rabbits, and is a dermal non-sensitizer in guinea pigs (based on the
modified Beuhler Assay). The acute inhalation waiver request was
granted; data available to the Agency (from the earlier Church and
Dwight Co., Inc. submission) indicate that 100 percent sodium
bicarbonate has an LC50 greater than 4.74 mg/l in rats.
The acute mammalian toxicological data submitted by Church and
Dwight Co., Inc. indicated that sodium bicarbonate has an acute oral
LD50 greater than 5,000 mg/kg body weight in rats, an acute
inhalation LC50 greater than 4.74 mg/l in rats, and causes minimal
eye irritation and slight dermal irritation in rabbits. They further
indicate that potassium bicarbonate has an acute oral LD50 of
2,825 mg/kg body weight in rats, an acute dermal LD50 greater than
2,000 mg/kg body weight in rabbits, an acute inhalation LC50 of
4.96 mg/l in rats, causes slight eye irritation and slight skin
irritation in rabbits, and is a dermal non-sensitizer in guinea pigs.
B. Aggregate Exposure
For the purposes of assessing the potential dietary exposure under
this exemption, EPA considered that under this exemption sodium
bicarbonate and potassium bicarbonate could be present in all RACs.
Other potential sources of exposure of the general population to
residues of pesticides are residues in drinking water and exposure from
non-occupational sources. Based on the available studies used in EPA's
assessment of environmental risk, EPA does not anticipate exposure
residues of sodium bicarbonate or potassium bicarbonate in drinking
water. The potential for non-occupational, non-dietary exposure to the
general population is, thus, not expected to be significant.
EPA also considered the potential for cumulative effects of sodium
bicarbonate or potassium bicarbonate and other substances that have a
common mechanism of toxicity. EPA concluded that consideration of a
common mechanism of toxicity is not appropriate at this time. EPA has
not concluded that toxic effects produced by sodium bicarbonate or
potassium bicarbonate would be cumulative with those of any other
chemical compounds; thus EPA is considering only the potential risks of
sodium bicarbonate and potassium bicarbonate in its aggregate exposure
assessment.
C. Safety Determinations
1. U.S. population in general. Sodium bicarbonate and potassium
bicarbonate are naturally occurring substances which are required for
normal homeostatic mechanisms in humans, plants and the environment.
The Food and Drug Administration has listed both sodium and potassium
bicarbonate on its GRAS list (GRAS=generally recognized as safe). These
compounds are extensively used in pharmaceuticals, foods, and medical
devices and they have a wide distribution in commerce with no reported
adverse effects. The low toxicity of the subject active ingredients is
demonstrated by the data summarized above. Based on this information,
EPA has concluded that aggregate exposure to sodium bicarbonate or
potassium bicarbonate over a lifetime will not pose appreciable risks
to human health. EPA concludes that there is a reasonable certainty
that no harm will result from aggregate exposure to sodium bicarbonate
or potassium bicarbonate residues. Accordingly, EPA determines that
exempting sodium bicarbonate and potassium bicarbonate from the
requirement of a tolerance is safe.
2. Infants and children. EPA has determined that the toxicity and
exposure data are sufficiently complete to adequately address the
potential for additional sensitivity of infants and children to
residues of sodium bicarbonate or potassium bicarbonate. EPA concludes
that there is a reasonable certainty that no harm will result to
infants and children from aggregate exposure to sodium bicarbonate or
potassium bicarbonate residues.
D. Other Considerations
The Agency proposes to establish exemptions from the requirement of
a tolerance without any numerical limitation; therefore, the Agency has
concluded that analytical methods are not required for enforcement
purposes for either sodium bicarbonate or potassium bicarbonate.
E. Conclusion
Based on the information and data considered, EPA proposes that the
exemptions from the requirement of a tolerance be established as set
forth below.
III. Comments
Under FFDCA section 408(e)(2), EPA must provide for a public
comment period before issuing a final tolerance or tolerance exemption
under section
[[Page 57359]]
408(e)(1). The public comment period is to be for 60 days unless the
Administrator for good cause finds that it is in the public interest to
reduce that comment period. Based on several factors, EPA believes
there is good cause for reducing the comment period on these
exemptions. First, notice was already provided, in accordance with the
FFDCA prior to its recent amendment, for the exemption for sodium
bicarbonate. No comments were received in response to that notice.
Second, there is no question here regarding the safety of these
compounds. Sodium bicarbonate and potassium bicarbonate are substances
needed for normal homeostatic mechanisms and are now widely used in
pharmaceuticals and foods. Residues of these substances in foods from
their use as pesticides will be insignificant in comparison. Third, the
low toxicity of sodium bicarbonate and potassium bicarbonate represents
a safer alternative to traditional chemical fungicides currently
available to the public. In the FQPA, Congress urged EPA to give
priority to tolerance or exemption petitions for such safer pesticides.
See section 408 (d)(4)(B). Therefore, the Agency is allowing a 30 day
instead of a 60 day public comment period for these proposed tolerance
exemptions.
Interested persons are invited to submit written comments on the
proposed regulation. Comments must bear a notation indicating the
document control number, [OPP-300440]. All written comments filed in
response to this petition will be available in the Public Response and
Program Resources Branch at the address given above from 8 a.m. to 4:30
p.m. Monday through Friday, except legal holidays.
IV. Public Docket
A record has been established for this rulemaking under docket
number [OPP-300440] (including comments and data submitted
electronically as described below). 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 a.m. to 4:30 p.m. Monday through Friday, excluding legal
holidays. The public record is located in Room 1132 of the Public
Response and Program Resources Branch, Field Operations Division
(7506C), Office of Pesticide Programs, Environmental Protection Agency,
Crystal Mall #2, 1921 Jefferson Davis Highway, Arlington, VA 22202.
Electronic comments can be sent directly to EPA at:
opp-D[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 all comments received electronically into printed,
paper form as they are received and will place the paper copies in the
official rulemaking record which will also include all comments
submitted directly in writing. The official rulemaking record is the
paper record maintained at the address in ``ADDRESSES'' at the
beginning of this document.
V. Regulatory Assessment Requirements
Under Executive Order 12866 (58 FR 51735, October 4, 1993), this
action is not a ``significant regulatory action'' and, since this
action does not impose any information collection requirements as
defined by the Paperwork Reduction Act, 44 U.S.C. 3501 et seq., it is
not subject to review by the Office of Management and Budget. In
addition, this action does not impose any enforceable duty or contain
any unfunded mandate as described in the Unfunded Mandates Reform Act
of 1995 (Pub. L. 104-4), or require prior consultation with State
officials as specified by Executive Order 12875 (58 FR 58093, October
28, 1993), or special considerations as required by Executive Order
12898 (59 FR 7629, February 16, 1994).
Pursuant to the requirements of the Regulatory Flexibility Act
(Pub. L. 96-354, 94 Stat. 1164, 5 U.S.C. 601-612), the Administrator
has determined that regulations establishing new tolerances or raising
tolerance levels or establishing exemptions from tolerance requirements
do not have a significant economic impact on a substantial number of
small entities. A certification statement explaining the factual basis
for this determination was published in the Federal Register of May 4,
1981 (46 FR 24950).
Under 5 U.S.C. 801(a)(1)(A) of the Administrative Procedure Act
(APA) as amended by the Small Business Regulatory Enforcement Fairness
Act of 1996 (Title II of Pub. L. 104-121, 110 Stat. 847), EPA 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 in
today's Federal Register. This rule is not a ``major rule'' as defined
by 5 U.S.C. 804(2) of the APA as amended.
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 28, 1996.
Penelope A. Fenner-Crisp,
Acting Director, Office of Pesticide Programs.
Therefore, it is proposed that 40 CFR Chapter I be amended as
follows:
PART 180-- [AMENDED]
1. The authority citation for part 180 is revised to read as
follows:
Authority: 21 U.S.C. 346a and 371.
2. By adding new Secs. 180.1176 and 180.1177 to subpart D to read
as follows:
Sec. 180.1176 Sodium bicarbonate; exemption from the requirement of a
tolerance.
The biochemical pesticide sodium bicarbonate is exempted from the
requirement of a tolerance in or on all raw agricultural commodities
when applied as a fungicide or post-harvest fungicide in accordance
with good agricultural practices.
Sec. 180.1177 Potassium bicarbonate; exemption from the requirement
of a tolerance.
The biochemical pesticide potassium bicarbonate is exempted from
the requirement of a tolerance in or on all raw agricultural
commodities when applied as a fungicide or post-harvest fungicide in
accordance with good agricultural practices.
[FR Doc. 96-28421 Filed 11-5-96; 8:45 am]
BILLING CODE 6560-50-F