[Federal Register Volume 61, Number 60 (Wednesday, March 27, 1996)]
[Rules and Regulations]
[Pages 13424-13426]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-7444]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[PP 5F4509/R2221; FRL-5357-9]
Meat Meal and Red Pepper; 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 the active ingredients meat meal and red
pepper in or on all raw agricultural commodities when applied as animal
repellants in accordance with good agricultural practices. This
exemption was requested by Lakeshore Enterprises.
EFFECTIVE DATE: The regulation becomes effective on March 27, 1996.
ADDRESSES: Written objections and hearing requests, identified by the
docket number, [PP 5F4509/R2221], may be submitted to: Hearing Clerk
(1900), Environmental Protection Agency, Rm. M3708, 401 M St., SW.,
Washington, DC 20460. A copy of any objections and hearing requests
filed with the Hearing Clerk should be identified by the docket number
and submitted to: Public Response and Program Resources Branch, Field
Operations Division (7506C), Office of Pesticide Programs,
Environmental
[[Page 13425]]
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 22202. Fees accompanying
objections shall be labeled ``Tolerance Petition Fees'' and forwarded:
EPA Headquarters Accounting Operations Branch, OPP (Tolerance Fees),
P.O. Box 360277M, Pittsburgh, PA 15251. An electronic copy of
objections and hearing requests filed with the Hearing Clerk may be
submitted to OPP by sending electronic mail (e-mai l) to: docket@epamail.epa.gov
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 file format
or ASCII file format. All copies of electronic objections and hearing
requests must be identified by the docket number [PP 5F4509/R2221] . 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. Additional
information on electronic submissions can be found below in this
document.
FOR FURTHER INFORMATION CONTACT: By mail: Julie Fry, Biopesticides and
Pollution Prevention Division, Office of Pesticide Programs (7501W), U.
S. Environmental Protection Agency, 401 M St., SW., Washington, DC
20460. Office location and telephone number: 5th Floor CS1, 2800
Crystal Drive, Arlington, VA 22202, Telephone 703-308-8673, e-mail:
fry.julie@epamail.epa.gov.
SUPPLEMENTARY INFORMATION: In the Federal Register of February 7, 1996,
EPA issued a notice that Lakeshore Enterprises had submitted pesticide
petition 5F4509 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 biochemicals meat meal
and red pepper (synonyms include capsicum, cayenne pepper, chile
pepper) in or on all raw agricultural commodities when applied as
animal repellants in accordance with good agricultural practices. The
Agency received one comment opposing tolerance levels proposed for the
pesticides described primarily based on possible roles of pesticides in
neurotoxicity. The commentor also supported the promotion of ``safe/
safer'' alternatives to toxic chemicals. The Agency believes that the
subject active ingredients, meat meal and red pepper, don't pose a risk
including risk of neurotoxicity based on their extended use without any
reported adverse effects. Furthermore, both meat meal and red pepper
fall in the category of ``safe/safer'' pesticides, as supported by the
response of the commentor.
Product Chemistry
Meat Meal
Meat meal is a sterilized, animal food by-product produced at
livestock rendering plants from clean, fresh animal proteins. It is
composed of greater than or equal to 85% crude protein, greater than or
equal to 8% crude fiber, less than or equal to 3% fat, and less than or
equal to water. This composition may vary from the batch-to-batch,
depending on the by-products rendered (traces of hair, stomach
belchings and urine might occur unavoidably in good manufacturing
processes.) The moisture is removed from the crude product and the
dried meat meal is sterilized at a temperature ranging from 210 deg.F
to 250 deg.F for at least 1 1/2 hours. No chemicals are added to the
meat meal. The resulting product is an unconsolidated fibrous powder.
Red Pepper
Red pepper is natural, processed vegetable matter that has been
part of the human diet for many years. Red pepper is made by
dehydrating fresh red chili pepper pods (Capsicum spp.), processing the
dried pods through a mill and sifter, then blending the varieties of
pepper powder into a final product. Known constituents of red pepper
include capsaicin oil (0.1 - 1%), the source of red pepper's pungent
effect and capsanthin, a carotenoid pigment.
Human Health Risk Assessment
EPA waived the data requirements for residue chemistry and
toxicology data pursuant to 40 CFR 177.110(b) because it was
unnecessary. As discussed below, EPA already has adequate information
to determine that meat meal and red pepper do not pose a human health
hazard without the waived data.
Meat Meal
Meat meal is available from livestock rendering plants nationwide;
it is widely distributed in commerce and available to the general
public. It is used as an animal food/feed supplement and as organic
fertilizer. No significant adverse effects from exposure to meat meal
have been reported. The expected uses of meat as an olfactory animal
repellant will include meat meal packaged in bags and applied in powder
form around the base of plants. Meat meal will not be applied directly
to the plant. Negligible human exposure is anticipated.
Meat meal is composed mainly of sterilized animal proteins and
fats. These natural components do not persist in the environment
because they biodegrade rapidly. Furthermore, meat meal has been
identified by EPA as a List 4A-Minimum Risk Inert. This list, published
in the Federal Register, September 28, 1994 (59 FR 49400), identifies
substances ``considered to be of minimal risk in pesticide products to
human health when used as inert ingredients.'' These substances are
also exempt from the requirement of tolerance when used as an inert
ingredient. EPA believes that the risk from the use of meat meal on
food is comparable whether it is used as an active or as an inert
ingredient.
Red Pepper
Lack of toxicity of red pepper is supported by its long history of
use by humans as a food additive/component without any indication of
deleterious effects. Red peppers are ubiquitous in the cooking of many
African countries and most of India, Ceylon and S.E. Asia. (Capsicum
spp). Pepper exports amount to 176,000 tons annually (Ref. 1) (Rehm, S.
and G. Espig. 1991. The Cultivated Plants of the Tropics and Subtropics
- Cultivation, Economic Value, Utilization. Verlag Josef Margraf
Scientific Books. Berlin, Germany. Pages 279-280). Red pepper is listed
by the Food and Drug Administration as Generally Regarded as Safe
(GRAS) in 21 CFR part 182. Furthermore, red pepper, a common food
additive/component, also falls within the scope of the policy announced
in the Federal Register, September 28, 1994 (59 FR 49400) which states
``... EPA is announcing that substances commonly consumed as food will
also be considered minimal risk, List 4A, even if they have previously
not been used in pesticide products and are therefore not currently on
the list. Substances commonly consumed as foods will be considered
acceptable for use in all pesticide products, both food and nonfood
use, and will not require a specific exemption from tolerance.'' EPA
believes the risk from the use of red pepper on food is comparable
whether it is used as an active or as an inert ingredient.
Conclusion
Based on the low toxicity of meat meal, a sterilized food by-
product and
[[Page 13426]]
red pepper, a common additive/component of the human diet, the Agency
concludes that establishment of a tolerance is not necessary to protect
the public health. Therefore, the exemption from tolerance is
established as set forth below.
Any person adversely affected by this regulation may, within 30
days after publication of this document in the Federal Register, 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
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 a 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).
EPA has established a record for this rulemaking under docket
number [PP 5F4509/R2221] (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 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.
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 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
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.
References Cited
The following reference is cited in this tolerance rule:
(1) Rehm, S. and G. Espig. (1991). The Cultivated Plants of the
Tropics and Subtropics - Cultivation, Economic Value, Utilization.
Verlag Josef Margraf Scientific Books. Berlin, Germany. pp. 279-280.
Under Executive Order 12866 (58 FR 51735, October 4, 1993), the
Agency must determine whether the regulatory action is ``significant''
and therefore subject to all the requirements of the Executive Order
(i.e., Regulatory Impact Analysis, review by the Office of Management
and Budget (OMB)). Under section 3(f), the order defines
``significant'' as those actions likely to lead to a rule (1) having an
annual effect on the economy of $100 million or more, or adversely and
materially affecting a sector of the economy, productivity,
competition, jobs, the environment, public health or safety, or State,
local or tribal governments or communities (also known as
``economically significant''); (2) creating serious inconsistency or
otherwise interfering with an action taken or planned by another
agency; (3) materially altering the budgetary impacts of entitlements,
grants, user fees, or loan programs; or (4) raising novel legal or
policy issues arising out of legal mandates, the President's
priorities, or the principles set forth in this Executive Order.
Pursuant to the terms of this Executive Order, EPA has determined
that this rule is not ``significant'' and is therefore not subject to
OMB review.
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 to this effect was published
in the Federal Register of May 4, 1981 (46 FR 24950).
Pursuant to Title II of the Unfunded Mandates Reform Act of 1995,
Pub. L. 104-4, EPA has determined that this regulation does not impose
a Federal mandate upon State, local, or tribal governments or the
private sector and does not contain any regulatory requirements that
might significantly or uniquely affect small governments because the
regulation does not impose any enforceable duties upon those entities.
List of Subjects in 40 CFR Part 180
Environmental protection, Administrative practice and procedure,
Agricultural commodities, Pesticides and pests, Reporting and
recordkeeping requirements.
Dated: March 18, 1996.
Daniel M. Barolo,
Director, Office of Pesticide Programs.
Therefore, 40 CFR part 180 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. In subpart D, by adding Sec. 180.1164, to read as follows:
Sec. 180.1164 Food and food by-products; exemption from the
requirement of a tolerance.
(a) Meat meal, a sterilized food by-product, is exempt from the
requirement of a tolerance on all raw agricultural commodities when
used as an olfactory animal repellent.
(b) Red pepper (Capsicum spp.) is exempt from the requirement of a
tolerance on all raw agricultural commodities when used as a gustatory
animal repellent.
[FR Doc. 96-7444 Filed 3-26-96; 8:45 am]
BILLING CODE 6560-50-F
