[Federal Register Volume 63, Number 132 (Friday, July 10, 1998)]
[Proposed Rules]
[Pages 37307-37309]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-18280]
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ENVIRONMENTAL PROTECTION AGENCY
[OPP-300680; FRL-6016-1]
40 CFR Part 180
RIN 2070-AB18
Food and Food By-Products Used as a Pesticide; Proposed Exemption
From the Requirement of a Tolerance
AGENCY: Environmental Protection Agency (EPA).
ACTION: Proposed rule.
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SUMMARY: EPA proposes to establish an exemption from the requirement of
a tolerance for residues of any edible food commodity (except for
peanuts, tree nuts, milk, soybean, eggs, fish, crustacea, and wheat)
used as a pesticide, when applied in accordance with good agricultural
practices, in or on all food commodities. Any edible food commodity
used as a pesticide under this exemption must not be ``adulterated
food'' as defined in FFDCA section 402. 21 U.S.C. 342. The exemption
from the requirement of a tolerance is being proposed by the Agency on
its own initiative, since the
[[Page 37308]]
Agency believes that the exemption for edible food commodities will be
safe.
DATES: Comments, identified by the docket control number [OPP-300680],
must be received on or before September 8, 1998.
ADDRESSES: By mail, submit written comments to: Public Information and
Records Integrity Branch, Information Resources and Services Division
(7502C), Office of Pesticide Programs, Environmental Protection Agency,
401 M St., SW., Washington, DC 20460. In person, deliver comments to:
Rm. 119, CM #2, 1921 Jefferson Davis Highway, Arlington, VA 22202.
Information 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. 119
at the address given above, from 8:30 a.m. to 4 p.m., Monday through
Friday, excluding legal holidays.
Comments and data may also be submitted electronically by following
the instructions under Unit IV of this document. No Confidential
Business Information (CBI) should be submitted through e-mail.
FOR FURTHER INFORMATION CONTACT: By mail: Freshteh Toghrol,
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: Crystal Station #1, 5th Floor, 2805 Crystal Drive, Arlington,
VA 22202; (703) 308-7014; toghrol.freshteh@epamail.epa.gov.
SUPPLEMENTARY INFORMATION: Pursuant to section 408(e) of the Federal
Food, Drug and Cosmetic Act (FFDCA), 21 U.S.C. 346a(e), EPA proposes to
amend 40 CFR part 180 by establishing an exemption from the requirement
of a tolerance for residues of any edible food commodity (except for
peanuts, tree nuts, milk, eggs, fish, crustacea, and wheat) used as a
pesticide, when applied in accordance with good agricultural practices
in or on all food commodities. By edible food commodity, EPA means
foods that are widely consumed for their nutrient properties. This
exemption would not apply to any ``adulterated food'' under FFDCA
section 402.
I. Statutory Authority
New section 408(c)(2)(A)(i) 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
exemption from tolerance 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 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 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....'' 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.
II. Risk Assessment and Statutory Findings
Under the conditions of the proposed tolerance exemption for
residues of any edible food commodity used as a pesticide (as defined
above) in or on all food commodities, and in consideration of the
conditions, criteria, and requirements set forth by FQPA, the Agency
believes that this tolerance exemption will be safe for humans,
including infants and children. This exemption only applies to those
foods that have been widely consumed for their nutrient properties. Any
safety concerns regarding exposure to residues of such edible food
commodities have been addressed by the long history of safe use of
these foods in commerce, as well as the adequate regulation of foods by
the Food and Drug Administration. Additionally, any cumulative effects
from aggregate exposure to residues of food commodities when used as
pesticides in or on other food commodities would not likely impact
those effects that may occur from much broader exposure via consumption
of food in the diet.
Some edible foods produce an allergic reaction in certain
individuals. Allergy to food proteins occurs in less than 1 to 2% of
the population. The majority of individuals with documented immunologic
reactions to foods exhibit immunoglobulin E (IgE)-mediated immediate
hypersensitivity reactions that can be sudden and severe. Current
scientific knowledge suggest that common food allergens are
glycosylated proteins, which tends to be resistant to degradation by
heat, acid, and proteases. Where food allergy is confirmed patients are
usually allergic to only a few specific proteins within one or two
specific foods. Eight food or food groups (peanut, soybean, tree nuts,
milk, eggs, fish, crustacea, and wheat) account for the vast majority
of documented food allergies worldwide (the Food and Agriculture
Organization (FAO) of the United Nation: Report of the FAO Technical
Consultation on Food Allergies, Rome, Italy, November 13-14, 1995).
Even though, as explained below, there are unlikely to be significant
residues from use of edible food as a pesticide, the Agency has decided
not to include those known allergenic food commodities in this
exemption.
The Agency believes that food commodities will be used as
pesticides to control or mitigate pests or as plant growth regulators
in only very limited cases. It is unlikely that an edible food
commodity could be used to control a pest via a toxic mode of action.
This assumption is supported by the Agency's experience to date where
food commodities have been used to attract, repel or otherwise suppress
pests. The purported mechanisms of action for food commodities involve
feeding deterrence for herbivorous insects or mammals or an alteration
in the microbial flora which suppresses the microbial pests. In the
case of an altered microbial populations, it is necessary for the food
commodity to be degraded or metabolized before the desired effect can
occur.
The Agency also believes that residues from any edible food
commodity, when used as a pesticide on another food commodity would be
minimal to non-existent because of rapid degradation in the
environment.
No tolerances or exemptions from requirements of tolerances have
been issued in the United States or internationally for all food
commodities as biochemical pesticides; however, some individual foods
or food by-products have tolerance exemptions in the United States.
III. Safety Determination for U.S. Population and Infants and
Children
The Agency believes that this tolerance exemption will be safe for
humans, including infants and children.
[[Page 37309]]
Any safety concerns regarding exposure to residues of edible food
commodities have been addressed by the long history of safe use of
foods in commerce, as well as the adequate regulation of foods by the
Food and Drug Administration. Additionally, any cumulative effects from
aggregate exposure to residues of food commodities when used as
pesticides in or on other food commodities would not likely impact
those effects that may occur from much broader exposure via consumption
of food in the diet. Since food commodities are non toxic to humans
including infants and children, EPA has not assessed the risk from food
commodities using a safety factor approach. Accordingly, application of
an additional 10X safety factor analysis or quantitative risk
assessment for the protection of infants and children is not necessary
to protect the safety of infants and children.
Consistent with section 408(b)(2)(D), EPA has reviewed the
available scientific data and other relevant information in support of
this action. Based on the information and data considered, the Agency
has determined that, in amending 40 CFR 180.1164, as proposed, there is
reasonable certainty that no harm to the general population, including
infants and children will result from aggregate exposure to edible food
commodities used as pesticides. An exemption from tolerance is
appropriate for these pesticides because EPA believes they do not pose
a dietary risk under reasonably forseeable circumstances. Accordingly,
EPA proposes that the exemption from the requirement of a tolerance be
established as set forth below.
IV. Public Docket and Electronic Submissions
The official record for this rule making, as well as the public
version, has been established for this rule making under document
control number [OPP-300680] (including 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 119 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. 22202.
Electronic comments may be sent directly to EPA at:
opp-docket@epamail.epa.gov
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 rule making, as well as the public
version, as described above will be kept in paper form. Accordingly,
EPA will transfer any copies of comments received electronically into
printed paper form as they are received and will place the paper copies
in the official rule making record. The official rule making record is
the paper record maintained at the Virginia address in ``ADDRESSES'' at
the beginning of this document.
V. Regulatory Assessment Requirements
This rule proposes an exemption from the requirement of a tolerance
under FFDCA section 408(d). The EPA is proposing this regulation on its
own initiative. 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 action 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, 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).
Pursuant to the requirements of the Regulatory Flexibility Act
(Pub. L. 96-354, 94 Stat. 1164, 5 U.S.C. 601-612), 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.
List of Subjects in 40 CFR Part 180
Environmental protection, Agricultural commodities, Food additives,
Feed additives, Pesticides and pests, Reporting and record keeping
requirements.
Dated: June 29, 1998.
Kathleen D. Knox,
Acting Director, Biopesticides and Pollution Prevention Division,
Office of Pesticide Programs.
Therefore, 40 CFR chapter I, part 180 is proposed to be 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 180.1164 is amended by adding paragraph (d) to read as
follows:
Sec. 180.1164 Food and food by-products; exemption from the
requirement of a tolerance.
* * * * *
(d) Any edible food commodity (except for peanuts, tree nuts, milk,
eggs, fish, crustacea, and wheat) used as a pesticide is exempted from
the requirement of a tolerance when used in accordance with good
agricultural practice in or on all food commodities. This exemption
shall not apply to any edible food commodity that is adulterated under
section 342 of Title 21 of the United States Code.
[FR Doc. 98-18280 Filed 7-9-98; 8:45 am]
BILLING CODE 6560-50-F
