[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