to FDA and to its accreditation body (where applicable) under Sec.
1.656(a); and
    (6) Allow FDA and the recognized accreditation body that accredited
such third-party auditor/certification body, if any, to observe any
food safety audit for purposes of evaluating the accredited auditor's/
certification body's performance under Sec. Sec.  1.621 and 1.662 or,
where appropriate, the recognized accreditation body's performance
under Sec. Sec.  1.622 and 1.633.
    (c) Audit protocols. An accredited auditor/certification body (or
its audit agent, where applicable) must conduct a food safety audit in
a manner consistent with the identified scope and purpose of the audit
and within the scope of its accreditation.
    (1) The audit must be conducted without announcement during the 30-
day timeframe identified under paragraph (a)(1)(ii) of this section and
must be focused on the highest food safety risk(s) associated with the
facility, its process(es), and food within the scope of the audit.
    (2) The audit must include records review; an onsite assessment of
the facility, its process(es), and the food that results from such
process(es); and where appropriate, environmental or product sampling
and analysis, using validated procedures (including sample integrity
procedures) and analysis performed by a laboratory accredited in
accordance with the requirements of section 422 of the FD&C Act. The
audit may include any other activities necessary to establish
compliance with the FD&C Act.
    (3) The audit must be sufficiently rigorous to allow the accredited
auditor/certification body to determine whether the entity is in
compliance with the FD&C Act at the time of the audit; and for a
regulatory audit, whether the entity would be likely to remain in
compliance with the applicable requirements of the FD&C Act for at
least 12 months following the audit, provided that the facility and its
process(es) are properly maintained and implemented.
    (4) Audit observations and assessments, including corrective
actions, must be documented and must be used to support the findings
contained in the audit report required by Sec.  1.652 and maintained as
a record of the accredited auditor/certification body under Sec.
1.658.

Sec.  1.652  What must an accredited auditor/certification body include
in food safety audit reports?

    (a) Consultative audits. An accredited auditor/certification body
must prepare a report of a consultative audit, in English, not later
than 45 days after completing such audit and must maintain such report
under Sec.  1.658. A consultative audit report must include:
    (1) The name and address of the facility subject to audit and the
name and address of the eligible entity, if different from the
facility;
    (2) A unique facility identifier, as required by FDA, for the
facility and for the eligible entity, if different from the facility;
    (3) The names and telephone numbers of the persons responsible for
food safety compliance at the facility;
    (4) The dates and scope of the audit; and
    (5) Any deficiencies observed that require corrective action, the
corrective action plan, and the date on which such corrective actions
were completed. Such audit report must be maintained as a record under
Sec.  1.658 and must be made available to FDA under Sec.  1.361.
    (b) Regulatory audits. An accredited auditor/certification body
must, no later than 45 days after completing a regulatory audit,
prepare and submit electronically, in English, to FDA and to its
accreditation body (or, in the case of direct accreditation, only to
FDA) a report of such regulatory audit that includes the following
information:
    (1) The identity of the audited facility, including:
    (i) The name and address of the facility subject to audit and a
unique facility identifier, as required by FDA; and
    (ii) Where applicable, the FDA registration number assigned to the
facility under subpart H of this part;
    (2) The identity of the eligible entity, including the name,
address, and unique facility identifier, as required by FDA, of the
eligible entity (if different than that of facility);
    (3) The dates and scope of the regulatory audit;
    (4) The process(es) and food(s) observed during such audit;
    (5) The identity of the person(s) responsible for the facility's
compliance with the applicable requirements of the FD&C Act;
    (6) Any deficiencies observed during the audit that present a
reasonable probability that the use of or exposure to a violative
product:
    (i) Will cause serious adverse health consequences or death; or
    (ii) May cause temporary or medically reversible adverse health
consequences or where the probability of serious adverse health
consequences is remote;
    (7) The corrective action plan for addressing each deficiency
identified under paragraph (b)(6) of this section, unless corrective
action was implemented immediately and verified onsite by the
accredited auditor/certification body (or its audit agent);
    (8) Whether any sampling and laboratory analysis (e.g., under a
microbiological sampling plan) is used in the facility;
    (9) Whether the entity has issued a food safety-related recall of
an article of food from the facility during the 2 years preceding the
audit and, if so, any such article(s) recalled and the reason(s) for
the recall(s);
    (10) Whether the entity has made significant changes to the
facility, its process(es), or products during the 2 years preceding the
audit; and
    (11) Any food or facility certifications issued to the entity
during the 2 years preceding the audit, including the scope and
duration of each such certification.
    (c) Submission of regulatory audit report. An accredited auditor/
certification body must submit a completed regulatory audit report as
required by paragraph (b) of this section, regardless of whether the
food or facility certification was issued under this subpart.
    (d) Appeals of adverse regulatory audit results. An accredited
auditor/certification body must implement written procedures for
receiving and addressing appeals from eligible entities challenging
adverse regulatory audit results and for investigating and deciding on
appeals in a fair and meaningful manner. The appeals procedures must
provide similar protections to those offered by FDA under Sec. Sec.
1.692 and 1.693, including requirements to:
    (1) Make the appeals procedures publicly available;
    (2) Use qualified persons, different from those involved in the
subject of the appeal, to investigate and decide on an appeal;
    (3) Advise the eligible entity of the final decision on its appeal;
and
    (4) Maintain records under Sec.  1.658 of the appeal, the final
decision, and the basis for such decision.

Sec.  1.653  What must accredited auditor/certification body do when
issuing food or facility certifications?

    (a) Basis for issuance of a food or facility certification. (1)
Prior to issuing a food or facility certification to an eligible
entity, an accredited auditor/certification body (or an audit agent on
its behalf) must complete a regulatory

audit that meets the requirements of Sec.  1.651 and any other
activities that may be necessary to establish compliance with
applicable requirements of the FD&C Act.
    (2) If, as a result of an observation during a regulatory audit, an
eligible entity must implement a corrective action plan to address an
observation, an accredited auditor/certification body may not issue a
food or facility certification to such entity until after the
accredited auditor/certification body verifies that eligible entity has
implemented the corrective action plan through onsite observation,
except for corrective actions taken to address recordkeeping
deficiencies that may be verified through submission of records or
through assurances by the eligible entity.
    (3) An accredited auditor/certification body must consider each
observation and assessment made during a regulatory audit and other
activities conducted under Sec.  1.651 to determine whether the entity
was in compliance with the applicable requirements of the FD&C Act at
the time of the audit and whether the entity would be likely to remain
in compliance for the duration of a food or facility certification
issued under this subpart.
    (4) A single regulatory audit may result in issuance of one or more
food or facility certifications under this subpart, provided that the
requirements of issuance are met as to each such certification.
    (5) Where an accredited auditor/certification body uses an audit
agent to conduct a regulatory audit of an eligible entity under this
subpart, the accredited auditor/certification body (and not the audit
agent) must make the determination whether to issue a food or facility
certification based on the results of such regulatory audit.
    (b) Issuance of a food or facility certification and submission to
FDA. (1) For purposes of submission to FDA under this subpart, an
accredited auditor/certification body must issue a food or facility
certification electronically and in English. The accredited auditor/
certification body must not issue a food or facility certification
under this subpart for a term that is longer than 12 months.
    (2) A food or facility certification must contain, at a minimum,
the following elements:
    (i) The name and address of the accredited auditor/certification
body and the scope and date of its accreditation under this subpart;
    (ii) The name, address, and unique facility identifier, as required
by FDA, of the eligible entity to which the food or facility
certification was issued;
    (iii) The name, address, and unique facility identifier, as
required by FDA, of the facility where the audit was conducted, if
different than the eligible entity;
    (iv) The scope and date(s) of the audit;
    (v) The name of the audit agent(s) (where applicable) conducting
the audit;
    (vi) The scope of the food or facility certification, date of
issuance, and date of expiration.
    (3) FDA may refuse to accept any food certification or other
assurance for food issued by an accredited auditor/certification body
for purposes of section 801(q) of the FD&C Act, if FDA determines,
under section 801(q)(4)(B), that such food certification or assurance
was not validly issued or does not reliably demonstrate that the food
is in compliance with the applicable requirements of the FD&C Act,
including the following:
    (i) That the food certification or assurance is offered in support
of the admissibility of a food that was not within the scope of the
certification or assurance; and
    (ii) That the food certification was issued by an accredited
auditor/certification body acting outside the scope of its
accreditation under this subpart.

Sec.  1.654  When must an accredited auditor/certification body monitor
an eligible entity with food or facility certification?

    If an accredited auditor/certification body has reason to believe
that an eligible entity to which it issued a food or facility
certification may no longer be in compliance with the applicable
requirements of the FD&C Act, the accredited auditor/certification body
must conduct any monitoring (including an onsite assessment) of such
eligible entity necessary to determine whether the entity is in
compliance. The accredited auditor/certification body must immediately
notify FDA, under Sec.  1.656(d), if it determines the entity is no
longer in compliance with the applicable requirements of the FD&C Act.
The accredited auditor/certification body must maintain records of such
monitoring under Sec.  1.658.

Sec.  1.655  How must an accredited auditor/certification body monitor
its own performance?

    (a) An accredited auditor/certification body must annually, and as
required under Sec.  1.634(d)(1)(i) or upon FDA request made for cause,
conduct a self-assessment that includes evaluation of:
    (1) The performance of its officers, personnel, or other agents in
activities under this subpart, including assessing whether its audit
agents focused on the most significant risks to human and/or animal
health when conducting food safety audits of facilities involved in the
production, manufacturing, processing, packing, or holding of food;
    (2) The degree of consistency among its officers, personnel, or
other agents in performing activities under this subpart, including
assessing whether its audit agents interpreted audit protocols in a
consistent manner;
    (3) The compliance of the accredited auditor/certification body and
its officers, personnel, and other agents, with the conflict of
interest requirements of Sec.  1.657;
    (4) Actions taken in response to the results of any assessments
conducted by FDA or, where applicable, the recognized accreditation
body under Sec.  1.621; and
    (5) As requested by FDA, any other aspects of its performance
relevant to a determination whether the accredited auditor/
certification body is in compliance with this subpart.
    (b) As a means to evaluate its performance, the accredited auditor/
certification body may evaluate the compliance of one or more of
eligible entities to which food or facility certification was issued
under this subpart.
    (c) Based on the evaluations conducted under paragraphs (a) and (b)
of this section, the accredited auditor/certification body must:
    (1) Identify any area(s) needing improvement;
    (2) Quickly implement effective corrective action(s) to address
those area(s); and
    (3) Under Sec.  1.658, establish and maintain records of such
corrective action(s).
    (d) The accredited auditor/certification body must prepare a
written report, in English, of the results of its self-assessment that
includes:
    (1) A description of any corrective action(s) taken under paragraph
(c) of this section;
    (2) A statement disclosing the extent to which the accredited
auditor/certification body, and its officers, personnel, and other
agents complied with the conflict of interest requirements in Sec.
1.657; and
    (3) A statement attesting to the extent to which the accredited
auditor/certification body complied with the applicable requirements of
this subpart.

Sec.  1.656  What reports and notifications must an accredited auditor/
certification body submit?

    (a) Reporting results of regulatory audits. An accredited auditor/

certification body must submit a regulatory audit report, as described
in Sec.  1.652(b), electronically, in English, to FDA and to the
accreditation body that granted its accreditation (where applicable),
no later than 45 days after completing such audit.
    (b) Reporting results of accredited auditor/certification body
self-assessments. An accredited auditor/certification body must submit
the report of its annual self-assessment required by Sec.  1.655
electronically to its accreditation body (or, in the case of direct
accreditation, FDA), within 45 days of the anniversary date of its
accreditation under this subpart and, for an accredited auditor/
certification body subject to Sec.  1.634(d)(1)(i) or an FDA request
for cause, must submit the report of its self-assessment to FDA within
2 months. Such report must include an up-to-date list of any audit
agents it uses to conduct audits under this subpart.
    (c) Notification to FDA of a serious risk to public health. An
accredited auditor/certification body must immediately notify FDA
electronically, in English, when any of its audit agents or the
accredited auditor/certification body itself, discovers any condition,
found during a regulatory or consultative audit of an eligible entity,
which could cause or contribute to a serious risk to the public health,
providing the following information:
    (1) The name and address of the eligible entity subject to the
audit;
    (2) The name and address of the facility where the condition was
discovered (if different from that of the eligible entity) and, where
applicable, the FDA registration number assigned to the facility under
subpart H of this part; and
    (3) The condition for which notification is submitted.
    (d) Immediate notification to FDA of withdrawal or suspension of
food or facility certification. An accredited auditor/certification
body must notify FDA electronically, in English, immediately upon
withdrawing or suspending the food or facility certification of an
eligible entity and the basis for such action.
    (e) Notification to its accreditation body or an eligible entity.
(1) After notifying FDA under paragraph (c) of this section, an
accredited auditor/certification body must immediately notify the
eligible entity of such condition and must immediately thereafter
notify the accreditation body that granted its accreditation, except
for auditors/certification bodies directly accredited by FDA.
    (2) An accredited auditor/certification body must notify its
accreditation body (or, in the case of direct accreditation, FDA)
electronically, in English, within 30 days after making any significant
change that would affect the manner in which it complies with the
requirements of Sec. Sec.  1.640 to 1.658, and must include with such
notification the following information:
    (i) A description of the change; and
    (ii) An explanation for the purpose of the change.

Sec.  1.657  How must an accredited auditor/certification body protect
against conflicts of interest?

    (a) An accredited auditor/certification body must implement a
written program to protect against conflicts of interest between the
accredited auditor/certification body (and its officers, personnel, and
agents) and an eligible entity seeking a food safety audit or food or
facility certification from, or audited or certified by, such
accredited auditor/certification body, including the following:
    (1) Ensuring that the accredited auditor/certification body and its
officers, personnel, or agents (other than audit agents subject to
paragraph (a)(2) of this section) do not own or have a financial
interest in, manage, or otherwise control an eligible entity to be
certified, or any affiliate, parent, or subsidiary of the entity;
    (2) Ensuring that an audit agent of the accredited auditor/
certification body does not own or operate an eligible entity, or any
affiliate, parent, or subsidiary of the entity, to be subject to
consultative or regulatory audit by such agent; and
    (3) Prohibiting an officer, employee, or other agent of the
accredited auditor/certification body from accepting any money, gift,
gratuity, or item of value from the eligible entity to be audited or
certified under this subpart.
    (4) The items specified in paragraph (a)(3) of this section do not
include:
    (i) Money representing payment of fees for accreditation services
and reimbursement of direct costs associated with an onsite audit or
assessment of the third-party auditor/certification body; or
    (ii) Meals, of de minimis value, provided on the premises where the
audit or assessment is conducted.
    (b) An accredited auditor/certification body may accept the payment
of fees for auditing and certification services and the reimbursement
of direct costs associated with an audit of an eligible entity only
after the date on which the report of such audit was completed or the
date a food or facility certification was issued, whichever is later.
Such payment is not considered a conflict of interest for purposes of
paragraph (a) of this section.
    (c) The financial interests of the spouses and children younger
than 18 years of age of officers, personnel, and other agents of an
accredited auditor/certification body will be considered the financial
interests of such officers, personnel, and other agents of the
accredited auditor/certification body for purposes of this subpart.
    (d) An accredited auditor/certification body must maintain on its
Web site an up-to-date list of the eligible entities to which it has
issued food or facility certifications under this subpart. For each
such eligible entity, the Web site also must identify the duration and
scope of the food or facility certification and date(s) on which the
eligible entity paid the accredited auditor/certification body any fee
or reimbursement associated with such audit or certification.

Sec.  1.658  What records requirements must an accredited auditor/
certification body meet?

    (a) An accredited auditor/certification body must maintain
electronically for 4 years records (including documents and data), in
English, that document compliance with this subpart, including:
    (1) Any audit report and other documents resulting from a
consultative audit conducted under this subpart, including the audit
agent's observations, laboratory testing records and results (as
applicable), correspondence with the eligible entity, and corrective
actions to address deficiencies identified during the audit;
    (2) Any request for a regulatory audit from an eligible entity;
    (3) Any audit report and other documents resulting from a
regulatory audit conducted under this subpart, including the audit
agent's observations, laboratory testing records and results (as
applicable), correspondence with the eligible entity, and corrective
actions to address deficiencies identified during the audit;
    (4) Any notification submitted by an audit agent to the accredited
auditor/certification body under Sec.  1.650(a)(5) or by the accredited
auditor/certification body to FDA under Sec.  1.656(c);
    (5) Any food or facility certification issued under this subpart;
    (6) Any challenge to an adverse regulatory audit decision and the
disposition of the challenge;
    (7) Any monitoring it conducted of an eligible entity to which food
or facility certification was issued;

    (8) Its self-assessments and corrective actions taken as a result;
and
    (9) Significant changes to the auditing or certification program
that might affect compliance with this subpart.
    (b) An accredited auditor/certification body must make the records
of a consultative audit required by paragraph (a)(1) of this section
available to FDA in accordance with the requirements of subpart J of
this chapter.
    (c) An accredited auditor/certification body must make the records
required by paragraphs (a)(2) to (a)(9) of this section available for
inspection and copying promptly upon written request of an authorized
FDA officer or employee at the place of business of the auditor/
certification body or at a reasonably accessible location. If such
records are requested by FDA electronically, the records must be
submitted electronically, in English, not later than 10 business days
after the date of the request.

Procedures for Accreditation of Third-Party Auditors/Certification
Bodies Under This Subpart

Sec.  1.660  Where do I apply for accreditation or renewal of
accreditation by a recognized accreditation body?

    Except as allowed under Sec.  1.670, a third-party auditor/
certification body seeking accreditation must submit its request for
accreditation or renewal of accreditation to an accreditation body
recognized by FDA under this subpart and identified on the Web site
described in Sec.  1.690.

Sec.  1.661  What is the duration of accreditation?

    A recognized accreditation body may grant accreditation to a third-
party auditor/certification body under this subpart for a period not to
exceed 4 years.

Sec.  1.662  How will FDA monitor accredited auditors/certification
bodies?

    (a) FDA will periodically evaluate the performance of each auditor/
certification body accredited under this subpart to determine whether
the accredited auditor/certification body continues to comply with the
requirements of Sec. Sec.  1.640 to 1.658 and whether there are
deficiencies in the performance of the accredited auditor/certification
body that, if not corrected, would warrant withdrawal of its
accreditation under this subpart. FDA will evaluate each directly
accredited auditor/certification body annually. FDA will evaluate an
accredited auditor/certification body annually evaluated by a
recognized accreditation body under Sec.  1.621 by not later than 3
years after the date of accreditation for a 4-year term of
accreditation, or by no later than the mid-term point for accreditation
granted for less than 4 years. FDA may conduct additional performance
evaluations of an accredited auditor/certification body at any time.
    (b) In evaluating the performance of an accredited auditor/
certification body under paragraph (a) of this section, FDA may review
any one or more of the following:
    (1) Regulatory audit reports and food and facility certifications;
    (2) The accredited auditor's/certification body's annual self-
assessments under Sec.  1.655;
    (3) Reports of assessments by a recognized accreditation body under
Sec.  1.621, where applicable;
    (4) Documents and other information regarding the accredited
auditor's/certification body's authority, qualifications (including the
expertise and training of its audit agents), conflict of interest
program, internal quality assurance program, and monitoring by its
accreditation body (or, in the case of direct accreditation, FDA); and
    (5) Information obtained by FDA, including during inspections,
audits, onsite observations, or investigations, of one or more eligible
entities to which food or facility certification was issued by such
accredited auditor/certification body.
    (c) FDA may conduct its evaluation of an accredited auditor/
certification body through onsite observations of performance during a
food safety audit of an eligible entity or through document review.

Sec.  1.663  How do I request an FDA waiver or waiver extension for the
13-month limit for audit agents conducting regulatory audits?

    (a) An accredited auditor/certification body may submit a request
to FDA to waive the requirements of Sec.  1.650(c) preventing an audit
agent from conducting a regulatory audit of an eligible entity if the
agent has conducted a food safety audit of such entity during the
previous 13 months. The auditor/certification body seeking a waiver or
waiver extension must demonstrate there is insufficient access to
accredited auditors/certification bodies in the country or region where
the eligible entity is located.
    (b) Requests for a waiver or waiver extension and all documents
provided in support of the request must be submitted to FDA
electronically, in English. The requestor must provide such translation
and interpretation services as are needed by FDA to process the
request.
    (c) The request must be signed by the requestor or by any
individual authorized to act on behalf of the requestor for purposes of
seeking such waiver or waiver extension.
    (d) FDA will review requests for waivers and waiver extensions on a
first in, first out basis according to the date on which the submission
was completed. FDA will evaluate any completed waiver request to
determine whether the criteria for waiver have been met.
    (e) FDA will notify the requestor, in writing, whether the request
for a waiver or waiver extension is approved or denied. Such
notification may be made electronically.
    (f) If FDA approves the request, the notification will state the
duration of the waiver and list any conditions associated with it. If
FDA denies the request, the notification will state the basis for
denial and will provide the address and procedures for requesting
reconsideration of the request under Sec.  1.691.
    (g) Unless FDA notifies a requestor that its waiver request has
been approved, an accredited auditor/certification body must not use
the agent to conduct a regulatory audit of such eligible entity until
the 13-month limit in Sec.  1.650(a) has elapsed.

Sec.  1.664  When can FDA withdraw accreditation?

    (a) Mandatory withdrawal. FDA will withdraw accreditation from an
auditor/certification body:
    (1) Except as provided in paragraph (b) of this section, if the
food or facility certified under this subpart is linked to an outbreak
of foodborne illness that has a reasonable probability of causing
serious adverse health consequences or death in humans or animals;
    (2) Following an evaluation and finding by FDA that the auditor/
certification body no longer meets the requirements for accreditation;
or
    (3) Following its refusal to allow FDA to access records under
Sec.  1.658 or to conduct an audit, assessment, or investigation
necessary to ensure continued compliance with this subpart.
    (b) Exception. FDA may waive mandatory withdrawal under paragraph
(a)(1) of this section, if FDA:
    (1) Conducts an investigation of the material facts related to the
outbreak of human or animal illness;
    (2) Reviews the steps or actions taken by the accredited auditor/
certification body to justify the food or facility certification; and
    (3) Determines that the accredited auditor/certification body
satisfied the

requirements for issuance of certification under sections 801(q) or 806
of the FD&C Act, as applicable, and under this subpart.
    (c) Discretionary withdrawal. FDA may withdraw accreditation from
an auditor/certification body when such auditor/certification body is
accredited by an accreditation body for which recognition is revoked
under Sec.  1.634, if FDA determines there is good cause for
withdrawal, including:
    (1) Demonstrated bias or lack of objectivity when conducting
activities under this subpart; or
    (2) Performance that calls into question the validity or
reliability of its food safety audits and food and facility
certifications.
    (d) Records access. FDA may request records of the accredited
auditor/certification body under Sec.  1.658 and, where applicable, may
request records of the recognized accreditation body under Sec.  1.625,
when considering withdrawal under paragraphs (a)(1), (a)(2), or (c) of
this section.
    (e) Notice to the auditor/certification body of withdrawal of
accreditation. (1) FDA will notify the auditor/certification body of
the withdrawal electronically, in English, stating the grounds for
withdrawal, the procedures for requesting a regulatory hearing under
Sec.  1.693 on the withdrawal, and the procedures for requesting
reaccreditation under Sec.  1.666.
    (2) Within 10 business days of the date of withdrawal, the auditor/
certification body must notify FDA electronically, in English, of the
location where the records will be maintained as required by Sec.
1.658.
    (f) Effect of withdrawal of accreditation on eligible entities. A
food or facility certification issued by third-party auditor/
certification body prior to withdrawal will remain in effect until the
certification terminates by expiration. If FDA has reason to believe
that a food certification issued for purposes of section 801(q) of the
FD&C Act is not valid or reliable, FDA may refuse to consider the
certification in determining the admissibility of the article of food
for which the certification was offered.
    (g) Effect of withdrawal of accreditation on recognized
accreditation bodies. (1) FDA will notify a recognized accreditation
body, electronically and in English, if the accreditation of one of its
auditors/certification bodies is withdrawn. Such accreditation body's
recognition will remain in effect if, no later than 2 months after
withdrawal, the accreditation body conducts a self-assessment under
Sec.  1.622 and reports the results of the self-assessment to FDA as
required by Sec.  1.623(b).
    (2) FDA may revoke the recognition of such accreditation body
whenever FDA determines there is good cause for revocation of
recognition under Sec.  1.634.
    (h) Public notice of withdrawal and the status of recognition and
food and facility certifications. FDA will provide notice on the Web
site described in Sec.  1.690 of its withdrawal of accreditation of an
auditor/certification body under this subpart.

Sec.  1.665  How do I voluntarily relinquish accreditation?

    (a) An accredited auditor/certification body that decides to
relinquish accreditation before it terminates by expiration must notify
the accreditation body (where applicable) and must notify FDA
electronically, in English, at least 6 months before relinquishing such
authority. The notice must identify the location where the records will
be maintained as required by Sec.  1.658. A third-party auditor/
certification body waives the right to a hearing when relinquishing its
accreditation under this subpart.
    (b) No later than 15 business days after notifying FDA under
paragraph (a) of this section, the accredited auditor/certification
body must notify any eligible entity to which it issued food or
facility certification under this subpart.
    (c) A food or facility certification issued by an accredited
auditor/certification body prior to relinquishing its accreditation
will remain in effect until terminated by expiration. If FDA has reason
to believe that a certification issued for purposes of section 801(q)
of the FD&C Act is not valid or reliable, FDA may refuse to consider
the certification in determining the admissibility of the article of
food for which the certification was offered.
    (d) FDA will provide notice on the Web site described in Sec.
1.690 of the voluntary relinquishment of accreditation by an auditor/
certification body.

Sec.  1.666  How do I request reaccreditation?

    (a) Application following withdrawal. FDA will reinstate the
accreditation of an auditor/certification body for which it has
withdrawn accreditation:
    (1) If, in the case of direct accreditation, FDA determines, based
on evidence presented by the auditor/certification body, that the
auditor/certification body satisfies the requirements for accreditation
and adequate grounds for withdrawal no longer exist; or
    (2) In the case of an auditor/certification body accredited by an
accreditation body for which recognition has been revoked under Sec.
1.634:
    (i) If the auditor/certification body becomes accredited by a
recognized accreditation body or by FDA through direct accreditation
not later than 1 year after withdrawal of accreditation; or
    (ii) Under such conditions as FDA may impose in withdrawing
accreditation.
    (b) Application following relinquishment. An auditor/certification
body that previously relinquished its accreditation under Sec.  1.665
may seek accreditation by submitting a new application for
accreditation under Sec.  1.660 or, where applicable, Sec.  1.670.

Additional Procedures for Direct Accreditation of Third-Party Auditors/
Certification Bodies Under This Subpart

Sec.  1.670  How do I apply to FDA for direct accreditation or renewal
of direct accreditation?

    (a) Eligibility. (1) FDA will accept applications from third-party
auditors/certification bodies for direct accreditation or renewal of
direct accreditation only if FDA determines that it has not identified
and recognized an accreditation body to meet the requirements of
section 808 of the FD&C Act within 2 years after establishing the
accredited third-party audits and certification program. Such FDA
determination may apply, as appropriate, to specific types of auditor/
certification bodies, types of expertise, or geographic location; or
through identification by FDA of any requirements of section 808 of the
FD&C Act not otherwise met by previously recognized accreditation
bodies. FDA will only accept applications for direct accreditation and
renewal applications that are within the scope of the determination.
    (2) FDA may revoke or modify a determination under paragraph (a)(1)
of this section if FDA subsequently identifies and recognizes an
accreditation body that affects such determination.
    (3) FDA will provide notice on the Web site described in Sec.
1.690 of a determination under paragraph (a)(1) of this section and of
a revocation or modification of the determination under paragraph
(a)(2) of this section.
    (b) Application for direct accreditation or renewal of direct
accreditation. (1) An auditor/certification body seeking direct
accreditation or renewal of direct accreditation must submit an
application to FDA, demonstrating that it is within the scope of the

determination issued under paragraph (a) of this section, and it meets
the eligibility requirements of Sec.  1.640.
    (2) Applications and all documents provided as part of the
application process must be submitted electronically, in English. An
applicant must provide such translation and interpretation services as
are needed by FDA to process the application, including during an
onsite audit of the applicant.
    (3) The application must be signed by the applicant or by any
individual authorized to act on behalf of the applicant for purposes of
seeking or renewing direct accreditation.

Sec.  1.671  How will FDA review applications for direct accreditation
and for renewal of direct accreditation?

    (a) FDA will review applications for direct accreditation and for
renewal of direct accreditation on a first in, first out basis
according to the date the submission was completed.
    (b) FDA will evaluate any completed application to determine
whether the applicant meets the requirements for direct accreditation
under this subpart.
    (c) FDA will notify the applicant in writing whether the
application has been approved or denied. FDA may provide such
notification electronically.
    (d) If an application has been approved, the notification will list
any conditions associated with the accreditation.
    (e) If FDA denies an application, the notification will state the
basis of denial and will provide the address and procedures for
requesting reconsideration of the application under Sec.  1.691.
    (f) If FDA does not reach a final decision on a renewal application
before the expiration of its direct accreditation, FDA may extend the
duration of such direct accreditation for a specified period of time or
until the agency reaches a final decision on the renewal application.

Sec.  1.672  What is the duration of direct accreditation?

    FDA will grant direct accreditation of a third-party auditor/
certification body for a period not to exceed 4 years.

Requirements for Eligible Entities Under This Subpart

Sec.  1.680  How and when will FDA monitor eligible entities?

    (a) FDA may, at any time, conduct an onsite audit of an eligible
entity that has received food or facility certification from an
accredited auditor/certification body under this subpart. The audit may
be conducted with or without the accredited auditor/certification body
or the recognized accreditation body (where applicable) present.
    (b) A food safety audit conducted by an accredited auditor/
certification body under this subpart is not considered an inspection
under section 704 of the FD&C Act.

Sec.  1.681  How frequently must eligible entities be recertified?

    (a) An eligible entity seeking to maintain facility certification
under this subpart must seek recertification prior to expiration of its
certification. To obtain recertification, the eligible entity must
demonstrate its continuing compliance with the applicable requirements
of the FD&C Act.
    (b) FDA may require an eligible entity to renew a food
certification at any time FDA determines appropriate under section
801(q)(4)(A) of the FD&C Act.

General Requirements of This Subpart

Sec.  1.690  How will FDA make information about recognized
accreditation bodies and accredited auditors/certification bodies
available to the public?

    FDA will place on its Web site a registry of recognized
accreditation bodies and accredited auditors/certification bodies,
including the name and contact information for each. The registry may
provide information on auditors/certification bodies accredited by
recognized accreditation bodies through links to the Web sites of such
accreditation bodies.

Sec.  1.691  How do I request reconsideration of a denial by FDA of an
application or a waiver request?

    (a) An accreditation body may seek reconsideration of the denial of
an application for recognition, renewal of recognition, or
reinstatement of recognition no later than 10 business days after the
date of such decision.
    (b) A third-party auditor/certification body may seek
reconsideration of the denial of an application for direct
accreditation, renewal of direct accreditation, reinstatement of direct
accreditation, a request for a waiver of the conflict of interest
requirement in Sec.  1.650(b), or a waiver extension no later than 10
business days after the date of such decision.
    (c) A request to reconsider an application or waiver request under
paragraph (a) or (b) of this section must be signed by the requestor or
by an individual authorized to act on its behalf in submitting the
request for reconsideration. The request must be submitted in English
to the address specified in the notice of denial and must comply with
the procedures it describes.
    (d) After completing its review and evaluation of the request for
reconsideration, FDA will notify the requestor, in writing, of its
decision to grant the application or waiver request upon
reconsideration, or its decision to deny the application or waiver
request upon reconsideration.

Sec.  1.692  How do I request internal agency review of a denial of an
application or waiver request upon reconsideration?

    (a) No later than 10 business days after the date FDA issued a
denial of an application or waiver request upon reconsideration under
Sec.  1.691, the requestor may seek internal agency review of such
denial under Sec.  10.75(c)(1) of this chapter.
    (b) The request for internal agency review under paragraph (a) of
this section must be signed by the requestor or by an individual
authorized to act on its behalf in submitting the request for internal
review. The request must be submitted in English to the address
specified in the letter of denial upon reconsideration and must comply
with procedures it describes.
    (c) Under Sec.  10.75(d) of this chapter, internal agency review of
such denial must be based on the information in the administrative
file, which will include any supporting information submitted under
Sec.  1.691(c).
    (d) After completing the review and evaluation of the
administrative file, FDA will notify the requestor, electronically, of
its decision to overturn the denial and grant the application or waiver
request or to affirm the denial of the application or waiver request
upon reconsideration.
    (e) Affirmation by FDA of a denial of an application or waiver
request upon reconsideration constitutes final agency action under 5
U.S.C. 702.

Sec.  1.693  How do I request a regulatory hearing on a revocation of
recognition or withdrawal of accreditation?

    (a) Request for hearing on revocation. No later than 10 business
days after the date FDA issued a revocation of recognition of an
accreditation body under Sec.  1.634, the accreditation body or an
individual authorized to act on its behalf may submit a request for a
regulatory hearing on the revocation under part 16 of this chapter. The
written notice of revocation issued under Sec.  1.634 will contain all
of the elements required by Sec.  16.22 of this chapter and will
thereby constitute the notice of an opportunity for hearing under part
16 of this chapter.
    (b) Request for hearing on withdrawal. No later than 10 business
days after the date FDA issued a withdrawal of

accreditation of a third-party auditor/certification body under Sec.
1.664, the auditor/certification body or an individual authorized to
act on its behalf may submit a request for a regulatory hearing on the
withdrawal under part 16 of this chapter. The written notice of
withdrawal under Sec.  1.664 will contain all of the elements required
by Sec.  16.22 of this chapter and will thereby constitute the notice
of opportunity of hearing under part 16 of this chapter.
    (c) Submission of request for regulatory hearing. The request for a
regulatory hearing under paragraph (a) or (b) of this section must be
submitted with a written appeal that responds to the basis for the FDA
decision, as described in the written notice of revocation or
withdrawal, as appropriate, and includes any supporting information
upon which the requestor is relying. The request, appeal, and
supporting information must be submitted in English to the address
specified in the notice and must comply with the procedures it
describes.
    (d) Effect of submission of request on FDA decision. The submission
of a request for a regulatory hearing under paragraph (a) or (b) of
this section will not operate to delay or stay the effect of a decision
by FDA to revoke recognition of an accreditation body or to withdraw
accreditation of an auditor/certification body unless FDA determines
that a delay or a stay is in the public interest.
    (e) Presiding officer. The presiding officer for a regulatory
hearing for a revocation or withdrawal under this subpart will be
designated after a request for a regulatory hearing is submitted to
FDA.
    (f) Denial of a request for regulatory hearing. The presiding
officer may deny a request for regulatory hearing for a revocation or
withdrawal under Sec.  16.26(a) of this chapter.
    (g) Conduct of regulatory hearing. (1) If the presiding officer
grants a request for a regulatory hearing for a revocation or
withdrawal, the hearing will be held within 10 business days after the
date the request was filed or, if applicable, within a timeframe agreed
upon in writing by requestor, the presiding officer, and FDA.
    (2) The presiding officer may require that a regulatory hearing for
a revocation or withdrawal be completed within 1 business day, as
appropriate.
    (3) The presiding officer must conduct the regulatory hearing for
revocation or withdrawal under part 16 of this chapter, except that,
under Sec.  16.5 of this chapter, such procedures apply only to the
extent that the procedures are supplementary and do not conflict with
the procedures specified for regulatory hearings under this subpart.
Accordingly, the following requirements are inapplicable to regulatory
hearings under this subpart: The requirements of Sec.  16.22
(Initiation of a regulatory hearing); Sec.  16.24(e) (timing) and (f)
(contents of notice); Sec.  16.40 (Commissioner); Sec.  16.95(b)
(administrative decision and record for decision) and Sec.  16.119
(Reconsideration and stay of action) of this chapter.
    (4) A decision by the presiding officer to affirm the revocation of
recognition or the withdrawal of accreditation is considered a final
agency action under 5 U.S.C. 702.

Audits for Other Purposes

Sec.  1.698  May importers use reports of regulatory audits by
accredited auditors/certification bodies for purposes of subpart L of
this part?

    An importer, as defined in Sec.  1.500 of this part, may use a
regulatory audit of an eligible entity, documented in a regulatory
audit report, in meeting requirements for an onsite audit of a foreign
supplier under subpart L of this part.

PART 16--REGULATORY HEARING BEFORE THE FOOD AND DRUG ADMINISTRATION

0
3. The authority citation for 21 CFR part 16 continues to read as
follows:

    Authority: 15 U.S.C. 1451-1461; 21 U.S.C. 141-149, 321-394,
467f, 679, 821, 1034; 28 U.S.C. 2112; 42 U.S.C. 201-262, 263b, 364.

0
4. Section 16.1 is amended by numerically adding the following entry in
paragraph (b)(2) to read as follows:

Sec.  16.1  Scope.

* * * * *
    (b) * * *
    (2) * * *
    Sec. Sec.  1.634 and 1.664, relating to revocation of recognition
of an accreditation body and withdrawal of accreditation of auditors/
certification bodies that conduct food safety audits of eligible
entities in the food import supply chain and issue food and facility
certifications.
* * * * *

    Dated: July 23, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-17994 Filed 7-26-13; 8:45 am]
BILLING CODE 4160-01-P


[Federal Register Volume 79, Number 131 (Wednesday, July 9, 2014)]
[Notices]
[Pages 38887-38890]
[FR Doc No: 2014-16064]

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ENVIRONMENTAL PROTECTION AGENCY

[FRL-9913-55-OAR]

Protection of Stratospheric Ozone: Request for Methyl Bromide
Critical Use Exemption Applications for 2017

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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

SUMMARY: The Environmental Protection Agency is providing notice of the
process for submitting applications for critical use exemptions for
2017. Critical use exemptions are exceptions to the phaseout of
production and import of methyl bromide, a controlled class I ozone-
depleting substance. Critical use exemptions must be authorized by the
Parties to the Montreal Protocol on Substances that Deplete the Ozone
Layer and must be in accordance with the Clean Air Act. Applications
received in accordance with this notice will be considered as the basis
for submitting potential nominations for critical use exemptions to
future Meetings of the Parties to the Montreal Protocol. Critical use
exemptions allow production and import only in the year for which the
Parties authorize them. All entities interested in obtaining a critical
use exemption must provide EPA with technical and economic information
to support a ``critical use'' claim by the deadline specified in this
notice even if they have applied for an exemption in previous years.

DATES: Applications for critical use exemptions must be submitted to
EPA no later than September 30, 2014.

ADDRESSES: Applications for the methyl bromide critical use exemption
can also be submitted by U.S. mail to: U.S. Environmental Protection
Agency, Office of Air and Radiation, Stratospheric Protection Division,
Attention Methyl Bromide Team, Mail Code 6205M, 1200 Pennsylvania Ave.
NW., Washington, DC 20460.
    Confidentiality: Application materials that are confidential should
be submitted under separate cover and be clearly identified as
``confidential business information.'' Information covered by a claim
of business confidentiality will be treated in accordance with the
procedures for handling information claimed as confidential under 40
CFR part 2, subpart B, and will be disclosed only to the extent and by
means of the procedures set forth in that subpart. If no claim of
confidentiality accompanies the information when it is received by EPA,
the information may be made available to the public by EPA without
further notice to the company (40 CFR 2.203). EPA may place a copy of
Worksheet 6 in the public domain. Any information on Worksheet 6 shall
not be considered confidential and will not be treated as such by the
Agency.

FOR FURTHER INFORMATION CONTACT:
    General Information: U.S. EPA Stratospheric Ozone Information
Hotline, 1-800-296-1996; also www.epa.gov/ozone/mbr.
    Technical Information: Bill Chism, U.S. Environmental Protection
Agency, Office of Pesticide Programs (7503P), 1200 Pennsylvania Ave.
NW., Washington, DC 20460,<PHONE_NUMBER>. Email<EMAIL_ADDRESS>    Regulatory Information: Jeremy Arling, U.S. Environmental
Protection Agency, Stratospheric Protection Division (6205M), 1200
Pennsylvania Ave. NW., Washington, DC 20460,<PHONE_NUMBER>. EPA
encourages users to submit their applications electronically to
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Background on the Critical Use Exemption

    The Montreal Protocol on Substances that Deplete the Ozone Layer is
the international agreement aimed at reducing and eliminating the
production and consumption of stratospheric ozone-depleting substances.
Methyl bromide was added to the Protocol as an ozone-depleting
substance in 1992 through the Copenhagen Amendment.
    The Protocol provides that the Parties may exempt ``the level of
production or consumption that is necessary to satisfy uses agreed by
them to be critical uses'' (Art. 2H para 5). The Parties to the
Protocol included this language in the treaty's methyl bromide phaseout
provisions in recognition that alternatives might not be available by
2005 for certain uses of methyl bromide agreed by the Parties to be
``critical uses.''
    In their Ninth Meeting (1997), the Parties agreed to Decision IX/6,
setting forth the following criteria for a ``critical use''
determination and an exemption from the production and consumption
phaseout:
    (a) That a use of methyl bromide should qualify as ``critical''
only if the nominating Party determines that:
    (i) The specific use is critical because the lack of availability
of methyl bromide for that use would result in a significant market
disruption; and
    (ii) There are no technically and economically feasible
alternatives or substitutes available to the user that are acceptable
from the standpoint of environment and health and are suitable to the
crops and circumstances of the nomination.
    (b) That production and consumption, if any, of methyl bromide for
a critical use should be permitted only if:
    (i) All technically and economically feasible steps have been taken
to minimize the critical use and any associated emission of methyl
bromide;
    (ii) Methyl bromide is not available in sufficient quantity and
quality from existing stocks of banked or recycled methyl bromide, also
bearing in mind the developing countries' need for methyl bromide;
    (iii) It is demonstrated that an appropriate effort is being made
to evaluate, commercialize and secure national regulatory approval of
alternatives and substitutes, taking into consideration the
circumstances of the particular nomination. . . . Non-Article 5 Parties
[which includes the U.S.] must demonstrate that research programs are
in place to develop and deploy alternatives and substitutes. . . .
    In 1998, Congress amended the Clean Air Act to require EPA to
conform the U.S. phaseout schedule for methyl bromide to the provisions
of the Protocol and to allow EPA to provide a critical use exemption.
These amendments were codified in Section 604 of the Clean Air Act, 42
U.S.C. 7671c. Under EPA implementing regulations, the production and
consumption of methyl bromide was phased out as of January 1, 2005.
Section 604(d)(6), as added in 1998, allows EPA to exempt the
production and import of methyl bromide from the phaseout for critical
uses, to the extent consistent with the Montreal Protocol. EPA has
defined ``critical use'' at 40 CFR 82.3 based on the criteria in
Decision IX/6.
    EPA regulations at 40 CFR 82.4 prohibit the production and import
of methyl bromide in excess of the amount of unexpended critical use
allowances held by the producer or importer, unless authorized under a
separate exemption. Methyl bromide produced or imported by expending
critical use allowances may be used only for the appropriate category
of approved critical uses as listed in Appendix L to the regulations
(40 CFR 82.4(p)(2)). The use of methyl bromide that was produced or
imported through the expenditure of production

or consumption allowances prior to 2005, while not confined to critical
uses under EPA's phaseout regulations, is subject to the labeling
restrictions under FIFRA as specified in the product labeling.

II. Critical Use Nomination Process

    Entities requesting critical use exemptions should send a completed
application to EPA on the candidate use by September 30, 2014. Critical
use exemptions are valid for only one year and do not automatically
renew. All users desiring to obtain an exemption must apply to EPA
annually even if they have applied for critical uses in prior years.
Because of the potential for changes to registration status, costs, and
economic aspects of producing critical use crops and commodities,
applicants must fill out the application form completely.
    Upon receipt of applications, EPA will review the information and
work with other interested Federal agencies as required in section 604
of the Clean Air Act to determine whether the candidate use satisfies
Clean Air Act requirements, and whether it meets the critical use
criteria adopted by the Parties to the Montreal Protocol and warrants
nomination by the United States for an exemption.
    All Parties, including the United States, must transmit nominations
to the UNEP Ozone Secretariat by January 24, 2015, to be considered by
the Parties at their annual meeting at the end of 2015. The UNEP Ozone
Secretariat forwards nominations to the Montreal Protocol's Technical
and Economic Assessment Panel (TEAP) and the Methyl Bromide Technical
Options Committee (MBTOC). The MBTOC and the TEAP review the
nominations to determine whether they meet the criteria for a critical
use established by Decision IX/6, and to make recommendations to the
Parties for critical use exemptions. The Parties then consider those
recommendations at their annual meeting before making a final decision.
If the Parties determine that a specified use of methyl bromide is
critical and authorize an exemption from the Protocol's production and
consumption phaseout for 2017, EPA may then take domestic action to
allow the production and consumption to the extent consistent with the
Clean Air Act.

III. Information Required for Critical Use Application

    Entities interested in obtaining a critical use exemption must
complete the application form available at www.epa.gov/ozone/mbr/cueinfo.html. Applications requesting critical use allowances should
include information that U.S. Government agencies and the Parties to
the Protocol can use to evaluate the candidate use according to the
criteria in Decision IX/6 described above. Applications that fail to
include sufficient information may not be nominated.
    Specifically, applications should include the information requested
in the current version of the TEAP Handbook on Critical Use
Nominations. The handbook is available electronically at http://ozone.unep.org/Assessment_Panels/TEAP/Reports/MBTOC/Handbook%20CUN-version5-27Nov06.pdf. EPA requests that applications contain the
following information, as described in the handbook, in order for the
U.S. to provide sufficient information to the Montreal Protocol's
technical review bodies within the nomination:
     A clear statement on the specific circumstances of the
nomination which describe the critical need for methyl bromide and
quantity of methyl bromide requested;
     Data on the availability and technical and economic
feasibility of alternatives to the proposed methyl bromide use;
     A review of the comparative performance of methyl bromide
and alternatives including control of target pests in research and
commercial scale up studies; \1\
---------------------------------------------------------------------------

    \1\ Where an alternative is not registered for use in a
particular jurisdiction, growers in that jurisdiction need not
address the performance of that particular alternative.
---------------------------------------------------------------------------

     A description of all technically and economically feasible
steps taken by the applicant to minimize methyl bromide use and
emissions;
     Data on the use and availability of stockpiled methyl
bromide;
     A description of efforts made to test, register, and
commercially adopt alternatives;
     Plans for phase-out of critical uses of methyl bromide;
     The methodology used to provide economic comparisons.
    EPA's Web site (www.epa.gov/ozone/mbr/alts.html) contains a list of
available and potential alternatives. To support the assertion that a
specific use of methyl bromide meets the requirements of the critical
use exemption, applicants must demonstrate that none of the listed
alternatives are technically and economically feasible for that use. In
addition, applicants must describe research plans which includes the
pest(s), chemical(s), or management practice(s) they will be testing to
support their transition from methyl bromide.
    Since there is no formal end date for the CUE program, anyone
interested in obtaining a critical use exemption may apply. However,
the language and spirit of controls on ozone depleting substances under
the Montreal Protocol envisions a phaseout and for the critical use
exemption to be a ``temporary derogation'' from that phaseout. Over the
last decade, the research, registration, and adoption of alternatives
has led many sectors to transition from methyl bromide. The number of
sectors nominated has declined from seventeen for 2006 to two for 2016.
Below is information on how the agency evaluated specific uses in
considering nominations for critical uses for 2016, as well as specific
information needed for the U.S. to successfully defend future
nominations for critical uses.

Commodities Such as Dried Fruit and Nuts

    Data reviewed by EPA as part of the 2016 nomination process for
commodities such as dried fruit and nuts indicate that sulfuryl
fluoride is effective against key pests. The industry has mostly
converted to sulfuryl fluoride and no market disruption has occurred.
Rapid fumigation is not a critical condition for this sector and
therefore products can be treated with sulfuryl fluoride or phosphine
and be held for relatively long periods of time without a significant
economic impact.
    To support a nomination, applicants must address potential economic
losses due to pest pressures, changes in quality, changes in timing,
and any other economic implications for producers when converting to
alternatives. Alternatives for which such information is needed are:
Sulfuryl fluoride, propylene oxide (PPO), phosphine, and controlled
atmosphere/temperature treatment system. Applicants should include the
costs to retrofit equipment or design and construct new fumigation
chambers for these alternatives. For the economic assessment applicants
must provide: The amount of fumigant gas used (for both methyl bromide
and alternatives, which may include heat), price per pound of the
fumigant gas from the most recent use season, application rates,
differences in time required for fumigation, differences in labor
inputs (i.e., hours and wages) associated with alternatives, the amount
of commodity treated with each fumigant/treatment and the value of the
commodity being treated/produced. Applicants should also provide
information on changes in costs for any other practices or

equipment used (e.g., sanitation and IPM) that are not needed when
methyl bromide is used for fumigation, including information on the
size of fumigation chambers where methyl bromide is used, the percent
of commodity fumigated under tarps, the length of the harvest season,
peak of the harvest season and duration, and volume of commodity
treated daily at the harvest peak.
    Where applicable, also provide examples of specific customer
requests regarding pest infestation and examples of any phytosanitary
requirements of foreign markets (e.g., import requirements of other
countries) that may necessitate use of methyl bromide accompanied by
explanation of why the methyl bromide quarantine and preshipment (QPS)
exemption is not applicable for this purpose. Also include information
on what pest control practices organic producers are using for their
commodity.

Dried Cured Pork

    Applicants must list how many facilities have been fumigated with
methyl bromide over the last three years; the rate, volume, and target
concentration over time [CT] of methyl bromide at each location; volume
of each facility; number of fumigations per year; and the materials
from which the facility was constructed. It is important for this
sector to specify research plans into alternatives and alternative
practices that support the transition from methyl bromide, as well as
information on the technical and economic feasibility of using
recapture technologies. Given the low volume of usage requested by the
sector compared to the amount of remaining pre-phaseout inventory, it
will also be important for applicants to indicate efforts to secure and
use stockpiled methyl bromide.

Cucurbits, Eggplant, Pepper, and Tomato

    In reviewing data for the 2016 CUE nomination, EPA found that
although no single alternative is effective for all pest problems, a
review of multiple year data indicates that the alternatives in various
combinations provide control equal or superior to methyl bromide plus
chloropicrin. Several research studies show that the three way mixture
of 1,3-dichloropene plus chloropicrin plus metam sodium can effectively
suppress pathogens (P. capsici, F. oxysporum) and nematodes.
    To support a nomination, applicants must address potential changes
to yield, quality, and timing when converting to alternatives,
including: The mixture of 1,3-dichloropropene plus chloropicrin, the
University of Georgia three way mixture of 1,3-dichloropropene plus
chloropicrin plus metam (sodium or potassium) or allyl isothiocyanate
(DominusTM) used in place of metam, dimethyl disulfide
(DMDS), and any fumigationless system (if data are available).
Applications must address regulatory and economic implications for
growers and your region's production of these crops using these
alternatives, including the costs to retrofit equipment and the
differential impact of buffers for methyl bromide plus chloropicrin
compared to the alternatives. For the economic assessment applicants
must provide the following: Price per pound of fumigant gas used (both
methyl bromide and alternatives) from the most recent use season;
application rates; value of the crop being produced; differences in
labor inputs (i.e., hours and wages); and any differences in equipment
costs or time needed to operate equipment associated with alternatives.

Strawberry Fruit

    Based on EPA's review of information as part of the 2016 nomination
process, EPA believes alternatives are available as advances have been
made: (1) In safely applying 100% chloropicrin, (2) in strategies to
improve efficacy in applying 1,3-dichloropropene, and (3) in
transitioning from experimental to commercial use of non-chemical
tools, such as steam, anaerobic soil disinfestations, and substrate
production.
    To support a nomination, applicants must address potential changes
to yield, quality, and timing when converting to alternatives,
including: The mixture of 1,3-dichloropropene plus chloropicrin, the
University of Georgia three way mixture of 1,3-dichloropropene plus
chloropicrin plus metam (sodium or potassium) or allyl isothiocyanate
(DominusTM) used in place of metam in states other than
California, or dimethyl disulfide (DMDS), and any fumigationless system
(if data are available). Applications must address regulatory and
economic implications for growers and your region's production of these
crops using these alternatives, including the costs to retrofit
equipment and the differential impact of buffers for methyl bromide
plus chloropicrin compared to the alternatives. For the economic
assessment applicants must provide the following: Price per pound of
fumigant gas used (both methyl bromide and alternatives) from the most
recent use season; application rates; value of the crop being produced;
differences in labor inputs (i.e., hours and wages); and any
differences in equipment costs or time needed to operate equipment
associated with alternatives.

Orchard Replant

    EPA's review of data in the 2016 nomination process indicated that
while no single alternative is effective for all pest problems,
numerous field trials indicate alternatives to methyl bromide are
effective. Therefore, EPA concluded that transitioning to the
alternatives was feasible without substantial losses. Registered
alternatives are available for individual-hole treatments and soil
preparation procedures are available to enable effective treatment with
alternatives even in soils with high moisture content.
    To support a nomination, applicants must address potential changes
to yield, quality, and timing when converting to alternatives,
including: The mixture of 1,3-dichloropropene plus chloropicrin, the
University of Georgia three way mixture of 1,3-dichloropropene plus
chloropicrin plus metam (sodium or potassium), dimethyl disulfide
(DMDS), and steam. Applications must address regulatory and economic
implications for growers and your region's production of these crops
using these alternatives, including the costs to retrofit equipment and
the differential impact of buffers for methyl bromide plus chloropicrin
compared to the alternatives. For the economic assessment applicants
must provide the following: Price per pound of fumigant gas used (for
both methyl bromide and alternatives) from the most recent use season;
application rates; value of the crop being produced; differences in
labor inputs (i.e., hours and wages); and any differences in equipment
costs or time needed to operate equipment associated with alternatives.

Ornamentals

    In considering nominations for 2016, EPA found that while no single
alternative is effective for all pest problems, a review of multiple
year data indicates that the alternatives in various combinations
provide control equal or superior to methyl bromide plus chloropicrin.
Research demonstrates that 1,3-dichloropene plus chloropicrin, the
three way mixture of 1,3-dichloropene plus chloropicrin plus metam
sodium, and dimethyl disulfide plus chloropicrin all show excellent
results. To support a nomination, applicants must address potential
changes to yield, quality, and timing when converting to alternatives,
including: The mixture of 1,3-dichloropropene plus chloropicrin, the

University of Georgia three way mixture of 1,3-dichloropropene plus
chloropicrin plus metam (sodium or potassium) or allyl isothiocyanate
(DominusTM) used in place of metam, dimethyl disulfide
(DMDS), and steam. Applications must address regulatory and economic
implications for growers and your region's production of these crops
using these alternatives, including the costs to retrofit equipment and
the differential impact of buffers for methyl bromide plus chloropicrin
compared to the alternatives. For the economic assessment applicants
must provide the following: Price per pound of fumigant gas used (both
methyl bromide and alternatives) from the most recent use season;
application rates; value of the crop being produced; differences in
labor inputs (i.e., hours and wages); and any differences in equipment
costs or time needed to operate equipment associated with alternatives.

Nurseries

    In considering this sector in the 2016 nomination process, EPA
noted that a Special Local Need label allows Telone II to be used in
accordance with certification standards for propagative material.\2\ To
support a nomination, applicants must address potential changes to
yield, quality, and timing when converting to alternatives, including:
The mixture of 1,3-dichloropropene plus chloropicrin, the University of
Georgia three way mixture of 1,3-dichloropropene plus chloropicrin plus
metam (sodium or potassium) or allyl isothiocyanate
(DominusTM) used in place of metam in states other than
California, dimethyl disulfide (DMDS), and steam. Applications must
address regulatory and economic implications for growers and your
region's production of these crops using these alternatives, including
the costs to retrofit equipment and the differential impact of buffers
for methyl bromide plus chloropicrin compared to the alternatives. For
the economic assessment applicants must provide the following: Price
per pound of fumigant gas used (for both methyl bromide and
alternatives) from the most recent use season; application rates; value
of the crop being produced; differences in labor inputs (i.e., hours
and wages); and any differences in equipment costs or time needed to
operate equipment associated with alternatives.
---------------------------------------------------------------------------

    \2\ EPA also noted that growers can use a combination of methyl
bromide for quarantine situations and 1,3-D plus chloropicrin for
non-quarantine situations to meet certification requirements.
---------------------------------------------------------------------------

Golf Courses

    EPA has not found that a significant market disruption would occur
in the golf industry in the absence of methyl bromide. To support a
nomination, applicants must address potential changes to quality when
converting to alternatives, including: Basamid, chloropicrin, 1,3-
dichloropene, 1,3-dichloropene plus chloropicrin, metam sodium, or
allyl isothiocyanate (DominusTM), and steam. Non-fumigant
alternatives currently in use (e.g., additional pesticides,
fertilizers, different cultural practices, and increased management)
should also be described. Applications must address regulatory and
economic implications for growers using these alternatives, including
the costs to retrofit equipment and the differential impact of buffers
for methyl bromide compared to the alternatives. For the economic
assessment, applicants must provide the following: Price per pound of
fumigant gas used (both methyl bromide and alternatives) from the most
recent use season; application rates; economic impact for the golf
course from a transition to alternatives (e.g., downtime when
resurfacing, years between fumigations); differences in labor inputs
(i.e., hours and wages); and any differences in equipment costs or time
needed to operate equipment associated with alternatives. Supporting
evidence could be included that would demonstrate that alternatives
lead to more frequent resurfacing and therefore, greater adverse
economic impacts. Applicants should also address their efforts to
secure and use stockpiled methyl bromide.
    The Office of Management and Budget (OMB) has approved the
information collection requirements contained in this notice under the
provisions of the Paperwork Reduction Act, 44 U.S.C. 3501 et seq. and
has assigned OMB control number 2060-0482.

    Authority: 42 U.S.C. 7414, 7601, 7671-7671q.

    Dated: July 1, 2014.
Sarah Dunham,
Director, Office of Atmospheric Programs.
[FR Doc. 2014-16064 Filed 7-8-14; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 78, Number 67 (Monday, April 8, 2013)]
[Notices]
[Page 20911]
[FR Doc No: 2013-08066]

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

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Project No. 14484-000]

Archon Energy 1, Inc.; Notice of Preliminary Permit Application
Accepted for Filing and Soliciting Comments, Motions To Intervene, and
Competing Applications

    On January 25, 2013, the Archon Energy 1, Inc., filed an
application for a preliminary permit, pursuant to section 4(f) of the
Federal Power Act (FPA), proposing to study the feasibility of the
Kaweah River Drop 1 Hydroelectric Project (Kaweah River Drop 1 or
project) to be located on Kaweah River, near the city of Woodlake,
Tulare County, California. The sole purpose of a preliminary permit, if
issued, is to grant the permit holder priority to file a license
application during the permit term. A preliminary permit does not
authorize the permit holder to perform any land-disturbing activities
or otherwise enter upon lands or waters owned by others without the
owners' express permission.
    The proposed project has two installation option alternatives; an
in-stream method and a short diversion method. The in-stream option
would consist of the following: (1) A gated water intake canal; (2) a
70-foot by 55-foot by 35-foot turbine structure enclosing two in-stream
VLH turbine generators operating at 500 kilowatts kW; and (3)
appurtenant facilities. The short diversion method would consist of the
following: (1) a gated water intake canal; (2) a concrete trough
diversion channel approximately 30 feet wide and 150 feet in length;
(3) a 70-foot by 55-foot by 35-foot turbine structure enclosing four
screw turbine generators operating at 250 kW; and (4) appurtenant
facilities. The proposed project would have a total installed capacity
of 1 megawatt and generate an estimated average annual energy
production of 5,000 megawatt-hours by diverting existing stream flow
into the diversion canal.
    Applicant Contact: Mr. Paul Grist, Archon Energy 1, Inc., 101 E.
Kennedy Blvd., Suite 2800, Tampa, Florida 33602, phone:<PHONE_NUMBER>.
    FERC Contact: Corey Vezina; phone:<PHONE_NUMBER>, email:
<EMAIL_ADDRESS>    Deadline for filing comments, motions to intervene, competing
applications (without notices of intent), or notices of intent to file
competing applications: 60 days from the issuance of this notice.
Competing applications and notices of intent must meet the requirements
of 18 CFR 4.36. Comments, motions to intervene, notices of intent, and
competing applications may be filed electronically via the Internet.
See 18 CFR 385.2001(a)(1)(iii) and the instructions on the Commission's
Web site http://www.ferc.gov/docs-filing/efiling.asp. Commenters can
submit brief comments up to 6,000 characters, without prior
registration, using the eComment system at http://www.ferc.gov/docs-filing/ecomment.asp. You must include your name and contact information
at the end of your comments. For assistance, please contact FERC Online
Support at<EMAIL_ADDRESS>or toll free at 1-866-208-3676,
or for TTY,<PHONE_NUMBER>. Although the Commission strongly encourages
electronic filing, documents may also be paper-filed. To paper-file,
mail an original and five copies to: Kimberly D. Bose, Secretary,
Federal Energy Regulatory Commission, 888 First Street NE., Washington,
DC 20426.
    More information about this project, including a copy of the
application, can be viewed or printed on the ``eLibrary'' link of
Commission's Web site at http://www.ferc.gov/docs-filing/elibrary.asp.
Enter the docket number (P-14484) in the docket number field to access
the document. For assistance, contact FERC Online Support.

    Dated: April 2, 2013.
 Kimberly D. Bose,
 Secretary.
[FR Doc. 2013-08066 Filed 4-5-13; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register: August 24, 2006 (Volume 71, Number 164)]
[Notices]
[Page 50109-50110]
[DOCID:fr24au06-87]

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

SECURITIES AND EXCHANGE COMMISSION

Sunshine Act Meeting

    Notice is hereby given, pursuant to the provisions of the
Government in the Sunshine Act, Pub. L. 94-409, that the Securities and
Exchange Commission will hold the following meeting during the week of
August 28, 2006:
    A Closed Meeting will be held on Tuesday, August 29, 2006 at 10
a.m.
    Commissioners, Counsels to the Commissioners, the Secretary to the
Commission, and recording secretaries will attend the Closed Meeting.
Certain staff members who have an interest in the matters may also be
present.
    The General Counsel of the Commission, or his designee, has
certified that, in his opinion, one or more of the exemptions set forth
in 5 U.S.C. 552b(c)(3), (5), (7), (9)(B), (10) and 17 CFR 200.402(a)
(3), (5), (7), (9)(ii), and (10) permit consideration of the scheduled
matters at the Closed Meeting.
    Commissioner Casey, as duty officer, voted to consider the items
listed for the closed meeting in closed session.
    The subject matters of the Closed Meeting scheduled for Tuesday,
August 29, 2006 will be:

Formal orders of investigation;
Institution and settlement of injunctive actions;
Institution and settlement of administrative proceedings of an
enforcement nature;
An adjudicatory matter;
Requests for information in an investigative file;
Litigation matter; and
Other matters related to enforcement proceedings.

    At times, changes in Commission priorities require alterations in
the scheduling of meeting items.
    For further information and to ascertain what, if any, matters have
been added, deleted or postponed, please contact: The Office of the
Secretary at<PHONE_NUMBER>.

    Dated: August 22, 2006.
Nancy M. Morris,
Secretary.
[FR Doc. 06-7177 Filed 8-22-06; 3:54 pm]

BILLING CODE 8010-01-P


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Exposure 		Modeling Public Meeting (EMPM) Information and Products

Minutes of the December 17, 2002 Exposure Modeling Public Meeting

Minutes of the December 17, 2002 Exposure Modeling Public Meeting

Michael Barrett EFED EPA - Chair

On this Page

Attendees

Welcome and Introductions

Review of Old Action Items

Brief Updates

Major Topics

Next Meeting and Other News Items

Attendees

Name	Association

Alan Rose	Valent

Alex Clem	EFED OPP EPA

Andy Newcombe	Levine-Fricke

Betsy Behl	EFED OPP EPA

Cathleen Haperman	USDA/ARS

Claude Beigel	BASF

Dave Gustafson	Monsanto

David Jones	EFED OPP EPA

Dirk Young	EFED EPA OPP

Don Wauchope	USDA ARS

Elise D.G. McCoy	FMC

Faruque Khan	EFED OPP EPA

James Hetrick	EFED OPP EPA

Jim Breithaupt	EFED OPP EPA

Jim Lin	EFED OPP EPA

Joe Massey	MS State University

John Fisher	Bayer

John Jordan	EFED OPP EPA

Kevin Armbrust	MSU

Larry Burns	EPA ORD Athens

Marietta Echeverria	EFED OPP EPA

Mark Cheplick	Waterborne Environmental

Mark Corbin	EFED OPP EPA

Mark Russell	DuPont

Mark Seaton	EFED OPP EPA

Mark Shocken	Uniroyal

Marty Williams	Waterborne Environmental

Mary Nett	Water Quality Consulting

Michael Barrett	EFED EPA - Chair

Michael Winchell	Stone Environmental

Mike Kenna	U.S. Golf Association

Mohammed Ruhman 	EFED EPA/OPP

Norman Birchfield	EFED OPP EPA

Paul Hendley	Syngenta

Piyush Singh	DuPont

Qing Li Ma	ET&S

Ron Parker	EFED OPP EPA

Russell Jones	Bayer CropScience

Scott Jackson	BASF

Stuart Cohen	ET&S

Susan Alexander	Stone Environmental

Tammy Estes	Stone Environmental

Wenlin Chin	Syngenta

Also making a short appearance: Steven Bradbury, Director, EFED.

Top of page

Welcome and Introductions

Michael Barrett opened the meeting at 9:00 and welcomed attendees. The group recorded thanks to Dirk Young and Jim Carleton for serving as EPA co-chairs over the last year.  Michael Barrett and Jim Hetrick are the new EFED Water Tech Team co-chairs.  The last minutes of the EMWG meeting are available on OPP's environmental model web site:
www.epa.gov/oppefed1/models/water/emwg_top.htm

Top of page

Review of Old Action Items

All to visit the web site listed above to access the information, especially the   charter presented by Betsy Behl.   DONE

CropLife America to send EFED list of email addresses of users on the CLA EMWG list server.  DONE  Note: The server does not accept attachments.  Please send copies of files to Betsy Behl and Michael Barrett who will distribute 	them via direct mail.

EFED to finalize and release revised version of Prospective Ground Water Monitoring Study guidance.  IN PROGRESS - BETSY WILL UPDATE

EFED to post policy identifying model versions and scenarios currently used for
estimating environmental exposure to pesticides.  The policy has not yet been posted, but the OPP Web site has been updated.  EXAMS can be found at the following site:
http://www.epa.gov/ceampubl/swater/index.htm.  Larry Burns indicated that PRZM 3.12 will be posted on the Center for Exposure Assessment Modeling (CEAM) website around February 2003.

 http://www.epa.gov/ceampubl/gwater/index.htm

EFED will update EMWG with suggested goals for 2003 at December meeting.  BETSY TO DISCUSS.

EFED will post letter of positive attributes of models on the models Web site:

http://www.epa.gov/oppefed1/models/water/emwg_top.htm. DONE

EFED to consider participation in European Union "FOCUS" (tiered modeling 	assessment) groups.  Several EMWG members expressed that it would be good for EFED to attend.  Budget constraints may make it difficult for EFED to attend, but they will keep abreast of developments.  Workshop in U.S. is a possibility.  A similar initiative is under way in the Environmental Fate Tech Team.  Russell Jones to ensure that information goes to Betsy Behl, Faruque Khan, and Mark Corbin.

All to send copies of their presentations at the September 24, 2002 meeting to EFED for posting on the web.

EFED to resolve the issue of CN switching in PRZM via discussion with model
originators and current owners.  TO BE DISCUSSED

In response to FR Notice, industry will submit detailed comments to EFED on scenarios and an ACCESS database format file comparing all the specific scenario parameters. DONE.  Request for comments from Larry.

Interested parties should evaluate the leaching assessment prototype system (PLUS) available on the Waterborne Web site:
http://www.waterborne-env.com.

People are encouraged to review and discuss at the next meeting or via the list  server.  Industry is ready to participate with EFED on ground water development efforts.

Industry to supply hydrology data from small-scale runoff studies to EPA.  EPA will use these studies to investigate the relationship between curve number and soil moisture. The purpose of this exercise is to determine how to make PRZM run more efficiently.   Dirk Young indicated that industry has submitted three studies that have been analyzed.  The relationship between soil moisture and curve number is similar to previous investigations. EFED is also working with an Australian data set and is waiting for the USDA data.  Don Wauchope to send Dirk Young the 	USDA runoff data to support work on the curve number program.

EFED and ORD to correct the curve number documentation.  Larry will update PRZM documentation in the next version (3.12).

Ingrid Sunzenauer's presentation from the last EMWG meeting will be posted on the Web: http://www.epa.gov/oppefed1/ecorisk/index.htm.  DONE

EPA to consider adding the EXAMINER tool to the EXPRESS shell.  TO BE
DISCUSSED.

Top of page

Brief Updates

PRZM/EXAMS Model - Larry Burns

- reported that ORD has checked PRZM 3.12 beta and will be supporting EXPRESS which includes 3.12 beta, 3.12 final and the European version.  ORD has not yet fixed the PRZM code for field capacity and wilting point based estimations.  This problem was discussed at the September EMWG meeting.

Action Item: ORD to address coding problem for field capacity and wilting point in PRZM.

Rice Modeling

The rice model RICEWQ currently has four scenarios.  Jim Breithaupt believes that they
need to add other scenarios that accounts for differences in soils/climate.  EFED would also like to add other types of water bodies to simulate bayous, etc.  They have added a thermal crop growth model to predict growth stage.  This project is awaiting prioritization in the budget for funding.

WARP - Ron Parker

- described WARP and the mini-pilot monitoring study that is being conducted
at five sites around the country.  The purpose of this mini-pilot is to investigate the process for selecting sites, evaluate GIS databases to determine if they reflect what is happening, and evaluate the number of samples needed to capture peak concentrations for the sites.  Russ Jones, Jim Hetrick, HED staff, and two USGS scientists will be looking at the mini-pilot data.  They are looking at three specific approaches for calculating daily time streams from percentiles predicted by WARP: variography with conditional simulation (similar to krieging), a Markov chain approach, and a simulated PRZM-EXAMS daily time-step approach.  WARP inputs depend on watershed delineation.

 Oak Ridge National Laboratory is working on a tool to identify drinking water intakes
and surrounding catchments -- the QA/QC process is underway for 6,000 watersheds.  They
hope to have the tool available by Spring of this year.  The pesticide usage project is also associated with this project. Industry is also investigating the use of sales data to predict usage.  USGS is working with industry and OPP to develop mechanisms to predict usage at each intake.  The most sensitive factor is amount of pesticide used.  USGS is looking at USDA, industry and DOANE data.  They are currently focusing on flowing water and agricultural uses.

Action Item: Michael Barrett and Betsy Behl will invite Gail Thielin from the USGS NAWQA pesticide synthesis group to give a presentation on how they use usage data.

Turf Umbrella - Mary Nett (Water Quality Consulting)

- discussed the turf initiative and reported that they are moving ahead on several fronts.  There are now seven industry participants as well as USGA, Mississippi State University, Oklahoma State University, and University of Maryland involved in this pilot study.  They are looking at 10 years of golf course runoff data and validation of current runoff scenarios.  A protocol has been drafted for a field runoff study which is designed to be applicable to any U.S. location.  Mississippi State and University of Maryland turf farm will be part of this project.  They are standardizing the test lot scale (0.2 A - Oklahoma and Georgia plot size), grass species according to the region, sampling and application methods, optimizing turf grass growth based on USGA guidance.  They will use simulated rainfall and test chemicals will be selected and applied in conjunction with simulated events.

Action Item: Mary Nett to send Betsy Behl the draft protocol.  Betsy will transmit it to the Water Quality Technical Team.

Spray Drift Models - Norm Birchfield

- reported that the Spray Drift Task Force has responded to EFED's concerns.  EFED expects to issue a follow-up response before the next meeting.  EPA is still concerned about the problems associated with the license agreement.  Both ORD and OPP believe that AgDRIFT should have a disclaimer equivalent to the EPA models.  Licensing is not acceptable to ORD because they will use AgDRIFT in a number of other models that are publicly available.  They feel that the letter was a good start, but it is time for industry "to give themselves a gold star and move on."  The Forest Service Model is still a viable alternative to AgDRIFT, and EPA will need to make a decision soon on whether to use AgDRIFT or AgDISP.

Paul Hendley and Russell Jones spoke on behalf of the SDTF and the industry,
respectively.  They assured the group that there had been a lot of discussion within industry and the Task Force to reach agreement on the content of the letter that was issued.  They were also optimistic that they would find a way to address OPP's and ORD's concerns on the use of Ag DRIFT.

New Meteorological Files and Scenarios

Industry is concerned about the problems identified with some of the new scenarios that are now publicly available for comment.

Action Items: EFED to discuss these scenarios at the next EMWG meeting.  Anyone who wants a copy of industry's comments can request them from Paul Hendley.

PRZM Temperature Routine - Tammy Estes

- raised a question about the temperature routine in PRZM.  Currently, PRZM uses the Q10 approach for estimating change in degradation.  The soil temperature module appears to be very sensitive to the starting date for soil temperature, but does not appear to mimic rapid increases in temperature, such as spring warming.  Scott Jackson also said that it does not work.

Action Item: Larry Burns, Tammy Estes, Mark Cheplick, Wenlin Chen and others will discuss this issue off-line and report back at the next meeting.  These concerns could be put together and sent out to the list server for discussion.

Top of page

Major Topics

EFED Budget Priorities - Betsy Behl

- reported that the budget situation has been delayed with continuing resolutions and is under enormous constraints.  The only firm commitment for money and FTE's that can be made at this time is for direct pesticide regulatory issues.  Other additional programs that EFED is tending to support include programs that document and standardize procedures and models, increase consistency in risk assessment, and promote harmonization activities.  Because of the endangered species law suits and water issues, there is interest in supporting tools for permitting analyses at smaller scales.  Tools, such as the vulnerability tool, may be supported.

Industry commented that they were under similar strictures and that these funding pressures emphasize the importance of finding acceptable ways for cooperative action on key projects.

Action Item: Betsy Behl will discuss at next meeting.

European Union Modeling Issues - FOCUS - Russell Jones and Mark Russell

- provided an update on FOCUS and ground water and surface water scenarios.

Action Items:  Their presentations will be placed on the EFED Web site.

PGW Database

The group will discuss this issue at the next meeting since the request for comments went out a few days before the December meeting.

Action Item: Industry will submit written comments by January 31, 2003, and the issue will be discussed at the next EMWG meeting.

USDA/ARS and EPA/OPP/EFED Workshop - Don Wauchope

- reported on a three-day workshop that was held between USDA/ARS and OPP/EFED aimed at improving communications and establishing future inter-Agency links.  The group plans to issue a report on "Science Needs for Credible Mitigation."  The workshop included three breakout sessions: risk mitigation and agricultural practice, experimental study design, and modeling and risk assessment.  The attendees developed useful goals in each of these areas and four future research projects:

a searchable database of quantifiable mitigation technologies of known effects of mitigation on runoff and groundwater concentrations via the National Ag 	Library;

a model to aid in the design of the mitigation buffers;

an approach to quantitative spray drift mitigation; and

field studies to assess the effectiveness of agricultural mitigation 	measures.

Top of page

Next Meeting and Other News Items

The next EMWG meeting is scheduled for March 19, 2003.  Michael Barrett will
confirm this time via the list server ASAP.

The American Chemical Society soil dissipation workshop is now scheduled for the Fall
2003 ACS meeting.

Action Items

EFED to update group on progress with Prospective Ground Water Monitoring Study guidance at next meeting.

ORD to post PRZM 3.12 on CEAM site.

EFED will discuss 2003 goals and budget priorities at next meeting.

Russell Jones will send information on the EU Kinetics Group to EFED via Betsy Behl.

Don Wauchope will send Dirk Young the USDA runoff data to support work on the curve number program.

EMWG members are encouraged to try the EXAMINER tool for visualizing modeloutput data (via Paul Hendley or Waterborne).  EPA will consider adding the EXAMINER tool to the EXPRESS shell and discuss at the next meeting.

Interested members should evaluate the PLUS (a privately developed ground-water exposure assessment tool) alpha leaching code and discuss at the next meeting or via the list server.  The code is available on the Waterborne Web site:

http://www.waterborne-env.com.

EFED to resolve the issue of CN switching in PRZM via discussion with model originators and current owners.

PGW database issues to be discussed at next EMWG meeting; industry to submit written comments by January 31, 2003.

ORD to address coding problem for field capacity and wilting point in PRZM.

Betsy Behl and Michael Barrett will invite Gail Thielin from USGS to give a
presentation on how they use usage data.

EMWG to discuss public comments on PRZM EXAMS scenarios at next meeting.

Mary Nett to send Betsy Behl the draft protocol for the turf runoff field study.  Betsy will transmit the protocol to the Water Tech Team for review.

Larry Burns, Mark Cheplick, Tammy Estes, Wenlin Chen and others will discuss the temperature dependent PRZM code issues off-line and report back to the group.  An example of the concerns could also be sent out to the list server for discussion.

Mark Russell and Russell Jones to send copies of their presentations on European modeling to Betsy Behl for posting on the Models Web site.

Don Wauchope to send presentation to Betsy for posting on the Models Web site.

Michael Barrett to confirm the date of the next meeting via the list server 	ASAP.

The tentative date is March 19, 2003 at 9:00 a.m.

Top of page

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