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| [Code of Federal Regulations] |
| [Title 21, Volume 2] |
| [CITE: 21CFR112] |
TITLE 21--FOOD AND DRUGS CHAPTER I--FOOD AND DRUG ADMINISTRATION DEPARTMENT OF HEALTH AND HUMAN SERVICES
SUBCHAPTER B - FOOD FOR HUMAN CONSUMPTION
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| PART 112 | STANDARDS FOR THE GROWING, HARVESTING, PACKING, AND HOLDING OF PRODUCE FOR HUMAN CONSUMPTION |
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Subpart P - Variances
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Sec. 112.171 Who may request a variance from the requirements of this part?
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A State, Federally-recognized tribe (or "tribe"), or a foreign country from which food is imported into the United States may request a variance from one or more requirements of this part, where the State, tribe, or foreign country determines that:
(a) The variance is necessary in light of local growing conditions; and
(b) The procedures, processes, and practices to be followed under the variance are reasonably likely to ensure that the produce is not adulterated under section 402 of the Federal Food, Drug, and Cosmetic Act and to provide the same level of public health protection as the requirements of this part.
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Sec. 112.172 How may a State, tribe, or foreign country request a variance from one or more requirements of this part?
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To request a variance from one or more requirements of this part, the competent authority (i.e., the regulatory authority for food safety) for a State, tribe, or a foreign country must submit a petition under § 10.30 of this chapter.
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Sec. 112.173 What must be included in the Statement of Grounds in a petition requesting a variance?
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In addition to the requirements set forth in § 10.30 of this chapter, the Statement of Grounds in a petition requesting a variance must:
(a) Provide a statement that the applicable State, tribe, or foreign country has determined that the variance is necessary in light of local growing conditions and that the procedures, processes, and practices to be followed under the variance are reasonably likely to ensure that the produce is not adulterated under section 402 of the Federal Food, Drug and Cosmetic Act and to provide the same level of public health protection as the requirements of this part;
(b) Describe with particularity the variance requested, including the persons to whom the variance would apply and the provision(s) of this part to which the variance would apply;
(c) Present information demonstrating that the procedures, processes, and practices to be followed under the variance are reasonably likely to ensure that the produce is not adulterated under section 402 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 342) and to provide the same level of public health protection as the requirements of this part.
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Sec. 112.174 What information submitted in a petition requesting a variance or submitted in comments on such a petition are publicly available?
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We will presume that information submitted in a petition requesting a variance and comments submitted on such a petition, including a request that a variance be applied to its similarly situated persons, does not contain information exempt from public disclosure under part 20 of this chapter and will be made public as part of the docket associated with this request.
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Sec. 112.175 Who responds to a petition requesting a variance?
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The Director or Deputy Directors of the Center for Food Safety and Applied Nutrition (CFSAN), or the Director, Office of Compliance, CFSAN, responds to a request for a variance.
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Sec. 112.176 What process applies to a petition requesting a variance?
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(a) In general, the procedures set forth in § 10.30 of this chapter govern our response to a petition requesting a variance.
(b) Under § 10.30(h)(3) of this chapter, we will publish a notice in the Federal Register, requesting information and views on a filed petition, including information and views from persons who could be affected by the variance if the petition were to be granted (e.g., because their farm is covered by the petition or as a person similarly situated to persons covered by the petition).
(c) Under § 10.30(e)(3) of this chapter, we will respond to the petitioner in writing and will also make public a notice on FDA's Web site announcing our decision to either grant or deny the petition.
(1) If we grant the petition, either in whole or in part, we will specify the persons to whom the variance applies and the provision(s) of this part to which the variance applies.
(2) If we deny the petition (including partial denials), our written response to the petitioner and our public notice announcing our decision to deny the petition will explain the reason(s) for the denial.
(d) We will make readily accessible to the public, and periodically update, a list of filed petitions requesting variances, including the status of each petition (for example, pending, granted, or denied).
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Sec. 112.177 Can an approved variance apply to any person other than those identified in the petition requesting that variance?
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(a) A State, tribe, or a foreign country that believes that a variance requested by a petition submitted by another State, tribe, or foreign country should also apply to similarly situated persons in its jurisdiction may request that the variance be applied to its similarly situated persons by submitting comments in accordance with § 10.30 of this chapter. These comments must include the information required in § 112.173. If FDA determines that these comments should instead be treated as a separate request for a variance, FDA will notify the State, tribe, or foreign country that submitted these comments that a separate request must be submitted in accordance with §§ 112.172 and 112.173.
(b) If we grant a petition requesting a variance, in whole or in part, we may specify that the variance also applies to persons in a specific location who are similarly situated to those identified in the petition.
(c) If we specify that the variance also applies to persons in a specific location who are similarly situated to those identified in the petition, we will inform the applicable State, tribe, or foreign country where the similarly situated persons are located of our decision in writing and will publish a notice on our Web site announcing our decision to apply the variance to similarly situated persons in that particular location.
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Sec. 112.178 Under what circumstances may FDA deny a petition requesting a variance?
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We may deny a variance request if it does not provide the information required under § 112.173 (including the requirements of § 10.30 of this chapter), or if we determine that the variance is not reasonably likely to ensure that the produce is not adulterated under section 402 of the Federal Food, Drug and Cosmetic Act and to provide the same level of public health protection as the requirements of this part.
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Sec. 112.179 When does a variance approved by FDA become effective?
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A variance approved by FDA becomes effective on the date of our written decision on the petition.
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Sec. 112.180 Under what circumstances may FDA modify or revoke an approved variance?
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We may modify or revoke a variance if we determine that such variance is not reasonably likely to ensure that the produce is not adulterated under section 402 of the Federal Food, Drug, and Cosmetic Act and to provide the same level of public health protection as the requirements of this part.
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Sec. 112.181 What procedures apply if FDA determines that an approved variance should be modified or revoked?
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(a) We will provide the following notifications:
(1) We will notify a State, tribe, or a foreign country directly, in writing at the address identified in its petition, if we determine that a variance granted in response to its petition should be modified or revoked. Our direct, written notification will provide the State, tribe, or foreign country with an opportunity to request an informal hearing under part 16 of this chapter.
(2) We will publish a notice of our determination that a variance should be modified or revoked in the Federal Register. This notice will establish a public docket so that interested parties may submit written comments on our determination.
(3) When applicable, we will:
(i) Notify in writing any States, tribes, or foreign countries where a variance applies to similarly situated persons of our determination that the variance should be modified or revoked;
(ii) Provide those States, tribes, or foreign countries with an opportunity to request an informal hearing under part 16 of this chapter; and
(iii) Include in the Federal Register notice described in paragraph (a)(2) of this section public notification of our decision to modify or revoke the variance granted to States, tribes, or foreign countries in which similarly situated persons are located.
(b) We will consider submissions from affected States, tribes, or foreign countries and from other interested parties as follows:
(1) We will consider requests for hearings by affected States, tribes, or foreign countries under part 16 of this chapter.
(i) If FDA grants a hearing, we will provide the State, tribe, or foreign country with an opportunity to make an oral submission. We will provide notice on our Web site of the hearing, including the time, date, and place of the hearing.
(ii) If more than one State, tribe, or foreign country requests an informal hearing under part 16 of this chapter about our determination that a particular variance should be modified or revoked, we may consolidate such requests (for example, into a single hearing).
(2) We will consider written submissions submitted to the public docket from interested parties.
(c) We will provide notice of our final decision as follows:
(1) On the basis of the administrative record, FDA will issue a written decision, as provided for under part 16 of this chapter.
(2) We will publish a notice of our decision in the Federal Register. The effective date of the decision will be the date of publication of the notice.
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Sec. 112.182 What are the permissible types of variances that may be granted?
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A variance(s) may be requested for one or more requirements in subparts A through O of this part. Examples of permissible types of variances include:
(a) Variance from the microbial quality criteria when agricultural water is used during growing activities for covered produce (other than sprouts) using a direct water application method, established in § 112.44(b);
(b) Variance from the microbial die-off rate that is used to determine the time interval between last irrigation and harvest, and/or the accompanying maximum time interval, established in § 112.45(b)(1)(i); and
(c) Variance from the approach or frequency for testing water used for purposes that are subject to the requirements of § 112.44(b), established in § 112.46(b).
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Authority: 21 U.S.C. 321, 331, 342, 350h, 371; 42 U.S.C. 243, 264, 271.
Source: 80 FR 74547, Nov. 27, 2015, unless otherwise noted.
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