But with this much of a major change in regulations, there will be areas where more guidance is needed from FDA for companies to figure out how to comply. This is the case where these 6 issues resulted in the compliance dates being moved back, essentially 2 years from the proposed compliance date.
- certain related provisions concerning customer assurances when controls are applied downstream in the distribution chain in all four rules.
- for facilities solely engaged in packing and/or holding activities conducted on raw agricultural commodities (RACs) that are produce and/or nut hulls and shells and for certain facilities that would qualify as secondary activities farms except for the ownership of the facility.
- for certain facilities that color RACs.
- for facilities solely engaged in the ginning of cotton.
- for importation of food contact substances.
- for certain facilities producing Grade “A” milk and milk products covered by the National Conference on Interstate Milk Shipments (NCIMS) under the Pasteurized Milk Ordinance (PMO) to comply with the CGMP requirements of part 117.
The other impactful section being delayed is for facilities holding or packing raw agricultural commodities that are not classified as a farm. These facilities are more like a farm than a processor, but because of the way the rule was written, it classifies them more as a processor. To help determine what these facilities need to do, FDA will write a specific guidance for these facilities. (Specific sections of the posting below)
Selected sections from:
The Food and Drug Administration Food Safety Modernization Act; Extension and Clarification of Compliance Dates for Certain Provisions of Four Implementing Rules
Final Rule; Extension And Clarification Of Compliance Dates For Certain Provisions.
https://www.federalregister.gov/articles/2016/08/24/2016-20176/the-food-and-drug-administration-food-safety-modernization-act-extension-and-clarification-of#t-1
II. Summary of Compliance Date Extensions in This Rule Back to Top
We are extending the dates for compliance with certain provisions in four final rules to address concerns about the practicality of compliance with certain provisions, consider changes to the regulatory text, and better align compliance dates across the rules.
First, we are extending the compliance dates for certain related provisions concerning customer assurances when controls are applied downstream in the distribution chain in all four rules.
Second, we are extending the compliance dates for part 117 and part 507 for facilities solely engaged in packing and/or holding activities conducted on raw agricultural commodities (RACs) that are produce and/or nut hulls and shells and for certain facilities that would qualify as secondary activities farms except for the ownership of the facility.
Third, we are extending the compliance dates for part 117 for certain facilities that color RACs.
Fourth, we are extending the compliance dates for part 507 for facilities solely engaged in the ginning of cotton.
Fifth, we are extending the compliance dates for the FSVP regulation for importation of food contact substances.
Sixth, we are extending the date for certain facilities producing Grade “A” milk and milk products covered by the National Conference on Interstate Milk Shipments (NCIMS) under the Pasteurized Milk Ordinance (PMO) to comply with the CGMP requirements of part 117.
1. Written Assurances From Customers
Extension of the compliance dates for certain related provisions concerning customer assurances when controls are applied downstream in the distribution chain in all four rules
Sections actually affected from Preventive Control for Human Foods
117.136 Circumstances in which the owner, operator, or agent in charge of a manufacturing/processing facility is not required to implement a preventive control.
(a) Circumstances. If you are a manufacturer/processor, you are not required to implement a preventive control when you identify a hazard requiring a preventive control (identified hazard) and any of the following circumstances apply:
(2) You rely on your customer who is subject to the requirements for hazard analysis and risk-based preventive controls in this subpart C to ensure that the identified hazard will be significantly minimized or prevented and you:
(ii) Annually obtain from your customer written assurance, subject to the requirements of §117.137, that the customer has established and is following procedures (identified in the written assurance) that will significantly minimize or prevent the identified hazard.
Sections actually affected from Preventive Control for Animal Foods
§ 507.36 Circumstances in which the owner, operator, or agent in charge of a manufacturing/processing facility is not required to implement a preventive control.
a) If you are a manufacturer/processor, you are not required to implement a preventive control when you identify a hazard requiring a preventive control (identified hazard) and any of the following circumstances apply:
(2) You rely on your customer who is subject to the requirements for hazard analysis and risk-based preventive controls in subpart C of this part to ensure that the identified hazard will be significantly minimized or prevented; and you:
(ii) Annually obtain from your customer written assurance, subject to the requirements of § 507.37, that the customer has established and is following procedures (identified in the written assurance) that will significantly minimize or prevent the identified hazard (except as provided in paragraph (c) of this section);
(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 this part to provide assurance it is manufacturing, processing, or preparing the animal food in accordance with applicable animal food safety requirements and you:
(ii) Annually obtain from your customer written assurance that it is manufacturing, processing, or preparing the animal food in accordance with applicable animal food safety requirements;
(4) You rely on your customer to provide assurance that the animal food will be processed to control the identified hazard by an entity in the distribution chain subsequent to the customer and you:
(ii) Annually obtain from your customer written assurance, subject to the requirements of § 507.37, that your customer:
From the Extension Notice on the Customer Requirement Provision
On March 23, 2016, FDA met with the Grocery Manufacturers Association (GMA) at their request to listen to concerns regarding the customer provisions in the part 117 rule (Ref. 1). GMA provided examples of product distribution chains that would require vastly more written assurances and consequently resources to comply with the requirement than anticipated by FDA. For example, a manufacturing facility may sell such foods to a distributor, who may sell numerous items requiring assurances to multiple restaurants, cafeterias, delicatessens, and other distributors. GMA estimated that this could result in hundreds or even thousands of written assurances needed by a single distributor. A similar concern exists for the related rules.
After considering the information presented by GMA, FDA believes that the requirement for written assurance in the customer provisions of part 117 significantly exceeds the current practices of even the largest facilities; compliance by those facilities by September 19, 2016, may not be feasible; and it is appropriate to extend the compliance dates for 2 years for the written assurance requirements for part 117 and the related rules while FDA considers the best approach to address feasibility concerns.
We believe it continues to be appropriate to provide for an entity earlier in the distribution chain to disclose that a hazard has not been controlled and rely on a subsequent entity to control a hazard in human or animal food. For example, it would not make sense to require a facility that chops nuts to have a preventive control for Salmonella if the nuts are going to be used by customers in baked goods in accordance with a process validated to adequately control the hazard. In addition, it would not make sense to require a facility that manufactures a rendered meat ingredient for pet food to have a preventive control for Salmonella when the final pet food will go through an extrusion process at a customer's facility to control Salmonella. A manufacturer/processor under part 117 or part 507 that relies on a customer to control a hazard will continue to be required to comply with the disclosure statement provisions and disclose that the food has not been processed to control the hazard on the compliance date originally specified (we note that FDA will soon be making available for public comment draft guidance on the disclosure statement provisions). Subsequent entities in the distribution chain will continue to be subject to applicable requirements related to food adulteration in Federal and/or state and local laws and regulations, e.g., part 117, part 507, and the Retail Food Code.
2. Extension for the compliance dates for part 117 and part 507 for facilities solely engaged in packing and/or holding activities conducted on raw agricultural commodities (RACs) that are produce and/or nut hulls and shells and for certain facilities that would qualify as secondary activities farms except for the ownership of the facility.
A. Facilities Solely Engaged in Packing and/or Holding Activities Conducted on Produce RACs and/or Nut Hulls and Shells
Some facilities that are subject to part 117 are solely engaged in packing and/or holding RACs that are produce (“produce RACs”). These activities are similar to packing and holding activities commonly conducted on produce RACs by farms subject to the produce safety regulation. Examples of such facilities are produce packinghouses, warehouses that hold produce RACs, and facilities that hull, shell, pack and/or hold nuts (nuts are produce RACs and hulling and shelling may be considered “packing” when done for safe or effective packing). (We note that FDA will soon be making available for public comment a draft guidance on classification of activities as harvesting, packing, holding, or manufacturing/processing for farms and facilities). During the rulemaking to establish part 117, we received comments asking us to revise the regulatory text to ensure that similar activities would be treated similarly under either the produce safety regulation or part 117. (See Comment 25, 80 FR 55908 at 55927 to 55928.)
We received comments that expressed concern about how the requirements in part 117 for environmental monitoring and product testing would apply to off-farm facilities that pack or hold produce RACs. (See Comment 524, 80 FR 55908 at 56062.) In responding to those comments, we stated that we were considering developing a separate guidance on packing and holding operations for produce RACs in light of the questions we have received regarding similarities and differences for off-farm packing and holding compared to on-farm packing and holding. In a letter to us dated April 19, 2016, the United Fresh Produce Association and 21 other organizations (UFPA et al.) noted that such guidance has not been issued, and the September 19, 2016, compliance date for part 117 is approaching (Ref. 2).
1. Similarities of Packing and Holding Activities Conducted on Produce RACs
In the preamble of the final rule establishing part 117, we described several changes to the regulatory text in response to comments asking us to consider revisions to ensure that similar activities would be treated the same way under either the produce safety regulation or part 117. (See Response 25, 80 FR 55908 at 55928 to 5929.) For example, we revised the “farm” definition to provide for two types of farms: (1) A primary production farm and (2) a secondary activities farm (see §§ 1.227 and 117.3). With the added definition of “secondary activities farm,” some packinghouses that are managed by a business entity (such as a cooperative) that is different from the business entity growing crops (such as individual farms) can be within the “farm” definition and, thus, not be subject to the human food preventive controls requirements. We also established a new provision to allow off-farm establishments that package, pack, and hold produce RACs to comply with the CGMPs in part 117 by complying with the relevant requirements for packing and holding in the final produce safety regulation (see § 117.8).
In responding to these comments, we noted that the revised “farm” definition did not, as requested, provide for all off-farm operations such as certain packinghouses and hulling/shelling operations to be subject to the produce safety regulation rather than part 117. We explained that the statutory framework does not provide for entities such as packinghouses and hulling/shelling operations that do not have a sufficient connection to a farm to be subject to the requirements of the produce safety regulation. However, we stated that we continued to believe that an off-farm packinghouse that is subject to the human food preventive controls requirements in part 117 will be able to draw from the provisions of the produce safety regulation in developing its food safety plan and establishing preventive control management components that are appropriate in light of the nature of the preventive controls and their role in the facility's food safety system. For example, we stated our expectation that the food safety plan for an off-farm packinghouse would focus on a few key preventive controls, including some that would have counterparts in the produce safety regulation, such as maintaining and monitoring the temperature of water used during packing (which would have counterparts under § 112.48(c) in the produce safety regulation). We also expected that an off-farm packinghouse would establish sanitation controls to address the cleanliness of food-contact surfaces (including food-contact surfaces of utensils and equipment) and the prevention of cross-contamination from insanitary objects and from personnel to food, food-packaging material, and other food-contact surfaces. On-farm packinghouses would be subject to similar, but not identical, requirements (see, e.g., §§ 112.111(b) and 112.123(d)(1) for cleanliness of food-contact surfaces, and §§ 112.113 and 112.132 for protection against contamination).
We agree that certain activities conducted on produce RACs are similar regardless of where they happen. Therefore, facilities for which the packing and/or holding of produce RACs is subject to the human food preventive controls requirements may nonetheless still be able to draw from the provisions of the produce safety regulation in developing their food safety plans and establishing preventive control management components that are appropriate in light of the nature of the preventive controls and their role in the facility's food safety system. We acknowledge that we have not yet issued guidance with specific recommendations for how packinghouses subject to the human food preventive controls requirements could comply with those requirements.
2. Extension of Compliance Dates for Facilities Solely Engaged in Packing and/or Holding Produce RACs and/or Nut Hulls and
We published the final rule establishing part 117 more than 2 months before we published the final rule establishing the produce safety regulation and, thus, the compliance dates for the produce safety regulation had not yet been established. To provide facilities that are solely engaged in packing and/or holding activities on produce RACs the same time to understand the applicable provisions of the produce safety regulation as farms that conduct similar packing and holding activities, and to enable such facilities to develop a food safety plan that builds on the requirements of the produce safety regulation, where applicable, we are extending the date for facilities that are solely engaged in packing and/or holding activities on produce RACs to comply with part 117 by approximately 16 months to make the compliance dates the same as for businesses in the same size categories in the produce safety regulation. For example, the new compliance date for a facility that is a small business under part 117 is the compliance date for a small business under the produce safety regulation, regardless of whether the facility subject to part 117 would be considered a small business under the produce safety regulation. (Note that the produce safety regulation has different compliance dates associated with sprouts but for the purposes of this extension we are not establishing different dates for sprouts.) This will match the other extended compliance dates that relate to the “farm” definition or the produce safety regulation in this document.
With the extension, eligible facilities that are very small businesses must comply with part 117 by January 27, 2020; eligible facilities that are small businesses must comply by January 28, 2019, and all other eligible facilities must comply by January 26, 2018. We are extending compliance dates for very small businesses because, although they are not required to comply with subparts C and G (e.g., they are not required to have food safety plans), one of their options for compliance includes identifying the potential hazards associated with the food being produced, implementing preventive controls to address the hazards, and monitoring the performance of the preventive controls to ensure that such controls are effective (21 CFR 117.201(a)(2)(i)).
To maintain the intended alignment between part 117 and part 507, we also are making a parallel extension to the dates for facilities that are solely engaged in packing and/or holding activities on produce RACs that are used as animal food to comply with part 507 requirements. While there may be limited facilities that pack and hold produce RACs exclusively for animal food, the by-products, such as culls, from packing and holding of produce RACs for human food are often used as animal food. The rulemaking to establish part 507 included a provision for certain human food by-products used as animal food (§ 507.12). To qualify for § 507.12, the human food facility whose packing or holding of produce results in by-products for use as animal food must be in compliance with the part 117 CGMPs or in compliance with the applicable requirements for packing and holding in part 112. The extension of compliance dates allows for facilities that are providing by-products for use as animal food time to implement the applicable part 117 or part 112 requirements. The parallel 16 month compliance date extension for part 507 is staggered to allow time for such operations to first comply with the part 507 CGMP requirements, including the related requirement in § 507.12. With the extension, eligible facilities that are very small businesses must comply with the CGMP requirements of part 507 by January 27, 2020, and with the preventive controls requirements of part 507 by January 26, 2021; eligible facilities that are small businesses must comply with the CGMP requirements of part 507 by January 28, 2019, and with the preventive controls requirements of part 507 by January 27, 2020, and all other eligible facilities must comply with the CGMP requirements of part 507 by January 26, 2018, and with the preventive controls requirements of part 507 by January 28, 2019.
In addition, nut hulls and shells are used for animal food and result from some activities performed by those facilities that are receiving an extension to comply with part 117. Therefore, we are extending the compliance dates for animal food preventive controls requirements for facilities solely engaged in packing and/or holding activities conducted on nut hulls and shells. Facilities that are solely engaged in hulling, shelling, drying, packing, and/or holding of nuts and hulls are exempt from the part 507 CGMP requirements (§ 507.5(h)(2)) and will continue to remain exempt. With the extension, eligible facilities that are very small businesses must comply with animal food preventive controls requirements by January 26, 2021; eligible facilities that are small businesses must comply by January 27, 2020, and all other eligible facilities must comply by January 28, 2019.
The extended compliance dates do not apply to facilities that manufacture/process produce RACs or nut hulls and shells in addition to packing and/or holding produce RACs or nut hulls and shells, because such facilities must come into compliance with part 117 and part 507 with respect to their manufacturing/processing as well as their packing and holding. Examples of facilities to which the extended compliance dates apply are packinghouses that solely pack and/or hold produce RACs; and facilities that solely hull, shell, pack, and/or hold nuts (nuts are produce RACs and hulling and shelling may be considered “packing” when done for safe or effective packing). Examples of manufacturing/processing facilities to which the extended compliance dates do not apply are a “fresh-cut” processing facility, such as a facility that produces bagged salad mixes or packages of sliced fruit, and a facility that grinds nut shells to make an animal food ingredient.
Certain Facilities That Would Qualify as Secondary Activities Farms Except for the Ownership of the Facility
The rulemaking to establish part 117 created a “secondary activities farm” definition within the “farm” definition to cover certain operations that are not located on a primary production farm but are sufficiently related to a primary production farm so that it is appropriate to consider the operations to be farms (§ 1.227). A secondary activities farm is devoted to harvesting (such as hulling or shelling), packing, and/or holding of RACs (such as produce, grains, and eggs). Further, a majority interest in a secondary activities farm must be majority-owned (singly or jointly) by the primary production farm(s) that grows, harvests, and/or raises the majority of the RACs harvested packed, and/or held by the secondary activities farm (§ 1.227).
We have received questions via our Technical Assistance Network regarding whether certain operations qualify as secondary activities farms under part 117 and part 507. These questions describe a variety of business structures that may satisfy our intention to require a close relationship regarding ownership of the primary and secondary activities farms but the business structures do not meet the ownership requirement as codified in the “farm” definition. For example, some operations that might otherwise qualify as secondary activities farms own the primary production farm, rather than being owned by the primary production farm as currently required. Other operations that might otherwise qualify as a secondary activities farm are operations that are not owned by (and do not own) the primary production farm but are majority owned by the same entity as the primary production farm. For example, Farm A is a primary production farm. Facility B is a produce packinghouse that packs only produce from Farm A. Farm A and Facility B are both part of Corporation C. Despite the close relationship, Facility B is not a secondary activities farm under the current definition because Farm A does not own a majority interest in Facility B.
We are extending the compliance dates for certain operations that would be secondary activities farms except that they do not meet the ownership criterion in the definition. The extension is applicable only to an operation satisfying all of the following requirements: (1) The operation is not located on a primary production farm; (2) the operation is devoted to harvesting, packing, and/or holding of RACs (including operations that hull, shell, and/or dry nuts without additional manufacturing); and (3) the operation is under common ownership with the primary production farm(s) that grows, harvests, and/or raises the majority of the RACs harvested, packed, and/or held by the operation. Examples of common ownership include an operation that is owned by (or that owns) one or more primary production farms (e.g., a packinghouse owned by a cooperative of individual farms) and an operation under common ownership with a primary production farm, such as operations that are managed within the same business structure as the primary production farm (e.g., the farm and packinghouse are separate operations owned by parents and their children, respectively, and both operations are part of the same business jointly owned by the parents and children). Other limitations on secondary activities farms remain. For example, feed mills manufacturing animal food for contract farms would not qualify because, among other reasons, those feed mills are conducting manufacturing/processing outside the farm definition.
We are extending the compliance dates for part 117 for operations satisfying all of the requirements by approximately 16 months to match the compliance dates for businesses in the same size categories in the produce safety regulation (note that the produce safety regulation has different compliance dates associated with sprouts but for purposes of this extension we are not establishing different dates for sprouts). This will match the other extended compliance dates that relate to the “farm” definition or the produce safety regulation in this document. With the extension, eligible facilities that are very small businesses must comply with part 117 by January 27, 2020; eligible facilities that are small businesses must comply by January 28, 2019, and all other eligible facilities must comply by January 26, 2018.
The parallel 16 month compliance date extension for part 507 is staggered to allow time for operations satisfying all of the requirements to first comply with the CGMP requirements. With the extension, eligible facilities that are very small businesses must comply with the CGMP requirements of part 507 by January 27, 2020, and with the preventive controls requirements of part 507 by January 26, 2021; eligible facilities that are small businesses must comply with the CGMP requirements of part 507 by January 28, 2019, and with the preventive controls requirements of part 507 by January 27, 2020, and all other eligible facilities must comply by with the CGMP requirements of part 507 by January 26, 2018, and with the preventive controls requirements of part 507 by January 28, 2019.
No comments:
Post a Comment