North American Fruit Explorers mailing list at ibiblio

[Charles Paradise <machelp@attglobal.net>]

Can anyone add any information to this I found?
Are we talking outer bark?  Would it have to be composted to be 
effective or used as removed?
I happen to have cut down two tall alders this week.  I went out with a 
hatchet and removed some bark, everything down to the wood seems to come 
off with the bark.  So I'm guessing the corporation who applied is using 
bark from red alder in the northwest as that would likely be the only 
alder they could get useable amounts of bark from, anyway that's the 
only industry I know of using alder. 
Charlie Paradise

       Topic in gov.us.fed.epa.announce      

  
63FR53291 Alder Bark; Exemption from the Requirement of a Tolerance   
From:        roboposter - view profile
Date:        Mon, Oct 5 1998 12:00 am
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Archive-Name: gov/us/fed/nara/fed-register/1998/oct/05/63FR53291
Posting-number: Volume 63, Issue 192, Page 53291

[Federal Register: October 5, 1998 (Volume 63, Number 192)]
[Rules and Regulations]             
[Page 53291-53294]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr05oc98-11]

-----------------------------------------------------------------------

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[OPP-300728; FRL-6032-2]
RIN 2070-AB78

Alder Bark; Exemption from the Requirement of a Tolerance

AGENCY: Environmental Protection Agency (EPA).

-----------------------------------------------------------------------

ACTION: Final rule. SUMMARY: This regulation establishes an
exemption from the requirement of a tolerance for residues of
alder bark when used as an inert ingredient (seed germination
stimulator) in pesticide formulations applied to growing crops.
Platte Chemical Company requested this tolerance exemption under the 
Federal Food, Drug and Cosmetic Act (FFDCA), as amended by
the Food Quality Protection Act of 1996 (Pub. L. 104-170). DATES:
This regulation is effective October 5, 1998. Objections and
requests for hearings must be received by EPA on or before
November 4, 1998. ADDRESSES: Written objections and hearing
requests, identified by the docket control number, [OPP-300728],
must be submitted to: Hearing Clerk (1900), Environmental
Protection Agency, Rm. M3708, 401 M St., SW., Washington, DC
20460. Fees accompanying objections and hearing requests shall be
labeled ``Tolerance Petition Fees'' and forwarded to: EPA
Headquarters Accounting Operations Branch, OPP (Tolerance Fees),
P.O. Box 360277M, Pittsburgh, PA 15251. A copy of any objections
and hearing requests filed with the Hearing Clerk identified by
the docket control number, [OPP-300728], must also be submitted
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, bring a copy of objections and
hearing requests to Rm. 119, CM #2, 1921 Jefferson Davis Hwy.,
Arlington, VA. A copy of objections and hearing requests filed
with the Hearing Clerk may also be submitted electronically by
sending electronic mail (e-mail) to: opp-doc...@epamail.epa.gov.
Copies of objections and hearing requests must be submitted as an
ASCII file avoiding the use of special characters and any form of
encryption. Copies of objections and hearing requests will also
be accepted on disks in WordPerfect 5.1 file format or ASCII file
format. All copies of objections and hearing requests in
electronic form must be identified by the docket control number
[OPP-300728]. No Confidential Business Information (CBI) should
be submitted through e-mail. Electronic copies of objections and
hearing requests on this rule may be filed online at many Federal
Depository Libraries. FOR FURTHER INFORMATION CONTACT: By mail:
Indira Gairola, Registration Division 7505C, Office of Pesticide
Programs, Environmental Protection Agency, 401 M St., SW.,
Washington, DC 20460. Office location, telephone number, and
e-mail address: Rm. #707G, Crystal Mall #2, 1921 Crystal Drive,
Arlington, VA, 22202. Telephone No. (703)-308-8371, e- mail:
gairola.ind...@epamail.epa.gov. SUPPLEMENTARY INFORMATION: In the
Federal Register of April 29,1998 (63 FR 23438)(FRL-5783-4) EPA
issued a notice pursuant to section 408 of the FFDCA, 21 U.S.C.
346a announcing the filing of a pesticide petition (PP) 6E4742
for a tolerance exemption from Platte Chemical Company, 419 18th
Street, P.O. Box 667, Greeley, CO 80632, This notice included a
summary of the petition prepared by Platte Chemical Company, the
petitioner. There were no comments received in response to the
notice of filing. The petition requested that 40 CFR 180.1001(d)
be amended by establishing an exemption from the requirement of a
tolerance for residues of the inert ingredient alder bark when
used as an inert ingredient (seed germination stimulator) in
pesticide formulations applied to growing crops only.

I. Risk Assessment and Statutory Findings

New section 408(b)(2)(A)(i) of the FFDCA allows EPA to establish
a tolerance (the legal limit for a pesticide chemical residue in
or on a food) only if EPA determines that the tolerance is
``safe.'' Section 408(b)(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(b)(2)(C) requires EPA
to give special consideration to exposure of infants and children
to the pesticide chemical residue in establishing a tolerance and
to ``ensure that there is a reasonable certainty that no harm
will result to infants and children from aggregate

[[Page 53292]]

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 based primarily on toxicological studies
using laboratory animals. These studies address many adverse
health effects, including (but not limited to) reproductive
effects, developmental toxicity, toxicity to the nervous system,
and carcinogenicity. Second, EPA examines exposure to the
pesticide through the diet (e.g., food and drinking water) and
through exposures that occur as a result of pesticide use in
residential settings.

II. Inert Ingredient Definition

Inert ingredients are all ingredients that are not active
ingredients as defined in 40 CFR 153.125 and include, but are not
limited to, the following types of ingredients (except when they
have a pesticidal efficacy of their own): solvents such as
alcohols and hydrocarbons; surfactant such as polyoxyethylene
polymers and fatty acids; carriers such as clay and diatomaceous
earth; thickeners such as carrageenan and modified cellulose;
wetting, spreading, and dispersing agents; propellants in aerosol
dispensers; microencapsulating agents; and emulsifiers. The term
``inert'' is not intended to imply nontoxicity; the ingredient
may or may not be chemically active. Generally, EPA has exempted
inert ingredients from the requirement of a tolerance based on
the low toxicity of the individual inert ingredients.

III. Risk Assessment and Statutory Findings

EPA establishes exemptions from the requirement of a tolerance
only in those cases where it can be clearly demonstrated that the
risks from aggregate exposure to pesticide chemical residues
under reasonably foreseeable circumstances will pose no
appreciable risks to human health. In order to determine the
risks from aggregate exposure to pesticide inert ingredients, the
Agency considers the toxicity of the inert ingredient in
conjunction with possible exposure to residues of the inert
ingredient in food, drinking water, and other nonoccupational
exposures. If EPA is able to determine that a finite tolerance is
not necessary to ensure that there is a reasonable certainty that
no harm will result from aggregate exposure to the inert
ingredient, an exemption from the requirement of a tolerance may
be established.

IV. Aggregate Risk Assessment and Determination of Safety

Consistent with section 408(b)(2)(D), EPA has reviewed the
available scientific data and other relevant information in
support of this action, EPA has sufficient data to assess the
hazards of alder bark and to make a determination on aggregate
exposure, consistent with section 408(b)(2), an exemption from
the requirement of a tolerance for residues of alder bark when
used as an inert ingredient in pesticide formulations applied to
growing crops. EPA's assessment of the dietary exposures and
risks associated with establishing an exemption from the
requirement of a tolerance follows. The data submitted in the
petition and other relevant material have been evaluated. As part
of the EPA policy statement on inert ingredients published in the
Federal Register of April 22, 1987 (52 FR 13305) (FRL-3190-1),
the Agency set forth a list of studies which would generally be
used to evaluate the risks posed by the presence of an inert
ingredient in a pesticide formulation. However, where it can be
determined without that data that the inert ingredient will
present minimal or no risk, the Agency generally does not require
some or all of the listed studies to rule on the proposed
tolerance or exemption from the requirement of a tolerance for an
inert ingredient.

A. Toxicological Profile

Alder bark is the bark of an alder tree (Alnus glutinosa) that
has been dried and ground into a powder or flour form. The use of
alder bark as an inert ingredient in pesticide formulations is
not expected to result in adverse effects since it is primarily
comprised of lignin, hemicellulose and cellulose, each of which
has been extensively studied and been found not to exhibit any
adverse toxicological effects.

B. Exposures and Risks

1. From food and feed uses, drinking water, and non-dietary
exposures. For the purposes of assessing the potential dietary
exposure, EPA considered that under this tolerance exemption
alder bark could be present in all raw and processed agricultural
commodities and drinking water and that non-occupational,
non-dietary exposure was possible. However, based on the use of
alder bark as a seed germination stimulator, it is likely that
residues of alder bark would not be present in or on food or
drinking water. EPA therefore concludes that, based on the lack
of expected adverse effects and the lack of expected residues of
alder bark in or on raw agricultural commodities or drinking
water, there are no concerns for risks associated with any
exposure scenarios that are reasonably foreseeable. 2. Cumulative
exposure to substances with common mechanism of toxicity. Section
408(b)(2)(D)(v) requires that, when considering whether to
establish, modify, or revoke a tolerance, the Agency consider
``available information'' concerning the cumulative effects of a
particular pesticide's residues and ``other substances that have
a common mechanism of toxicity.''Because EPA has concluded that
alder bark is basically non-toxic, EPA has not assumed that alder
bark has a common mechanism of toxicity with other substances.

C. Aggregate Risks and Determination of Safety for U.S.
Population

Based on the lack of expected adverse effects resulting from the
use of alder bark, EPA concludes that there is a reasonable
certainty that no harm to the U.S. population will result from
aggregate exposure to alder bark. EPA believes this compound
presents no dietary risk under reasonably foreseeable
circumstances.

D. Aggregate Risks and Determination of Safety for Infants and
Children

FFDCA section 408 provides that EPA shall apply an additional
tenfold margin of safety for infants and children in the case of
threshold effects to account for pre-and postnatal toxicity and
the completeness of the database unless EPA determines that a
different margin of safety will be safe for infants and children.
Margins of safety are incorporated into EPA risk assessments
either directly through use of a MOE analysis or through using
uncertainty (safety) factors in calculating a dose level that
poses no appreciable risk to humans. In this instance, the Agency
believes that there are reliable data to support that fact that
alder bark would be expected to be practically nontoxic to
humans, and thus EPA has not used a safety factor analysis in
assessing the risk of this compound. For the same reasons the
additional safety factor is unnecessary.

E. International Residue Limits

No Codex maximum residue levels have been established for alder
bark.

V. Conclusion

Therefore, an exemption from the requirement of a tolerance is
established for residues of alder bark when used as

[[Page 53293]]

an inert ingredient in pesticide formulations applied to growing
crops.

VI. Objections and Hearing Requests

The new FFDCA section 408(g) provides essentially the same
process for persons to ``object'' to a tolerance regulation
issued by EPA under new section 408(e) and (l)(6) as was provided
in the old section 408 and in section 409. However, the period
for filing objections is 60 days, rather than 30 days. EPA
currently has procedural regulations which govern the submission
of objections and hearing requests. These regulations will
require some modification to reflect the new law. However, until
those modifications can be made, EPA will continue to use those
procedural regulations with appropriate adjustments to reflect
the new law. Any person may, by December 4, 1998, file written
objections to any aspect of this 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 issues on which a hearing is requested, the
requestor's contentions on such issues, and a summary of any
evidence relied upon by the requestor (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 genuine
and substantial issue of fact; there is a 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 issues in the manner
sought by the requestor would be adequate to justify the action
requested (40 CFR 178.32). Information submitted in connection
with an objection or hearing request 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 information that does not contain CBI
must be submitted for inclusion in the public record. Information
not marked confidential may be disclosed publicly by EPA without
prior notice.

VII. Public Record and Electronic Submissions

EPA has established a record for this rulemaking under docket
control number [OPP-300728] (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 8:30 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. Electronic
comments can be sent directly to EPA at:
opp-doc...@epamail.epa.gov

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 Virginia address in
``ADDRESSES'' at the beginning of this document.

VIII. Regulatory Assessment Requirements

A. Certain Acts and Executive Orders

This final rule establishes an exemption from the requirement of
a tolerance under FFDCA section 408(d) in response to a petition
submitted to the Agency. 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 final rule 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 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). In addition, since these
tolerances and exemptions that are established on the basis of a
petition under FFDCA section 408(d), such as the tolerance
exemption in this final rule, do not require the issuance of a
proposed rule, the requirements of the Regulatory Flexibility Act
(RFA) (5 U.S.C. 601 et seq.) do not apply. Nevertheless, the
Agency has 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.

B. Executive Order 12875

Under Executive Order 12875, entitled Enhancing Intergovernmental
Partnerships (58 FR 58093, October 28, 1993), EPA may not issue a
regulation that is not required by statute and that creates a
mandate upon a State, local or tribal government, unless the
Federal government provides the funds necessary to pay the direct
compliance costs incurred by those governments. If the mandate is
unfunded, EPA must provide to the Office of Management and Budget
(OMB) a description of the extent of EPA's prior consultation
with representatives of affected State, local and tribal
governments, the nature of their concerns, copies of any written
communications from the governments, and a statement supporting
the need to issue the regulation. In addition, Executive Order
12875 requires EPA to develop an effective process permitting
elected officials and other representatives of State, local and
tribal governments ``to provide meaningful and timely input in
the development of regulatory proposals containing significant
unfunded mandates.'' Today's rule does not create an unfunded
federal mandate on State, local or tribal governments. The rule
does not impose any enforceable duties on these entities.
Accordingly, the requirements of section 1(a) of

[[Page 53294]]

Executive Order 12875 do not apply to this rule.

C. Executive Order 13084

Under Executive Order 13084, entitled Consultation and
Coordination with Indian Tribal Governments (63 FR 27655, May
19,1998), EPA may not issue a regulation that is not required by
statute, that significantly or uniquely affects the communities
of Indian tribal governments, and that imposes substantial direct
compliance costs on those communities, unless the Federal
government provides the funds necessary to pay the direct
compliance costs incurred by the tribal governments. If the
mandate is unfunded, EPA must provide OMB, in a separately
identified section of the preamble to the rule, a description of
the extent of EPA's prior consultation with representatives of
affected tribal governments, a summary of the nature of their
concerns, and a statement supporting the need to issue the
regulation. In addition, Executive Order 13084 requires EPA to
develop an effective process permitting elected and other
representatives of Indian tribal governments ``to provide
meaningful and timely input in the development of regulatory
policies on matters that significantly or uniquely affect their
communities.'' Today's rule does not significantly or uniquely
affect the communities of Indian tribal governments. This action
does not involve or impose any requirements that affect Indian
Tribes. Accordingly, the requirements of section 3(b) of
Executive Order 13084 do not apply to this rule.

IX. Submission to Congress and the Comptroller General

The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the 
Small Business Regulatory Enforcement Fairness Act of 1996, generally 
provides that before a rule may take effect, the Agency promulgating the 
rule must submit a rule report, which includes a copy of the rule, to 
each House of the Congress and the Comptroller General of the United 
States. EPA will submit 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 United States prior to publication of the 
rule in the Federal Register. This rule is not a ``major rule'' as 
defined by 5 U.S.C. 804(2).

List of Subjects in 40 CFR Part 180

   Environmental protection, Administrative practice and procedure,
Agricultural commodities, Pesticides and pests, Reporting and
recordkeeping requirements.

   Dated: September 24, 1998.

Arnold E. Layne,

Acting Director, Registration Division, Office of Pesticide Programs.
   Therefore, 40 CFR chapter I 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 Sec. 180.1001 the table in paragraph (d) is amended by adding
alphabetically the following inert ingredient to read as follows:

Sec. 180.1001  Exemptions from the requirement of a tolerance.

*        *        *        *        *
   (d) *    *    *

------------------------------------------------------------------------
     Inert ingredients                 Limits                Uses
------------------------------------------------------------------------
        *        *        *        *        *        *        *
Alder bark...................                           Seed germination
                                                        stimulator
        *        *        *        *        *        *        *
------------------------------------------------------------------------

[FR Doc. 98-26618 Filed 10-2-98; 8:45 am]
BILLING CODE 6560-50-F