(iii) Foreign supplier performance, including:
    (A) The foreign supplier's procedures, processes, and practices
related to the safety of the food;
    (B) Applicable FDA food safety regulations and information relevant
to the foreign supplier's compliance with those regulations, including
whether the foreign supplier is the subject of an FDA warning letter,
import alert, or other FDA compliance action related to food safety
(or, when applicable, the relevant laws and regulations of a country
whose food safety system FDA has officially recognized as comparable or
determined to be equivalent to that of the United States, and
information relevant to the supplier's compliance with those laws and
regulations); and
    (C) The foreign supplier's food safety history, including available
information about results from testing foods for hazards, audit results
relating to the safety of the food, and responsiveness of the foreign
supplier in correcting problems.
    (iv) Any other factors as appropriate and necessary, such as
storage and transportation practices.
    (2) You must document the evaluation you conduct under paragraph
(a)(1) of this section.
    (b) Approval of foreign suppliers. You must approve your foreign
suppliers on the basis of the evaluation that you conducted under
paragraph (a) of this section or that you review and assess under
paragraph (d) of this section, and document your approval.
    (c) Reevaluation of a foreign supplier's performance and the risk
posed by a food. (1) Except as specified

in paragraph (d) of this section, you must promptly reevaluate the
concerns associated with the factors in paragraph (a)(1) of this
section when you become aware of new information about these factors,
and the reevaluation must be documented. If you determine that the
concerns associated with importing a food from a foreign supplier have
changed, you must promptly determine (and document) whether it is
appropriate to continue to import the food from the foreign supplier
and whether the supplier verification activities conducted under Sec.
1.506 or Sec.  1.511(c) need to be changed.
    (2) If at the end of any 3-year period you have not reevaluated the
concerns associated with the factors in paragraph (a)(1) of this
section in accordance with paragraph (c)(1) of this section, you must
reevaluate those concerns and take other appropriate actions, if
necessary, in accordance with paragraph (c)(1). You must document your
reevaluation and any subsequent actions you take in accordance with
paragraph (c)(1).
    (d) Review of another entity's evaluation or reevaluation of a
foreign supplier's performance and the risk posed by a food. If an
entity other than the foreign supplier has, using a qualified
individual, performed the evaluation described in paragraph (a) of this
section or the reevaluation described in paragraph (c) of this section,
you may meet the requirements of the applicable paragraph by reviewing
and assessing the evaluation or reevaluation conducted by that entity.
You must document your review and assessment, including documenting
that the evaluation or reevaluation was conducted by a qualified
individual.
    (e) Inapplicability to certain circumstances. You are not required
to conduct an evaluation under this section or to conduct foreign
supplier verification activities under Sec.  1.506 if one of the
circumstances described in Sec.  1.507 applies to your importation of a
food and you are in compliance with that section.

Sec.  1.506  What foreign supplier verification and related activities
must I conduct?

    (a) Use of approved foreign suppliers. (1) You must establish and
follow written procedures to ensure that you import foods only from
foreign suppliers you have approved based on the evaluation conducted
under Sec.  1.505 (or, when necessary and appropriate, on a temporary
basis from unapproved foreign suppliers whose foods you subject to
adequate verification activities before importing the food). You must
document your use of these procedures.
    (2) You may rely on an entity other than your foreign supplier to
establish the procedures and perform and document the activities
required under paragraph (a)(1) of this section provided that you
review and assess that entity's documentation of the procedures and
activities, and you document your review and assessment.
    (b) Foreign supplier verification procedures. You must establish
and follow adequate written procedures for ensuring that appropriate
foreign supplier verification activities are conducted with respect to
the foods you import.
    (c) Requirement of supplier verification. The foreign supplier
verification activities must provide assurance that the hazards
requiring a control in the food you import have been significantly
minimized or prevented.
    (d) Determination of appropriate foreign supplier verification
activities--(1)(i) General. Except as provided in paragraphs (d)(2) and
(3) of this section, before importing a food from a foreign supplier,
you must determine and document which verification activity or
activities listed in paragraphs (d)(1)(ii)(A) through (D) of this
section, as well as the frequency with which the activity or activities
must be conducted, are needed to provide adequate assurances that the
food you obtain from the foreign supplier is produced in accordance
with paragraph (c) of this section. Verification activities must
address the entity or entities that are significantly minimizing or
preventing the hazards or verifying that the hazards have been
significantly minimized or prevented (e.g., when an entity other than
the grower of produce subject to part 112 of this chapter harvests or
packs the produce and significantly minimizes or prevents the hazard or
verifies that the hazard has been significantly minimized or prevented,
or when the foreign supplier's raw material supplier significantly
minimizes or prevents a hazard). The determination of appropriate
supplier verification activities must be based on the evaluation of the
food and foreign supplier conducted under Sec.  1.505.
    (ii) Appropriate verification activities. The following are
appropriate supplier verification activities:
    (A) Onsite audits as specified in paragraph (e)(1)(i) of this
section;
    (B) Sampling and testing of a food as specified in paragraph
(e)(1)(ii) of this section;
    (C) Review of the foreign supplier's relevant food safety records
as specified in paragraph (e)(1)(iii) of this section; and
    (D) Other appropriate supplier verification activities as specified
in paragraph (e)(1)(iv) of this section.
    (2) Verification activities for certain serious hazards. When a
hazard in a food will be controlled by the foreign supplier and is one
for which there is a reasonable probability that exposure to the hazard
will result in serious adverse health consequences or death to humans
or animals, you must conduct or obtain documentation of an onsite audit
of the foreign supplier before initially importing the food and at
least annually thereafter, unless you make an adequate written
determination that, instead of such initial and annual onsite auditing,
other supplier verification activities listed in paragraph (d)(1)(ii)
of this section and/or less frequent onsite auditing are appropriate to
provide adequate assurances that the foreign supplier is producing the
food in accordance with paragraph (c) of this section, based on the
determination made under Sec.  1.505.
    (3) Reliance on a determination by another entity. You may rely on
a determination of appropriate foreign supplier verification activities
in accordance with paragraph (d)(1) or (2) of this section made by an
entity other than the foreign supplier if you review and assess whether
the entity's determination regarding appropriate activities (including
the frequency with which such activities must be conducted) is
appropriate. You must document your review and assessment, including
documenting that the determination of appropriate verification
activities was made by a qualified individual.
    (e) Performance of foreign supplier verification activities--(1)
Verification activities. Except as provided in paragraph (e)(2) of this
section, based on the determination made in accordance with paragraph
(d) of this section, you must conduct (and document) or obtain
documentation of one or more of the supplier verification activities
listed in paragraphs (e)(1)(i) through (iv) of this section for each
foreign supplier before importing the food and periodically thereafter.
    (i) Onsite audit of the foreign supplier. (A) An onsite audit of a
foreign supplier must be performed by a qualified auditor.
    (B) If the food is subject to one or more FDA food safety
regulations, an onsite audit of the foreign supplier must consider such
regulations and include a review of the supplier's written food safety
plan, if any, and its implementation, for the hazard being controlled
(or, when applicable, an onsite audit may consider relevant laws

and regulations of a country whose food safety system FDA has
officially recognized as comparable or determined to be equivalent to
that of the United States).
    (C) If the onsite audit is conducted solely to meet the
requirements of paragraph (e) of this section by an audit agent of a
certification body that is accredited in accordance with subpart M of
this part, the audit is not subject to the requirements in that
subpart.
    (D) You must retain documentation of each onsite audit, including
the audit procedures, the dates the audit was conducted, the
conclusions of the audit, any corrective actions taken in response to
significant deficiencies identified during the audit, and documentation
that the audit was conducted by a qualified auditor.
    (E) The following inspection results may be substituted for an
onsite audit, provided that the inspection was conducted within 1 year
of the date by which the onsite audit would have been required to be
conducted:
    (1) The written results of an appropriate inspection of the foreign
supplier for compliance with applicable FDA food safety regulations
conducted by FDA, representatives of other Federal Agencies (such as
the USDA), or representatives of State, local, tribal, or territorial
agencies; or
    (2) The written results of an inspection of the foreign supplier by
the food safety authority of a country whose food safety system FDA has
officially recognized as comparable or determined to be equivalent to
that of the United States, provided that the food that is the subject
of the onsite audit is within the scope of the official recognition or
equivalence determination, and the foreign supplier is in, and under
the regulatory oversight of, such country.
    (ii) Sampling and testing of the food. You must retain
documentation of each sampling and testing of a food, including
identification of the food tested (including lot number, as
appropriate), the number of samples tested, the test(s) conducted
(including the analytical method(s) used), the date(s) on which the
test(s) were conducted and the date of the report of the testing, the
results of the testing, any corrective actions taken in response to
detection of hazards, information identifying the laboratory conducting
the testing, and documentation that the testing was conducted by a
qualified individual.
    (iii) Review of the foreign supplier's relevant food safety
records. You must retain documentation of each record review, including
the date(s) of review, the general nature of the records reviewed, the
conclusions of the review, any corrective actions taken in response to
significant deficiencies identified during the review, and
documentation that the review was conducted by a qualified individual.
    (iv) Other appropriate activity. (A) You may conduct (and document)
or obtain documentation of other supplier verification activities that
are appropriate based on foreign supplier performance and the risk
associated with the food.
    (B) You must retain documentation of each activity conducted in
accordance with paragraph (e)(1)(iv) of this section, including a
description of the activity, the date on which it was conducted, the
findings or results of the activity, any corrective actions taken in
response to significant deficiencies identified, and documentation that
the activity was conducted by a qualified individual.
    (2) Reliance upon performance of activities by other entities. (i)
Except as specified in paragraph (e)(2)(ii) of this section, you may
rely on supplier verification activities conducted in accordance with
paragraph (e)(1) of this section by another entity provided that you
review and assess the results of these activities in accordance with
paragraph (e)(3) of this section.
    (ii) You may not rely on the foreign supplier itself or employees
of the foreign supplier to perform supplier verification activities,
except with respect to sampling and testing of food in accordance with
paragraph (e)(1)(ii) of this section.
    (3) Review of results of verification activities. You must promptly
review and assess the results of the verification activities that you
conduct or obtain documentation of under paragraph (e)(1) of this
section, or that are conducted by other entities in accordance with
paragraph (e)(2) of this section. You must document your review and
assessment of the results of verification activities. If the results do
not provide adequate assurances that the hazards requiring a control in
the food you obtain from the foreign supplier have been significantly
minimized or prevented, you must take appropriate action in accordance
with Sec.  1.508(a). You are not required to retain documentation of
supplier verification activities conducted by other entities, provided
that you can obtain the documentation and make it available to FDA in
accordance with Sec.  1.510(b).
    (4) Independence of qualified individuals conducting verification
activities. There must not be any financial conflicts of interests that
influence the results of the verification activities set forth in
paragraph (e)(1) of this section, and payment must not be related to
the results of the activity.

Sec.  1.507  What requirements apply when I import a food that cannot
be consumed without the hazards being controlled or for which the
hazards are controlled after importation?

    (a) Circumstances. You are not required to conduct an evaluation of
a food and foreign supplier under Sec.  1.505 or supplier verification
activities under Sec.  1.506 when you identify a hazard requiring a
control (identified hazard) in a food and any of the following
circumstances apply:
    (1) You determine and document that the type of food (e.g., raw
agricultural commodities such as cocoa beans and coffee beans) could
not be consumed without application of an appropriate control;
    (2) You rely on your customer who is subject to the requirements
for hazard analysis and risk-based preventive controls in subpart C of
part 117 or subpart C of part 507 of this chapter to ensure that the
identified hazard will be significantly minimized or prevented and you:
    (i) Disclose in documents accompanying the food, in accordance with
the practice of the trade, that the food is ``not processed to control
[identified hazard]''; and
    (ii) Annually obtain from your customer written assurance, subject
to the requirements of paragraph (c) of this section, that the customer
has established and is following procedures (identified in the written
assurance) that will significantly minimize or prevent the identified
hazard;
    (3) You rely on your customer who is not subject to the
requirements for hazard analysis and risk-based preventive controls in
subpart C of part 117 or subpart C of part 507 of this chapter to
provide assurance it is manufacturing, processing, or preparing the
food in accordance with the applicable food safety requirements and
you:
    (i) Disclose in documents accompanying the food, in accordance with
the practice of the trade, that the food is ``not processed to control
[identified hazard]''; and
    (ii) Annually obtain from your customer written assurance that it
is manufacturing, processing, or preparing the food in accordance with
applicable food safety requirements;
    (4) You rely on your customer to provide assurance that the food
will be processed to control the identified hazard by an entity in the
distribution chain subsequent to the customer and you:

    (i) Disclose in documents accompanying the food, in accordance with
the practice of the trade, that the food is ``not processed to control
[identified hazard]''; and
    (ii) Annually obtain from your customer written assurance, subject
to the requirements of paragraph (c) of this section, that your
customer:
    (A) Will disclose in documents accompanying the food, in accordance
with the practice of the trade, that the food is ``not processed to
control [identified hazard]''; and
    (B) Will only sell the food to another entity that agrees, in
writing, it will:
    (1) Follow procedures (identified in a written assurance) that will
significantly minimize or prevent the identified hazard (if the entity
is subject to the requirements for hazard analysis and risk-based
preventive controls in subpart C of part 117 or subpart C of part 507
of this chapter) or manufacture, process, or prepare the food in
accordance with applicable food safety requirements (if the entity is
not subject to the requirements for hazard analysis and risk-based
preventive controls in subpart C of part 117 or subpart C of part 507);
or
    (2) Obtain a similar written assurance from the entity's customer,
subject to the requirements of paragraph (c) of this section, as in
paragraphs (a)(4)(ii)(A) and (B) of this section, as appropriate; or
    (5) You have established, documented, and implemented a system that
ensures control, at a subsequent distribution step, of the hazards in
the food you distribute and you document your implementation of that
system.
    (b) Written assurances. Any written assurances required under this
section must contain the following:
    (1) Effective date;
    (2) Printed names and signatures of authorized officials; and
    (3) The assurance specified in the applicable paragraph.
    (c) Provision of assurances. The customer or other subsequent
entity in the distribution chain for a food that provides a written
assurance under paragraph (a)(2), (3), or (4) of this section must act
consistently with the assurance and document its actions taken to
satisfy the written assurance.

Sec.  1.508  What corrective actions must I take under my FSVP?

    (a) You must promptly take appropriate corrective actions if you
determine that a foreign supplier of food you import does not produce
the food in compliance with processes and procedures that provide at
least the same level of public health protection as those required
under section 418 or 419 of the Federal Food, Drug, and Cosmetic Act,
if either is applicable, and the implementing regulations, or produces
food that is adulterated under section 402 or misbranded under section
403(w) (if applicable) of the Federal Food, Drug, and Cosmetic Act.
This determination could be based on a review of consumer, customer, or
other complaints related to food safety, the verification activities
conducted under Sec.  1.506 or Sec.  1.511(c), a reevaluation of the
risks posed by the food and the foreign supplier's performance
conducted under Sec.  1.505(c) or (d), or any other relevant
information you obtain. The appropriate corrective actions will depend
on the circumstances but could include discontinuing use of the foreign
supplier until the cause or causes of noncompliance, adulteration, or
misbranding have been adequately addressed. You must document any
corrective actions you take in accordance with this paragraph.
    (b) If you determine, by means other than the verification
activities conducted under Sec.  1.506 or Sec.  1.511(c) or a
reevaluation conducted under Sec.  1.505(c) or (d), that a foreign
supplier of food that you import does not produce food in compliance
with processes and procedures that provide at least the same level of
public health protection as those required under section 418 or 419 of
the Federal Food, Drug, and Cosmetic Act, if either is applicable, and
the implementing regulations, or produces food that is adulterated
under section 402 or misbranded under section 403(w) (if applicable) of
the Federal Food, Drug, and Cosmetic Act, you must promptly investigate
to determine whether your FSVP is adequate and, when appropriate,
modify your FSVP. You must document any investigations, corrective
actions, and changes to your FSVP that you undertake in accordance with
this paragraph.
    (c) This section does not limit your obligations with respect to
other laws enforced by FDA, such as those relating to product recalls.

Sec.  1.509  How must the importer be identified at entry?

    (a) You must ensure that, for each line entry of food product
offered for importation into the United States, your name, electronic
mail address, and unique facility identifier recognized as acceptable
by FDA, identifying you as the importer of the food, are provided
electronically when filing entry with U.S. Customs and Border
Protection.
    (b) Before an article of food is imported or offered for import
into the United States, the foreign owner or consignee of the food (if
there is no U.S. owner or consignee) must designate a U.S. agent or
representative as the importer of the food for the purposes of the
definition of ``importer'' in Sec.  1.500.

Sec.  1.510  How must I maintain records of my FSVP?

    (a) General requirements for records. (1) You must keep records as
original records, true copies (such as photocopies, pictures, scanned
copies, microfilm, microfiche, or other accurate reproductions of the
original records), or electronic records.
    (2) You must sign and date records concerning your FSVP upon
initial completion and upon any modification of the FSVP.
    (3) All records must be legible and stored to prevent deterioration
or loss.
    (b) Record availability. (1) You must make all records required
under this subpart available promptly to an authorized FDA
representative, upon request, for inspection and copying. Upon FDA
request, you must provide within a reasonable time an English
translation of records maintained in a language other than English.
    (2) Offsite storage of records, including records maintained by
other entities in accordance with Sec.  1.504, Sec.  1.505, or Sec.
1.506, is permitted if such records can be retrieved and provided
onsite within 24 hours of request for official review. Electronic
records are considered to be onsite if they are accessible from an
onsite location.
    (3) If requested in writing by FDA, you must send records to the
Agency electronically, or through another means that delivers the
records promptly, rather than making the records available for review
at your place of business.
    (c) Record retention. (1) Except as specified in paragraph (c)(2)
of this section, you must retain records referenced in this subpart
until at least 2 years after you created or obtained the records.
    (2) You must retain records that relate to your processes and
procedures, including the results of evaluations and determinations you
conduct, for at least 2 years after their use is discontinued (e.g.,
because you no longer import a particular food, you no longer use a
particular foreign supplier, you have reevaluated the risks associated
with a food and the foreign supplier, or you have changed your supplier
verification activities for a particular food and foreign supplier).
    (d) Electronic records. Records that are established or maintained
to satisfy the requirements of this subpart and that meet the
definition of electronic

records in Sec.  11.3(b)(6) of this chapter are exempt from the
requirements of part 11 of this chapter. Records that satisfy the
requirements of this subpart, but that also are required under other
applicable statutory provisions or regulations, remain subject to part
11.
    (e) Use of existing records. (1) You do not need to duplicate
existing records you have (e.g., records that you maintain to comply
with other Federal, State, or local regulations) if they contain all of
the information required by this subpart. You may supplement any such
existing records as necessary to include all of the information
required by this subpart.
    (2) You do not need to maintain the information required by this
subpart in one set of records. If existing records you have contain
some of the required information, you may maintain any new information
required by this subpart either separately or combined with the
existing records.
    (f) Public disclosure. Records obtained by FDA in accordance with
this subpart are subject to the disclosure requirements under part 20
of this chapter.

Sec.  1.511  What FSVP must I have if I am importing a food subject to
certain dietary supplement current good manufacturing practice
regulations?

    (a) Importers subject to certain dietary supplement current good
manufacturing regulations. If you are required to establish
specifications under Sec.  111.70(b) or (d) of this chapter with
respect to a food that is a dietary supplement or dietary supplement
component you import for further manufacturing, processing, or
packaging as a dietary supplement, and you are in compliance with the
requirements in Sec. Sec.  111.73 and 111.75 of this chapter applicable
to determining whether the specifications you established are met for
such food, then for that food you must comply with the requirements in
Sec. Sec.  1.503 and 1.509, but you are not required to comply with the
requirements in Sec.  1.502, Sec. Sec.  1.504 through 1.508, or Sec.
1.510. This requirement does not limit your obligations with respect to
part 111 of this chapter or any other laws enforced by FDA.
    (b) Importers whose customer is subject to certain dietary
supplement current good manufacturing practice regulations. If your
customer is required to establish specifications under Sec.  111.70(b)
or (d) of this chapter with respect to a food that is a dietary
supplement or dietary supplement component you import for further
manufacturing, processing, or packaging as a dietary supplement, your
customer is in compliance with the requirements of Sec. Sec.  111.73
and 111.75 of this chapter applicable to determining whether the
specifications it established are met for such food, and you annually
obtain from your customer written assurance that it is in compliance
with those requirements, then for that food you must comply with the
requirements in Sec. Sec.  1.503, 1.509, and 1.510, but you are not
required to comply with the requirements in Sec.  1.502 or Sec. Sec.
1.504 through 1.508.
    (c) Other importers of dietary supplements--(1) General. If the
food you import is a dietary supplement and neither paragraph (a) or
(b) of this section is applicable, you must comply with paragraph (c)
of this section and the requirements in Sec. Sec.  1.503,
1.505(a)(1)(ii) through (iv), (a)(2), and (b) through (d), and 1.508
through 1.510, but you are not required to comply with the requirements
in Sec. Sec.  1.504, 1.505(a)(1)(i), 1.506, and 1.507. This requirement
does not limit your obligations with respect to part 111 of this
chapter or any other laws enforced by FDA.
    (2) Use of approved foreign suppliers. (i) You must establish and
follow written procedures to ensure that you import foods only from
foreign suppliers that you have approved based on the evaluation
conducted under Sec.  1.505 (or, when necessary and appropriate, on a
temporary basis from unapproved foreign suppliers whose foods you
subject to adequate verification activities before importing the food).
You must document your use of these procedures.
    (ii) You may rely on an entity other than the foreign supplier to
establish the procedures and perform and document the activities
required under paragraph (c)(2)(i) of this section provided that you
review and assess that entity's documentation of the procedures and
activities, and you document your review and assessment.
    (3) Foreign supplier verification procedures. You must establish
and follow adequate written procedures for ensuring that appropriate
foreign supplier verification activities are conducted with respect to
the foods you import.
    (4) Determination of appropriate foreign supplier verification
activities--(i) General. Except as provided in paragraph (c)(4)(iii) of
this section, before importing a dietary supplement from a foreign
supplier, you must determine and document which verification activity
or activities listed in paragraphs (c)(4)(ii)(A) through (D) of this
section, as well as the frequency with which the activity or activities
must be conducted, are needed to provide adequate assurances that the
foreign supplier is producing the dietary supplement in accordance with
processes and procedures that provide the same level of public health
protection as those required under part 111 of this chapter. This
determination must be based on the evaluation conducted under Sec.
1.505.
    (ii) Appropriate verification activities. The following are
appropriate supplier verification activities:
    (A) Onsite audits as specified in paragraph (c)(5)(i)(A) of this
section;
    (B) Sampling and testing of a food as specified in paragraph
(c)(5)(i)(B) of this section;
    (C) Review of the foreign supplier's relevant food safety records
as specified in paragraph (c)(5)(i)(C) of this section; and
    (D) Other appropriate supplier verification activities as specified
in paragraph (c)(5)(i)(D) of this section.
    (iii) Reliance upon determination by other entity. You may rely on
a determination of appropriate foreign supplier verification activities
in accordance with paragraph (c)(4)(i) of this section made by an
entity other than the foreign supplier if you review and assess whether
the entity's determination regarding appropriate activities (including
the frequency with which such activities must be conducted) is
appropriate based on the evaluation conducted in accordance with Sec.
1.505. You must document your review and assessment, including
documenting that the determination of appropriate verification
activities was made by a qualified individual.
    (5) Performance of foreign supplier verification activities. (i)
Except as provided in paragraph (c)(5)(ii) of this section, for each
dietary supplement you import under paragraph (c) of this section, you
must conduct (and document) or obtain documentation of one or more of
the verification activities listed in paragraphs (c)(5)(i)(A) through
(D) of this section before importing the dietary supplement and
periodically thereafter.
    (A) Onsite auditing. You conduct (and document) or obtain
documentation of a periodic onsite audit of your foreign supplier.
    (1) An onsite audit of a foreign supplier must be performed by a
qualified auditor.
    (2) The onsite audit must consider the applicable requirements of
part 111 of this chapter and include a review of the foreign supplier's
written food safety plan, if any, and its implementation (or, when
applicable, an onsite audit may

consider relevant laws and regulations of a country whose food safety
system FDA has officially recognized as comparable or determined to be
equivalent to that of the United States).
    (3) If the onsite audit is conducted solely to meet the
requirements of paragraph (c)(5) of this section by an audit agent of a
certification body that is accredited in accordance with subpart M of
this part, the audit is not subject to the requirements in that
subpart.
    (4) You must retain documentation of each onsite audit, including
the audit procedures, the dates the audit was conducted, the
conclusions of the audit, any corrective actions taken in response to
significant deficiencies identified during the audit, and documentation
that the audit was conducted by a qualified auditor.
    (5) The following inspection results may be substituted for an
onsite audit, provided that the inspection was conducted within 1 year
of the date by which the onsite audit would have been required to be
conducted:
    (i) The written results of appropriate inspection of the foreign
supplier for compliance with the applicable requirements in part 111 of
this chapter conducted by FDA, representatives of other Federal
Agencies (such as the USDA), or representatives of State, local,
tribal, or territorial agencies; or
    (ii) The written results of an inspection by the food safety
authority of a country whose food safety system FDA has officially
recognized as comparable or determined to be equivalent to that of the
United States, provided that the food that is the subject of the onsite
audit is within the scope of the official recognition or equivalence
determination, and the foreign supplier is in, and under the regulatory
oversight of, such country.
    (B) Sampling and testing of the food. You must retain documentation
of each sampling and testing of a dietary supplement, including
identification of the food tested (including lot number, as
appropriate), the number of samples tested, the test(s) conducted
(including the analytical method(s) used), the date(s) on which the
test(s) were conducted and the date of the report of the testing, the
results of the testing, any corrective actions taken in response to
detection of hazards, information identifying the laboratory conducting
the testing, and documentation that the testing was conducted by a
qualified individual.
    (C) Review of the foreign supplier's food safety records. You must
retain documentation of each record review, including the date(s) of
review, the general nature of the records reviewed, the conclusions of
the review, any corrective actions taken in response to significant
deficiencies identified during the review, and documentation that the
review was conducted by a qualified individual.
    (D) Other appropriate activity. (1) You may conduct (and document)
or obtain documentation of other supplier verification activities that
are appropriate based on foreign supplier performance and the risk
associated with the food.
    (2) You must retain documentation of each activity conducted in
accordance with paragraph (c)(5)(i)(D)(1) of this section, including a
description of the activity, the date on which it was conducted, the
findings or results of the activity, any corrective actions taken in
response to significant deficiencies identified, and documentation that
the activity was conducted by a qualified individual.
    (ii) Reliance upon performance of activities by other entities. (A)
Except as specified in paragraph (c)(5)(ii)(B) of this section, you may
rely on supplier verification activities conducted in accordance with
paragraph (c)(5)(i) by another entity provided that you review and
assess the results of these activities in accordance with paragraph
(c)(5)(iii) of this section.
    (B) You may not rely on the foreign supplier or employees of the
foreign supplier to perform supplier verification activities, except
with respect to sampling and testing of food in accordance with
paragraph (c)(5)(i)(B) of this section.
    (iii) Review of results of verification activities. You must
promptly review and assess the results of the verification activities
that you conduct or obtain documentation of under paragraph (c)(5)(i)
of this section, or that are conducted by other entities in accordance
with paragraph (c)(5)(ii) of this section. You must document your
review and assessment of the results of verification activities. If the
results show that the foreign supplier is not producing the dietary
supplement in accordance with processes and procedures that provide the
same level of public health protection as those required under part 111
of this chapter, you must take appropriate action in accordance with
Sec.  1.508(a). You are not required to retain documentation of
supplier verification activities conducted by other entities, provided
that you can obtain the documentation and make it available to FDA in
accordance with Sec.  1.510(b).
    (iv) Independence of qualified individuals conducting verification
activities. There must not be any financial conflicts of interest that
influence the results of the verification activities set forth in
paragraph (c)(5)(i) of this section, and payment must not be related to
the results of the activity.

Sec.  1.512  What FSVP may I have if I am a very small importer or I am
importing certain food from certain small foreign suppliers?

    (a) Eligibility. This section applies only if:
    (1) You are a very small importer; or
    (2) You are importing certain food from certain small foreign
suppliers as follows:
    (i) The foreign supplier is a qualified facility as defined by
Sec.  117.3 or Sec.  507.3 of this chapter;
    (ii) You are importing produce from a foreign supplier that is a
farm that grows produce and is not a covered farm under part 112 of
this chapter in accordance with Sec.  112.4(a) of this chapter, or in
accordance with Sec. Sec.  112.4(b) and 112.5 of this chapter; or
    (iii) You are importing shell eggs from a foreign supplier that is
not subject to the requirements of part 118 of this chapter because it
has fewer than 3,000 laying hens.
    (b) Applicable requirements--(1) Documentation of eligibility--(i)
Very small importer status. (A) If you are a very small importer and
you choose to comply with the requirements in this section, you must
document that you meet the definition of very small importer in Sec.
1.500 with respect to human food and/or animal food before initially
importing food as a very small importer and thereafter on an annual
basis by December 31 of each calendar year.
    (B) For the purpose of determining whether you satisfy the
definition of very small importer with respect to human food and/or
animal food for a given calendar year, the relevant 3-year period of
sales (and U.S. market value of human or animal food, as appropriate)
is the period ending 1 year before the calendar year for which you
intend to import food as a very small importer. The baseline year for
calculating the adjustment for inflation is 2011. If you conduct any
food sales in currency other than U.S. dollars, you must use the
relevant currency exchange rate in effect on December 31 of the year in
which sales occurred to calculate the value of these sales.
    (ii) Small foreign supplier status. If you are a importing food
from a small foreign supplier as specified in paragraph (a)(2) of this
section and you choose to comply with the requirements in this section,
you must obtain written assurance that your foreign supplier

meets the criteria in paragraph (a)(2)(i), (ii), or (iii) of this
section before first approving the supplier for an applicable calendar
year and thereafter on an annual basis by December 31 of each calendar
year, for the following calendar year.
    (2) Additional requirements. If this section applies and you choose
to comply with the requirements in paragraph (b) of this section, you
also are required to comply with the requirements in Sec. Sec.  1.502,
1.503, and 1.509, but you are not required to comply with the
requirements in Sec. Sec.  1.504 through 1.508 or Sec.  1.510.
    (3) Foreign supplier verification activities. (i) If you are a very
small importer, for each food you import, you must obtain written
assurance, before importing the food and at least every 2 years
thereafter, that your foreign supplier is producing the food in
compliance with processes and procedures that provide at least the same
level of public health protection as those required under section 418
or 419 of the Federal Food, Drug, and Cosmetic Act, if either is
applicable, and the implementing regulations, and is producing the food
in compliance with sections 402 and 403(w) (if applicable) of the
Federal Food, Drug, and Cosmetic Act.
    (ii) If your foreign supplier is a qualified facility as defined by
Sec.  117.3 or Sec.  507.3 of this chapter and you choose to comply
with the requirements in this section, you must obtain written
assurance before importing the food and at least every 2 years
thereafter that the foreign supplier is producing the food in
compliance with applicable FDA food safety regulations (or, when
applicable, the relevant laws and regulations of a country whose food
safety system FDA has officially recognized as comparable or determined
to be equivalent to that of the United States). The written assurance
must include either:
    (A) A brief description of the preventive controls that the
supplier is implementing to control the applicable hazard in the food;
or
    (B) A statement that the supplier is in compliance with State,
local, county, tribal, or other applicable non-Federal food safety law,
including relevant laws and regulations of foreign countries.
    (iii) If your foreign supplier is a farm that grows produce and is
not a covered farm under part 112 of this chapter in accordance with
Sec.  112.4(a) of this chapter, or in accordance with Sec. Sec.
112.4(b) and 112.5 of this chapter, and you choose to comply with the
requirements in this section, you must obtain written assurance before
importing the produce and at least every 2 years thereafter that the
farm acknowledges that its food is subject to section 402 of the
Federal Food, Drug, and Cosmetic Act (or, when applicable, that its
food is subject to relevant laws and regulations of a country whose
food safety system FDA has officially recognized as comparable or
determined to be equivalent to that of the United States).
    (iv) If your foreign supplier is a shell egg producer that is not
subject to the requirements of part 118 of this chapter because it has
fewer than 3,000 laying hens and you choose to comply with the
requirements in this section, you must obtain written assurance before
importing the shell eggs and at least every 2 years thereafter that the
shell egg producer acknowledges that its food is subject to section 402
of the Federal Food, Drug, and Cosmetic Act (or, when applicable, that
its food is subject to relevant laws and regulations of a country whose
food safety system FDA has officially recognized as comparable or
determined to be equivalent to that of the United States) .
    (4) Corrective actions. You must promptly take appropriate
corrective actions if you determine that a foreign supplier of food you
import does not produce the food consistent with the assurance provided
in accordance with Sec.  1.512(b)(3)(i) through (iv). The appropriate
corrective actions will depend on the circumstances but could include
discontinuing use of the foreign supplier until the cause or causes of
noncompliance, adulteration, or misbranding have been adequately
addressed. You must document any corrective actions you take in
accordance with this paragraph (b)(4). This paragraph (b)(4) does not
limit your obligations with respect to other laws enforced by FDA, such
as those relating to product recalls.
    (5) Records--(i) General requirements for records. (A) You must
keep records as original records, true copies (such as photocopies,
pictures, scanned copies, microfilm, microfiche, or other accurate
reproductions of the original records), or electronic records.
    (B) You must sign and date records concerning your FSVP upon
initial completion and upon any modification of the FSVP.
    (C) All records must be legible and stored to prevent deterioration
or loss.
    (ii) Availability. (A) You must make all records required under
this subpart available promptly to an authorized FDA representative,
upon request, for inspection and copying. Upon FDA request, you must
provide within a reasonable time an English translation of records
maintained in a language other than English.
    (B) Offsite storage of records, including records retained by other
entities in accordance with paragraph (c) of this section, is permitted
if such records can be retrieved and provided onsite within 24 hours of
request for official review. Electronic records are considered to be
onsite if they are accessible from an onsite location.
    (C) If requested in writing by FDA, you must send records to the
Agency electronically or through another means that delivers the
records promptly, rather than making the records available for review
at your place of business.
    (iii) Record retention. (A) Except as specified in paragraph
(b)(5)(iii)(B) or (C) of this section, you must retain records required
under this subpart for a period of at least 2 years after you created
or obtained the records.
    (B) If you are subject to paragraph (c) of this section, you must
retain records that relate to your processes and procedures, including
the results of evaluations of foreign suppliers and procedures to
ensure the use of approved suppliers, for at least 2 years after their
use is discontinued (e.g., because you have reevaluated a foreign
supplier's compliance history or changed your procedures to ensure the
use of approved suppliers).
    (C) You must retain for at least 3 years records that you rely on
during the 3-year period preceding the applicable calendar year to
support your status as a very small importer.
    (iv) Electronic records. Records that are established or maintained
to satisfy the requirements of this subpart and that meet the
definition of electronic records in Sec.  11.3(b)(6) of this chapter
are exempt from the requirements of part 11 of this chapter. Records
that satisfy the requirements of this part, but that also are required
under other applicable statutory provisions or regulations, remain
subject to part 11.
    (v) Use of existing records. (A) You do not need to duplicate
existing records you have (e.g., records that you maintain to comply
with other Federal, State, or local regulations) if they contain all of
the information required by this subpart. You may supplement any such
existing records as necessary to include all of the information
required by this subpart.
    (B) You do not need to maintain the information required by this
subpart in one set of records. If existing records you have contain
some of the required information, you may maintain any new information
required by this subpart either separately or combined with the
existing records.

    (vi) Public disclosure. Records obtained by FDA in accordance with
this subpart are subject to the disclosure requirements under part 20
of this chapter.
    (c) Requirements for importers of food from certain small foreign
suppliers. The following additional requirements apply if you are
importing food from certain small foreign suppliers as specified in
paragraph (a)(2) of this section and you are not a very small importer:
    (1) Evaluation of foreign supplier compliance history--(i) Initial
evaluation. In approving your foreign suppliers, you must evaluate the
applicable FDA food safety regulations and information relevant to the
foreign supplier's compliance with those regulations, including whether
the foreign supplier is the subject of an FDA warning letter, import
alert, or other FDA compliance action related to food safety, and
document the evaluation. You may also consider other factors relevant
to a foreign supplier's performance, including those specified in Sec.
1.505(a)(1)(iii)(A) and (C).
    (ii) Reevaluation of foreign supplier compliance history. (A)
Except as specified in paragraph (c)(1)(iii) of this section, you must
promptly reevaluate the concerns associated with the foreign supplier's
compliance history when you become aware of new information about the
matters in paragraph (c)(1)(i) of this section, and the reevaluation
must be documented. If you determine that the concerns associated with
importing a food from a foreign supplier have changed, you must
promptly determine (and document) whether it is appropriate to continue
to import the food from the foreign supplier.
    (B) If at the end of any 3-year period you have not reevaluated the
concerns associated with the foreign supplier's compliance history in
accordance with paragraph (c)(1)(ii)(A) of this section, you must
reevaluate those concerns and take other appropriate actions, if
necessary, in accordance with paragraph (c)(1)(ii)(A). You must
document your reevaluation and any subsequent actions you take in
accordance with paragraph (c)(1)(ii)(A).
    (iii) Review of another entity's evaluation or reevaluation of
foreign supplier compliance history. If an entity other than the
foreign supplier has, using a qualified individual, performed the
evaluation described in paragraph (c)(1)(i) of this section or the
reevaluation described in paragraph (c)(1)(ii), you may meet the
requirements of the applicable paragraph by reviewing and assessing the
evaluation or reevaluation conducted by that entity. You must document
your review and assessment, including documenting that the evaluation
or reevaluation was conducted by a qualified individual.
    (2) Approval of foreign supplier. You must approve your foreign
suppliers on the basis of the evaluation you conducted under paragraph
(c)(1)(i) of this section or that you review and assess under paragraph
(c)(1)(iii) of this section, and document your approval.
    (3) Use of approved foreign suppliers. (i) You must establish and
follow written procedures to ensure that you import foods only from
foreign suppliers you have approved based on the evaluation conducted
under paragraph (c)(1)(i) of this section (or, when necessary and
appropriate, on a temporary basis from unapproved foreign suppliers
whose foods you subject to adequate verification activities before
importing the food). You must document your use of these procedures.
    (ii) You may rely on an entity other than the foreign supplier to
establish the procedures and perform and document the activities
required under paragraph (c)(3)(i) of this section provided that you
review and assess that entity's documentation of the procedures and
activities, and you document your review and assessment.

Sec.  1.513  What FSVP may I have if I am importing certain food from a
country with an officially recognized or equivalent food safety system?

    (a) General. (1) If you meet the conditions and requirements of
paragraph (b) of this section for a food of the type specified in
paragraph (a)(2) of this section that you are importing, then you are
not required to comply with the requirements in Sec. Sec.  1.504
through 1.508. You would still be required to comply with the
requirements in Sec. Sec.  1.503, 1.509, and 1.510.
    (2) This section applies to food that is not intended for further
manufacturing/processing, including packaged food products and raw
agricultural commodities that will not be commercially processed
further before consumption.
    (b) Conditions and requirements. (1) Before importing a food from
the foreign supplier and annually thereafter, you must document that
the foreign supplier is in, and under the regulatory oversight of, a
country whose food safety system FDA has officially recognized as
comparable or determined to be equivalent to that of the United States,
and that the food is within the scope of that official recognition or
equivalency determination.
    (2) Before importing a food from the foreign supplier, you must
determine and document whether the foreign supplier of the food is in
good compliance standing with the food safety authority of the country
in which the foreign supplier is located. You must continue to monitor
whether the foreign supplier is in good compliance standing and
promptly review any information obtained. If the information indicates
that food safety hazards associated with the food are not being
significantly minimized or prevented, you must take prompt corrective
action. The appropriate corrective action will depend on the
circumstances but could include discontinuing use of the foreign
supplier. You must document any corrective actions that you undertake
in accordance with this paragraph (b)(2).

Sec.  1.514  What are some consequences of failing to comply with the
requirements of this subpart?

    (a) Refusal of admission. An article of food is subject to refusal
of admission under section 801(a)(3) of the Federal Food, Drug, and
Cosmetic Act if it appears that the importer of that food fails to
comply with this subpart with respect to that food. If there is no U.S.
owner or consignee of an article of food at the time the food is
offered for entry into the United States, the article of food may not
be imported into the United States unless the foreign owner or
consignee has appropriately designated a U.S. agent or representative
as the importer in accordance with Sec.  1.500.
    (b) Prohibited act. The importation or offering for importation
into the United States of an article of food without the importer
having an FSVP that meets the requirements of section 805 of the
Federal Food, Drug, and Cosmetic Act, including the requirements of
this subpart, is prohibited under section 301(zz) of the Federal Food,
Drug, and Cosmetic Act.

PART 11--ELECTRONIC RECORDS; ELECTRONIC SIGNATURES

0
3. The authority citation for 21 CFR part 11 continues to read as
follows:

    Authority: 21 U.S.C. 321-393; 42 U.S.C. 262.

0
4. In Sec.  11.1, add and reserve paragraph (h) and (k) and add
paragraph (l) to read as follows:

Sec.  11.1  Scope.

* * * * *
    (l) This part does not apply to records required to be established
or maintained by subpart L of part 1 of this chapter. Records that
satisfy the requirements of subpart L of part 1 of this chapter, but
that also are required under other applicable statutory provisions or
regulations, remain subject to this part.

PART 111--CURRENT GOOD MANUFACTURING PRACTICE IN MANUFACTURING,
PACKAGING, LABELING, OR HOLDING OPERATIONS FOR DIETARY SUPPLEMENTS

0
5. The authority citation for 21 CFR part 111 continues to read as
follows:

    Authority: 21 U.S.C. 321, 342, 343, 371, 374, 381, 393; 42
U.S.C. 264.

0
6. In Sec.  111.5, add a sentence after the existing sentence to read
as follows:

Sec.  111.5  Do other statutory provisions and regulations apply?

    * * * For importers of dietary supplements and dietary supplement
components, the regulation on foreign supplier verification programs
can be found in subpart L of part 1 of this chapter.

    Dated: October 30, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-28158 Filed 11-13-15; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register Volume 87, Number 47 (Thursday, March 10, 2022)]
[Rules and Regulations]
[Pages 13644-13647]
[FR Doc No: 2022-05012]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 271

[EPA-R10-RCRA-2021-0439; FRL-8853-02-R10]

Oregon: Authorization of State Hazardous Waste Management Program
Revisions

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final authorization.

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SUMMARY: Oregon applied to the Environmental Protection Agency (EPA)
for final authorization of changes to its hazardous waste program under
the Resource Conservation and Recovery Act (RCRA), as amended. EPA has
reviewed Oregon's application and has determined that these changes
satisfy all requirements needed to qualify for

authorization. EPA sought public comment under Docket #EPA-R10-RCRA-
2021-0439 from October 5, 2021, to November 4, 2021, prior to taking
this final action to authorize these changes. EPA received five
comments, only one of which was adverse. EPA's response to the comment
and rationale for this final action are provided below.

DATES: This final authorization is effective April 11, 2022.

FOR FURTHER INFORMATION CONTACT: Margaret Olson, U.S. Environmental
Protection Agency, Region 10, Oregon Operations Office, 805 SW
Broadway, Suite 500, Portland, Oregon 97205, phone number: (503) 326-
5874, email: [email protected].

SUPPLEMENTARY INFORMATION:

A. Why are revisions to state programs necessary?

    States that have received final authorization from EPA under RCRA
section 3006(b), 42 U.S.C. 6926(b), must maintain a hazardous waste
program that is equivalent to, consistent with, and no less stringent
than the Federal program. As the Federal program changes, states must
change their programs and ask EPA to authorize the changes. Changes to
state programs may be necessary when Federal or State statutory or
regulatory authority is modified or when certain other changes occur.
Most commonly, states must change their programs because of changes to
EPA's regulations in 40 Code of Federal Regulations (CFR) parts 124,
260 through 268, 270, 273, and 279.
    Oregon State's hazardous waste management program received final
authorization on January 30, 1986 (51 FR 3779), to implement the RCRA
hazardous waste management program. As explained in section E of this
document, Oregon's program has been revised and reauthorized numerous
times since then. On October 16, 2020, Oregon submitted a complete
program revision application seeking authorization of changes to its
hazardous waste program that correspond to certain Federal rules
promulgated between October 22, 1998, and April 17, 2015. The below
rules have been adopted by Oregon as of July 12, 2017. The Federal
rules adopted by Oregon include the Hazardous Waste Manifest Printing
Specifications Correction Rule (76 FR 36363, June 22, 2011), Standards
Applicable to Owners and Operators of Closed and Closing Hazardous
Waste Management Facilities: Post-Closure Permit Requirement; Closure
Process (63 FR 56710, October 22, 1998), Used Oil Management Standards
(75 FR 76633, September 8, 2005), Standardized Permit for RCRA HW
Management Facilities (70 FR 53420, September 8, 2005), NESHAP:
Standards for RCRA HW Management Facilities (73 FR 18970, April 8,
2008), Amendment to Hazardous Waste Code F019 (73 FR 31756, June, 4,
2008), Academic Laboratories Generator Standards (73 FR 72911, December
1, 2008), Export Shipments of Lead-Acid Batteries (75 FR 1236, January
9, 2010), Hazardous Waste Technical Corrections and Clarifications Rule
(75 FR 12989, March 18, 2010), Withdrawal of the Emissions Comparable
Fuel Exclusion (75 FR 33712, June 5, 2010), Removal of Saccharin and
its Salt from the Lists of Hazardous Constituents (75 FR 78918,
December 17, 2010), Academic Laboratories Generator Standards Technical
Corrections (75 FR 79304, December 20, 2010), Revision of the Treatment
Standards for Carbamate Wastes (76 FR 34147, June 13, 2011), Hazardous
Waste Technical Corrections and Clarifications Rule (77 FR 22229, July
31, 2013), Conditional Exclusions for Solvent-Contaminated Wipes (78 FR
46447, July 31, 2013), Modifications of Hazardous Waste Manifest
System: Electronic Manifest (79 FR 7518, February 7, 2014), Revisions
to the Export Provisions of the Cathode Ray Tube (78 FR 36220, June 26,
2014), Vacatur of the Comparable Fuels Rule and the Gasification Rule
(80 FR 18777, April 8, 2015), and Disposal of Coal Combustion Residues
from Electric Utilities (80 FR 21301, April 17, 2015). Of the 19 rules
being authorized by this action, some State rules contain more
stringent and/or broader in scope provisions. For identification of
these provisions refer to the authorization revision application's
Attorney General Statement and Checklists found in the docket for this
action.
    The EPA is authorizing Oregon's revised hazardous waste program in
its entirety through July 12, 2017, as described above.

B. What decisions has EPA made in this action?

    EPA has reviewed Oregon's application to revise its authorized
program and has determined that it meets the statutory and regulatory
requirements established by RCRA. Therefore, EPA is granting Oregon
final authorization to operate its hazardous waste management program
with the changes described in the authorization revision application
and supporting materials. Oregon will continue to have responsibility
for permitting Treatment, Storage, and Disposal Facilities (TSDFs)
within its borders (except in Indian country (18 U.S.C. 1151)) and for
carrying out the aspects of the RCRA program described in its revised
program application, subject to the limitations of the Hazardous and
Solid Waste Amendments of 1984 (HSWA). New Federal requirements and
prohibitions imposed by Federal regulations that EPA promulgates under
the authority of HSWA, and which are not less stringent than existing
requirements, take effect in authorized States before the States are
authorized for the requirements. Thus, EPA will implement those
requirements and prohibitions in Oregon, including issuing permits,
until Oregon is granted authorization to do so.

C. What is the effect of this final authorization decision?

    A person in Oregon subject to RCRA must comply with the authorized
State requirements in lieu of the corresponding Federal requirements.
Additionally, such persons will have to comply with any applicable
Federal requirements, such as HSWA regulations issued by EPA for which
the State has not received authorization and RCRA requirements that are
not supplanted by the authorized State requirements. Oregon will
continue to have primary enforcement authority and responsibility for
its State hazardous waste program. EPA will maintain its authorities
under RCRA sections 3007, 3008, 3013, and 7003, including its authority
to:
     Conduct inspections, and require monitoring, tests,
analyses and reports;
     Enforce RCRA requirements, including authorized State
program requirements;
     Suspend or revoke permits; and
     Take enforcement actions regardless of whether the State
has taken its own actions.
    This action will not impose additional requirements on the
regulated community because the regulations which EPA is proposing to
authorize in Oregon are already effective under state law and are not
changed by the act of authorization.

D. What were the comments received on this authorization action?

    The EPA received five comments during the public comment period of
this action (86 FR 54894, October 5, 2021), four of which were
supportive, and one of which was opposed to this action. All the
comments received are included in the docket for this action.
    The adverse commenter questioned EPA's authorization of Oregon's
rule conditionally excluding solvent-contaminated wipes from RCRA

requirements, stating: ``why is Oregon proposing a more stringent
ruling on solvent-contaminated wipes when they can easily be excluded
using broad language under the EPA?'' The commenter also raised
questions about how solvent-contaminated wipes would be managed under
Oregon's rule. According to the commenter, ``[t]he plan for how the
wipes will be taken care of now that they are classified as hazardous
waste should be addressed before the approval is completed for this
proposal.''
    RCRA Section 3006 sets forth three criteria EPA must evaluate in
determining whether to authorize a State program: Whether the State
program is equivalent to the Federal program; whether the State program
is consistent with Federal or State programs applicable in other
States; and, whether the State program provides adequate enforcement of
compliance with RCRA requirements. In addition, under RCRA Section
3009, states may adopt RCRA programs that are more stringent than
Federal regulations, and EPA may authorize and enforce such more-
stringent regulations. See 40 CFR 271.1(i)(1).
    As noted in EPA's proposed action and in this final authorization,
EPA has determined that Oregon's changes to its hazardous waste
program--including the State's adoption of the conditional exclusion
for solvent-contaminated wipes--meet the statutory criteria for
authorization under RCRA Sections 3006 and 3009. EPA's exclusion for
solvent-contaminated wipes is codified at 40 CFR 261.4(b)(18), and
Oregon adopts by reference that provision at OAR<PHONE_NUMBER>(1), with
the exception of changes to the Federal rule identified at OAR 340-101-
0004(3) through (5), which eliminate certain disposal options from the
exclusion. In other words, Oregon's rules are consistent with EPA's
rules with regard to management of excluded solvent-contaminated wipes
and are more stringent with regard to their disposal. Thus, EPA has
determined that Oregon's requested changes to its hazardous waste
program are consistent with RCRA requirements and is finalizing
authorization of those changes in this action.

E. What has Oregon previously been authorized for?

    Oregon initially received final authorization on January 30, 1986,
effective January 31, 1986 (51 FR 3779), to implement the RCRA
hazardous waste management program. EPA granted authorization for
changes to Oregon's program on March 30, 1990, effective on May 29,
1990 (55 FR 11909); August 5, 1994, effective October 4, 1994 (59 FR
39967); June 16, 1995, effective August 15, 1995 (60 FR 31642); October
10, 1995, effective December 7, 1995 (60 FR 52629); September 10, 2002,
effective September 10, 2002 (67 FR 57337); June 26, 2006 effective
June 26, 2006 (71 FR 36216); and January 7, 2010, effective January 7,
2010 (75 FR 918).

F. What changes is the EPA authorizing with this action?

    EPA is authorizing revisions to Oregon's authorized RCRA program as
described in Oregon's official program revision application, submitted
to EPA on October 16, 2020, and deemed complete by EPA on November 19,
2020. EPA has determined that Oregon's hazardous waste management
program revisions as described in the October 16, 2020 State's
authorization revision application satisfy the requirements necessary
to quality for final authorization. Oregon's authorized hazardous waste
management program, as amended by these provisions remains equivalent
to, consistent with, and is no less stringent than the Federal RCRA
program. Therefore, EPA is granting Oregon's request for RCRA program
authorization revision for the program changes as noted in Section A of
this document.

G. Where are the revised State rules different from the Federal rules?

    Under RCRA Section 3009, the EPA may not authorize State rules that
are less stringent than the Federal program. Any State rules that are
less stringent do not supplant the Federal regulations. State rules
that are broader in scope than the Federal program requirements are
allowed but are not authorized. State rules that are equivalent to,
determined functionally equivalent, and State rules that are more
stringent than the Federal program may be authorized, in which case
those provisions are federally enforceable.
    The following Oregon provisions documented in this authorization
action are more stringent than the Federal program:
     Oregon is more stringent than the Federal program at OAR
340-102-0041(2) by requiring annual reporting rather than biennial
reporting.
     Oregon is more stringent than the Federal program at OAR
340-102-0200(4) which requires when opting-in to Subpart K, an eligible
academic entity is required to submit their completed Laboratory
Management Plan as defined in 40 CFR 262.214.
     Oregon is more stringent than the Federal program at OAR
340-102-0200(2) which requires container labels be affixed or attached
to the container and eliminates the possibility of these labels being
associated with the wrong container.
     Oregon is more stringent than the Federal program at OAR
340-101-0004(4) and (5) by requiring containers of solvent contaminated
wipes be either laundered or disposed as hazardous waste. Oregon does
not allow disposal of solvent contaminated wipes in a municipal
landfill or non-hazardous waste incinerator.
    Oregon is broader in scope than the Federal program documented in
this authorization action by requiring academic laboratories that opt
into subpart K to obtain an EPA identification number.

H. Who handles permits after the final authorization takes effect?

    Oregon will continue to issue permits for all the provisions for
which it is authorized and will administer the permits it issues.
Permits issued by EPA prior to authorizing Oregon for these revisions
would continue in force until the effective date of the State's
issuance or denial of a State hazardous waste management permit, at
which time, EPA would modify the existing EPA permit to expire at an
earlier date, terminate the existing EPA permit, or allow the existing
EPA permit to otherwise expire by its terms, except for those
facilities located in Indian Country. EPA will not issue new permits or
new portions of permits for provisions for which Oregon is authorized
after the effective date of this authorization. EPA will continue to
implement and issue permits for HSWA requirements for which Oregon is
not yet authorized.

I. How does this action affect Indian country (18 U.S.C. 1151) in
Oregon?

    Oregon is not authorized to carry out its hazardous waste program
in Indian country within the State, which includes:
     All lands within the exterior boundaries of Indian
reservations within or abutting the State of Oregon.
     Any land held in trust by the U.S. for an Indian tribe;
and
     Any other land, whether on or off an Indian reservation,
that qualifies as Indian country.
    Therefore, this action has no effect on Indian country. EPA retains
jurisdiction over Indian country and will continue to implement and
administer the RCRA program on these lands.

J. Statutory and Executive Order Reviews

    The Office of Management and Budget (OMB) has exempted this action
from the requirements of Executive Order 12866 (58 FR 51735, October 4,
1993) and 13563 (76 FR 3821, January 21, 2011). This action will
authorize State requirements for the purpose of RCRA section 3006 and
imposes no additional requirements beyond those imposed by State law.
Therefore, this action is not subject to review by OMB. Accordingly, I
certify that this action will not have a significant economic impact on
a substantial number of small entities under the Regulatory Flexibility
Act (5 U.S.C. 601 et seq.). Because this action authorizes pre-existing
requirements under State law and does not impose any additional
enforceable duty beyond that required by State law, it does not contain
any unfunded mandate or significantly or uniquely affect small
governments, as described in the Unfunded Mandates Reform Act of 1995
(2 U.S.C. 1531-1538). For the same reason, this action also does not
significantly or uniquely affect the communities of tribal governments,
as specified by Executive Order 13175 (65 FR 67249, November 9, 2000).
This action will not have substantial direct effects on the states, on
the relationship between the National Government and the states, or on
the distribution of power and responsibilities among the various levels
of government, as specified in Executive Order 13132 (64 FR 43255,
August 10, 1999), because it merely authorizes State requirements as
part of the State RCRA hazardous waste program without altering the
relationship or the distribution of power and responsibilities
established by RCRA. This action also is not subject to Executive Order
13045 (62 FR 19885, April 23, 1997) because it is not economically
significant, and it does not make decisions based on environmental
health or safety risks. This action is not subject to Executive Order
13211, ``Actions Concerning Regulations That Significantly Affect
Energy Supply, Distribution, or Use'' (66 FR 28355, May 22, 2001),
because it is not a significant regulatory action under Executive Order
12866.
    Under RCRA section 3006(b), the EPA grants a state's application
for authorization as long as the state meets the criteria required by
RCRA. It would thus be inconsistent with applicable law for EPA, when
it reviews a state authorization application, to require the use of any
particular voluntary consensus standard in place of another standard
that otherwise satisfies the requirements of RCRA. Thus, the
requirements of section 12(d) of the National Technology Transfer and
Advancement Act of 1995 (15 U.S.C. 272 note) do not apply. As required
by section 3 of Executive Order 12988 (61 FR 4729, February 7, 1996),
in authorizing Oregon's updated RCRA program, EPA has taken the
necessary steps to eliminate drafting errors and ambiguity, minimize
potential litigation, and provide a clear legal standard for affected
conduct. EPA has complied with Executive Order 12630 (53 FR 8859, March
15, 1988) by examining the takings implications of this action in
accordance with the ``Attorney General's Supplemental Guidelines for
the Evaluation of Risk and Avoidance of Unanticipated Takings'' issued
under the executive order. This action does not impose an information
collection burden under the provisions of the Paperwork Reduction Act
of 1995 (44 U.S.C. 3501 et seq.). ``Burden'' is defined at 5 CFR
1320.3(b).
    Executive Order 12898 (59 FR 7629, February 16, 1994) establishes
Federal executive policy on environmental justice. Its main provision
directs Federal agencies, to the greatest extent practicable and
permitted by law, to make environmental justice part of their mission
by identifying and addressing, as appropriate, disproportionately high
and adverse human health or environmental effects of their programs,
policies, and activities on minority populations and low-income
populations in the United States. Because this action authorizes pre-
existing State rules which are at least equivalent to, and no less
stringent than existing Federal requirements, and imposes no additional
requirements beyond those imposed by State law, and there are no
anticipated significant adverse human health or environmental effects,
this action is not subject to Executive Order 12898.
    The Congressional Review Act, 5 U.S.C. 801-808, generally provides
that before a rule may take effect, the agency promulgating the rule
must submit a rule report, which includes a copy of the rule, to each
House of the Congress and to the Comptroller General of the United
States. EPA will submit a report containing this document and other
required information to the U.S. Senate, the U.S. House of
Representatives, and the Comptroller General of the United States prior
to publication in the Federal Register. A major rule cannot take effect
until 60 days after it is published in the Federal Register. This
action is not a ``major rule'' as defined by 5 U.S.C. 804(2).

    Authority: This action is issued under the authority of sections
2002(a), 3006, and 7004(b) of the Solid Waste Disposal Act as
amended, 42 U.S.C. 6912(a), 6926, and 6974(b).

    Dated: March 4, 2022.
Michelle Pirzadeh,
Acting Regional Administrator, Region 10.
[FR Doc. 2022-05012 Filed 3-9-22; 8:45 am]
BILLING CODE 6560-50-P