[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: opp-
[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 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: 
[email protected].
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:

    [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 
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]
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