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Clopyralid - Pesticide Tolerance for Emergency Exemption 3/97

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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[OPP-300458; FRL-5593-1] RIN 2070-AB78
Clopyralid; Pesticide Tolerance for Emergency Exemption
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
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SUMMARY: This regulation establishes a time-limited tolerance for residues of
the herbicide clopyralid in or on the raw agricultural commodity cranberries
in connection with EPA's granting of emergency exemptions under section 18 of
the Federal Insecticide, Fungicide, and Rodenticide Act authorizing use of
clopyralid on cranberries in the states of Massachusetts, Oregon, and
Washington. This regulation establishes maximum permissible levels for
residues of clopyralid in this food. The tolerance will expire July 31, 1998.
DATES: This regulation becomes effective March 12, 1997. This regulation
expire on July 31, 1998. Objections and requests for hearings must be received
by EPA on or before May 12, 1997.
ADDRESSES: Written objections and hearing requests, identified by the docket
control number, [OPP-300458], 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-300458], must also be submitted 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, bring a copy of objections and hearing requests to Rm. 1132,
CM #2, 1921 Jefferson Davis Highway, 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-
docket@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-300458]. 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: Libby Pemberton, Registration
Division (7505W), Office of Pesticide Programs, Environmental Protection
Agency, 401 M St., SW., Washington, DC 20460. Office location, telephone
number, and e-mail: Sixth Floor, Crystal Station #1, 2800 Jefferson Davis
Highway, Arlington, VA 22202. (703) 308-8326, e-mail:
pemberton.libby@epamail.epa.gov.

SUPPLEMENTARY INFORMATION: EPA, on its own
initiative, pursuant to section 408(e) and (l)(6) of the Federal Food, Drug,
and Cosmetic Act (FFDCA), 21 U.S.C. 346a(e) and (l)(6), is establishing a
tolerance for residues of clopyralid on cranberries at 2 parts per million
(ppm). This tolerance will expire on July 31, 1998.
I. Background and Statutory Authority
The Food Quality Protection Act of 1996 (FQPA) (Pub. L. 104-170) was signed
into law August 3, 1996. FQPA amends both the 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. These activities are described below and discussed in greater
detail in the final rule establishing the time-limited tolerance associated
with the emergency exemption for use of propiconazole on sorghum (61 CFR
58135, November 13, 1996)(FRL-5572-9).
New section 408(b)(2)(A)(i) 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, 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
exposure to the pesticide chemical residue...."
Section 18 of FIFRA authorizes EPA to exempt any Federal or State agency from
any provision of FIFRA, if EPA determines that "emergency conditions exist
which require such exemption." This provision was not amended by FQPA. EPA has
established regulations governing such emergency exemptions in 40 CFR part
166.
Section 408(l)(6) requires EPA to establish a time-limited tolerance or
exemption from the requirement for a tolerance for pesticide chemical residues
in food that will result from the use of a pesticide under an emergency
exemption granted by EPA under section 18 of FIFRA. Section 408(l)(6) also
requires EPA to promulgate regulations by August 3, 1997, governing the
establishment of tolerances and exemptions under section 408(l)(6) and
requires that the regulations be consistent with section 408(b)(2) and (c)(2)
and FIFRA section 18. Section 408(l)(6) allows EPA to establish tolerances or
exemptions from the requirement for a tolerance, in connection with EPA's
granting of FIFRA section 18 emergency exemptions, without providing notice or
a period for public comment. Thus, consistent with the need to act
expeditiously on requests for emergency exemptions under FIFRA, EPA can
establish such tolerances or exemptions under the authority of section 408(e)
and (l)(6) without notice and comment rulemaking.
In establishing section 18-related tolerances and exemptions during this
interim period before EPA issues the section 408(l)(6) procedural regulation
and 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 section 18 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 section 18- related tolerances and exemptions that clearly qualify
under the new law.
II. Emergency Exemptions for Clopyralid on Cranberries and FFDCA Tolerances
EPA has authorized use under FIFRA section 18 of clopyralid on cranberries for
control of various weeds. Cancellations of the most effective registered
alternatives have left growers with few tools to control weeds in a crop which
cannot be cultivated. Over time, since control has been less than adequate,
the problems have gotten steadily worse, resulting in near-epidemic levels of
herbaceous perennial weeds over the past few years on many cranberry farms.
The projected yield loss on the affected acres would cause those growers to
suffer a significant economic loss.
As part of its assessment of these specific exemptions, EPA assessed the
potential risks presented by residues of clopyralid on cranberries. In doing
so, EPA considered the new safety standard in FFDCA section 408(b)(2), and EPA
decided that the necessary tolerance under FFDCA section 408(l)(6) would
clearly be consistent with the new safety standard and with FIFRA section 18.
This tolerance for residues of clopyralid will permit the marketing of
cranberries treated in accordance with the provisions of the section 18
emergency exemptions. Consistent with the need to move quickly on these
emergency exemptions in order to address an urgent non-routine situation and
to ensure that the resulting food is safe and lawful, EPA is issuing this
tolerance without notice and opportunity for public comment under section
408(e) as provided in section 408(l)(6). Although this tolerance will expire
on July 31, 1998, under FFDCA section 408(l)(5), residues of clopyralid not in
excess of the amount specified in this tolerance remaining in or on
cranberries after that date will not be unlawful, provided the pesticide is
applied during the term of, and in accordance with all the conditions of, the
emergency exemptions. EPA will take action to revoke this tolerance earlier if
any experience with, scientific data on, or other relevant information on this
pesticide indicate that the residues are not safe.
EPA has not made any decisions about whether clopyralid meets the requirements
for registration under FIFRA section 3 for use on cranberries or whether a
permanent tolerance for clopyralid for cranberries would be appropriate. This
action by EPA does not serve as a basis for registration of clopyralid by a
State for special local needs under FIFRA section 24(c). Nor does this action
serve as the basis for any States other than Massachusetts, Oregon, and
Washington to use this product on this crop under section 18 of FIFRA without
following all provisions of section 18 as identified in 40 CFR part 166. For
additional information regarding the emergency exemptions for clopyralid,
contact the Agency's Registration Division at the address provided above.
III. Risk Assessment and Statutory Findings
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. For many of these studies, a dose response
relationship can be determined, which provides a dose that causes adverse
effects (threshold effects) and doses causing no observed effects (the "no-
observed effect level" or "NOEL").
Once a study has been evaluated and the observed effects have been determined
to be threshold effects, EPA generally divides the NOEL from the study with
the lowest NOEL by an uncertainty factor (usually 100 or more) to determine
the Reference Dose (RfD). The RfD is a level at or below which daily aggregate
exposure over a lifetime will not pose appreciable risks to human health. An
uncertainty factor (sometimes called a "safety factor") of 100 is commonly
used since it is assumed that people may be up to 10 times more sensitive to
pesticides than the test animals, and that one person or subgroup of the
population (such as infants and children) could be up to 10 times more
sensitive to a pesticide than another. In addition, EPA assesses the potential
risks to infants and children based on the weight of the evidence of the
toxicology studies and determines whether an additional uncertainty factor is
warranted. Thus, an aggregate daily exposure to a pesticide residue at or
below the RfD (expressed as 100 percent or less of the RfD) is generally
considered acceptable by EPA.
Lifetime feeding studies in two species of laboratory animals are conducted to
screen pesticides for cancer effects. When evidence of increased cancer is
noted in these studies, the Agency conducts a weight of the evidence review of
all relevant toxicological data including short term and mutagenicity studies
and structure activity relationship. Once a pesticide has been classified as a
potential human carcinogen, different types of risk assessments (e.g., linear
low dose extrapolations or margin of exposure calculation based on the
appropriate NOEL) will be carried out based on the nature of the carcinogenic
response and the Agency's knowledge of its mode of action.
In examining aggregate exposure, FFDCA section 408 requires that EPA take into
account available and reliable information concerning exposure from the
pesticide residue in the food in question, residues in other foods for which
there are tolerances, and other non- occupational exposures, such as where
residues leach into groundwater or surface water that is consumed as drinking
water. Dietary exposure to residues of a pesticide in a food commodity are
estimated by multiplying the average daily consumption of the food forms of
that commodity by the tolerance level or the anticipated pesticide residue
level. The Theoretical Maximum Residue Contribution (TMRC) is an estimate of
the level of residues consumed daily if each food item contained pesticide
residues equal to the tolerance. The TMRC is a "worst case" estimate since it
is based on the assumptions that food contains pesticide residues at the
tolerance level and that 100 percent of the crop is treated by pesticides that
have established tolerances. If the TMRC exceeds the RfD or poses a lifetime
cancer risk that is greater than approximately one in a million, EPA attempts
to derive a more accurate exposure estimate for the pesticide by evaluating
additional types of information (anticipated residue data and/or percent of
crop treated data) which show, generally, that pesticide residues in most
foods when they are eaten are well below established tolerances.
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.
Clopyralid is already registered by EPA for outdoor Christmas tree
plantations, grasses grown for seed, fallow cropland, non-cropland and other
non-food uses, as well as several food use registrations. EPA believes it has
sufficient data to assess the hazards of clopyralid and to make a
determination on aggregate exposure, consistent with section 408(b)(2), for
the time-limited tolerances for residues of clopyralid in or on cranberries at
2 ppm. EPA's assessment of the dietary exposures and risks associated with
establishing this tolerance follows.
A. Toxicological Profile
1. Chronic toxicity. Based on the available chronic toxicity data, the EPA's
Office of Pesticide Programs (OPP) has established the RfD for clopyralid at
0.5 milligrams/kilogram/day (mg/kg/day). The RfD was established based on an
NOEL of 50 mg/kg/day from a 2-year rat feeding study. Effects observed at the
lowest effect level (LEL) were decreased mean body weights in females. An
uncertainty factor of 100 was used.
2. Acute toxicity. No toxicology studies were identified by OPP which
demonstrated the need for an acute dietary risk assessment.
3. Short-term non-dietary inhalation and dermal toxicity. Based on available
data indicating that there was no evidence of toxicity by the dermal or
inhalation routes, worker exposure risks were not calculated.
4. Carcinogenicity. No evidence of carcinogenicity was seen in mice or in rats
fed clopyralid for 24 months.
B. Aggregate Exposure
Tolerances are established for residues of clopyralid (3,6- dichloro-2-
pyridinecarboxylic acid) in or on several raw agricultural commodities (40 CFR
180.431(a) and (b)).
For the purpose of assessing chronic dietary exposure from clopyralid, EPA
assumed tolerance level residues and 100% of crop treated for the proposed and
existing food uses of clopyralid.
These conservative assumptions result in overestimation of human dietary
exposures.
Other potential sources of exposure of the general population to residues of
pesticides are residues in drinking water and exposure from non-occupational
sources. There is no entry for clopyralid in the "Pesticides in Groundwater
Data Base" (EPA 734-12-92-001, September 1992). There is no established
Maximum Concentration Level (MCL) for residues of clopyralid in drinking
water. No drinking water health advisory levels have been established for
clopyralid.
The Agency does not have available data to perform a quantitative drinking
water risk assessment for clopyralid at this time. Previous experience with
persistent and mobile pesticides for which there have been available data to
perform quantitative risk assessments have demonstrated that drinking water
exposure is typically a small percentage of the total exposure. This
observation holds even for pesticides detected in wells and drinking water at
levels nearing or exceeding established MCLs. Based on this experience and the
OPP's best scientific judgement, EPA concludes that it is not likely that the
potential exposure from residues of clopyralid in drinking water added to the
current dietary exposure will result in an exposure which exceeds the RfD.
Clopyralid is registered for uses, such as lawns, that could result in non-
occupational exposure and EPA acknowledges that there may be short-,
intermediate-, and long-term non-occupational, non-dietary exposure scenarios.
At this time, the Agency has insufficient information to assess the potential
risks from such exposure. However, available data for clopyralid indicate no
evidence of toxicity by the dermal or inhalation routes. Given the time-
limited nature of this request, the need to make emergency exemption decisions
quickly, and the significant scientific uncertainty at this time about how to
aggregate non-occupational exposure with dietary exposure, the Agency will
make its safety determination for this tolerance based on those factors which
it can reasonably integrate into a risk assessment.
At this time, the Agency has not made a determination that clopyralid and
other substances that may have a common mode of toxicity would have cumulative
effects. Clopyralid is a member of the pyridinoxy class of herbicides. Other
members of this class include fluroxypyr, tricolpyr, and picloram. Given the
time limited nature of this request, the need to make emergency exemption
decisions quickly, and the significant scientific uncertainty at this time
about how to define common mode of toxicity EPA will make its safety
determination for these tolerances based on those factors which can reasonably
integrate into a risk assessment. For purposes of this tolerance only, the
Agency is considering only the potential risks of clopyralid in its aggregate
exposure.
C. Safety Determinations For U.S. Population
Taking into account the completeness and reliability of the toxicity data, EPA
has concluded that dietary exposure to clopyralid from published tolerances
will utilize 1.65 percent of the RfD for the U.S. population. EPA does not
anticipate that the potential exposure from residues of clopyralid in drinking
water added to the current dietary exposure will result in a chronic exposure
which would exceed 100% of the RfD. EPA concludes that there is a reasonable
certainty that no harm will result from aggregate exposure to clopyralid
residues.
D. Determination of Safety for Infants and Children
Based on current toxicological data requirements, the data base for clopyralid
relative to pre- and post-natal toxicity is complete. EPA notes that the
developmental toxicity NOELs of >250 mg/kg/day, the highest dose tested (HDT)
in both rats and rabbits demonstrate that there is no developmental (prenatal)
toxicity present for clopyralid. EPA further notes that the developmental
NOELs are 5-fold higher in both rats and rabbits, respectively, than the NOEL
of 50 mg/kg/day from the 2-year feeding study in rats, which is the basis for
the RfD.
>In the two-generation reproductive toxicity study in rats, the pup toxicity
NOEL of 1,500 mg/kg/day, the HDT, was greater than the parental (systemic)
toxicity NOEL of 500 mg/kg/day. This finding suggests that post-natal
development in pups is not more sensitive and that infants and children may
not be more sensitive to clopyralid than adult animals. The pup NOEL is 30-
fold higher than the RfD NOEL of 50 mg/kg/day. This information, together with
the uncertainty factor of 100 utilized to calculate the RfD for clopyralid, is
considered adequate protection for infants and children with respect to
prenatal and postnatal development against dietary exposure to clopyralid
residues. EPA believes that the data base of clopyralid is sufficiently
complete regarding infants and children and that effects seen in that data are
not such to suggest a 100-fold uncertainty factor will be inadequate.
Therefore, EPA has determined that an additional 10-fold safety factor is not
appropriate and that the 100-fold uncertainty factor will be safe for infants
and children.
EPA has concluded that the percent of the RfD that will be utilized by chronic
dietary exposure to residues of clopyralid ranges from 1.07% for nursing
infants (<1 year old) up to 3.72% for children 1 to 6 years old. However, this
calculation assumes tolerance level residues for all commodities and is
therefore an over-estimate of dietary risk. Refinement of the dietary risk
assessment by using anticipated residue data would reduce dietary exposure.
The addition of potential exposure from clopyralid residues in drinking water
is not expected to result in an exposure which would exceed the RfD.
V. Other Considerations
The metabolism of clopyralid in plants and animals is adequately understood
for the purposes of this tolerance. There are no Codex maximum residue levels
established for residues of clopyralid on cranberries. The residue of concern
is clopyralid (3,6-dichloro-2- pyridinecarboxylic acid). Adequate methods for
purposes of data collection and enforcement of tolerances for clopyralid are
available. A method for determining clopyralid residues is described in PAM,
Vol. II.
VI. Conclusion
Therefore, tolerances in connection with the FIFRA section 18 emergency
exemptions are established for residues of clopyralid in cranberries at 2 ppm.
This tolerance will expire on July 31, 1998.
VII. 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 May 12, 1997, file written objections to any aspect of this
regulation (including the automatic revocation provision) 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.
VIII. Public Docket
A record has been established for this rulemaking under docket number [OPP-
300458]. A public version of this record, 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 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, is kept in paper form. Accordingly, in the event there are
objections and hearing requests, 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. The official rulemaking record is the paper record maintained at the
address in "ADDRESSES" at the beginning of this document.
IX. 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).
Because FFDCA section 408(l)(6) permits establishment of this regulation
without a notice of proposed rulemaking, the regulatory flexibility analysis
requirements of the Regulatory Flexibility Act, 5 U.S.C. 604(a), do not apply.
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 of the rule 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: February 27, 1997.
Peter Caulkins,
Acting Director, 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. 180.431, by adding a new paragraph (c) to read as follows:
Sec. 180.431 Clopyralid; tolerances for residues.
(c) Section 18 emergency exemptions. A time-limited tolerance is established
for residues of the herbicide clopyralid (3,6-dichloro-2- pyridinecarboxylic
acid) in connection with use of the pesticide under section 18 emergency
exemptions granted by EPA. The tolerance is specified in the following table.
The tolerance expires on the date specified in the table.
------------------------------------------------------------------------
Commodity                  Parts per million          Expiration Date
------------------------------------------------------------------------
Cranberries........................2....................July 31, 1998
------------------------------------------------------------------------
[FR Doc. 97-5875 Filed 3-11-97; 8:45 am] BILLING CODE 6560-50-F